Arch Orthop Trauma Surg (2014) 134:947–953 DOI 10.1007/s00402-014-1973-0
TRAUMA SURGERY
Treatment of non-union of humerus diaphyseal fractures: a prospective study comparing interlocking nail and locking compression plate Ashutosh Kumar Singh • G. R. Arun Nidhi Narsaria • Anurag Srivastava
•
Received: 22 October 2013 / Published online: 23 May 2014 Springer-Verlag Berlin Heidelberg 2014
Abstract Background The aim of this prospective comparative study was to compare outcomes and complications of humeral diaphyseal fracture non-unions managed with humerus interlocking nail (HIL) and locking compression plate (LCP). Materials and methods 40 patients with non-union of humeral diaphyseal fractures were included in this study and were randomly allocated in two groups; group A had 20 cases treated with HIL and group B had 20 cases treated with LCP. Clinico-radiological assessments were done for each case up to 2-year follow-up period. Primary outcome measures (time to fracture union, union rate) and secondary outcome measures (functional outcome and complication such as infection, malunion, delayed union, implant failure, joint stiffness and iatrogenic radial nerve palsy) were compared between both the groups. Disabilities of the arm, shoulder and hand (DASH) scoring and Steward and Hundley’s scoring system were used to assess functional outcome of the fracture fixation. Results There was no significant difference (p = 0.12) in terms of mean fracture union time between group A (15.8 ± 4.2 weeks) and group B (17.2 ± 3.8 weeks). Group A had 95 % union rate and group B had 100 %
A. K. Singh Department of Orthopedics, Mayo Institute of Medical Sciences, Barabanki, India G. R. Arun (&) Department of Orthopedics, Sri Mokambika Institute of Medical Sciences, Kanyakumari, India e-mail: [email protected] N. Narsaria A. Srivastava Mayo Institute of Medical Sciences, Barabanki, India
union rate (p = 0.14). At the 2-year follow-up visit, there was no significant difference found between both the groups regarding range of motion of shoulder and elbow joint. There was no significant difference found in final functional outcomes between both the groups on comparing DASH score (p = 0.14) and Steward and Hundley’s score (p = 0.08). In terms of complications, there was insignificant difference found between both the groups. Conclusions This study concludes that both the implants can be used in non-union of humeral shaft fractures with good functional outcomes and acceptable rate of complications. Keywords Humerus Locking compression plate Humerus interlocking nail Non-union Diaphyseal fractures Pseudoarthrosis
Introduction Fractures of the humeral shaft are relatively common and account for 3–5 % of all fractures [1]. 90–95 % of humerus fractures treated conservatively unite with good functional outcomes [2, 3]. Absolute indications for surgical fixation of humeral shaft fractures include fractures with neurovascular injury, open fractures, fractures with concomitant ipsilateral forearm fractures (floating elbow), patients with multiple injuries or polytrauma, progressive radial nerve deficits, pathologic fractures and failed non-operative management [4–6]. Relative indications include obese patients who do not tolerate brace and cast, patients with associated brachial plexus leading to inability to maintain bony alignment, and non-compliant patients [7, 8]. Following conservative or surgical treatment of humerus shaft fractures, 8–13 % nonunion rate has been reported [9, 10]. Non-union of humeral diaphyseal fractures, defined as a fracture with no evidence of
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radiological healing 6 months after injury, is a difficult problem to treat and might require multiple surgical procedures. Causes of humeral diaphyseal fracture non-unions are infection, distraction at fracture site, soft tissue interposition, unstable fixation, wrong choice of implant, iatrogenic devitalization of soft tissues, inadequate immobilization, open fractures, comminution and osteoporosis [11, 12]. Various devices used in treatment of humeral diaphyseal non-union are limited contact dynamic compression plates, locking compression plate (LCP), wave plates, humerus interlocking nail (HIL), Ilizarov external fixators and bone graft struts [13– 15]. Open reduction and internal fixation with plating is generally accepted as the best method of treatment for nonunion of fractures of the humerus in the adult with advantages of stable fixation, direct visualization, protection of the radial nerve, and sparing of the adjacent shoulder and elbow joint from injury and stiffness. LCP having features of compression and point bone–plate contact (minimum contact) is being used commonly for fixation of humeral shaft fractures non-union [16]. Circular external fixators have been used by many authors with acceptable outcomes [17, 18], but had certain disadvantages such as technical difficulty during fixator application, chances of neurovascular injury, restricted movement and pin-tract infections [14]. Intramedullary nail is also used in treatment of non-union of humerus fractures with advantage of being less invasive surgery, acts as a load sharing device, has less stress shielding and less chance of refracture after implant removal but distraction at fracture site, shoulder pain and stiffness is more common in nailing [19]. There are many clinical studies in the literature evaluating role of LCP [16, 19, 20] and HIL fixation [3, 21] in non-union of humerus shaft fractures and reported good functional outcome in both the methods. Our hypothesis states that the treatment of humeral diaphyseal fractures non-union with HIL and LCP would achieve comparable functional outcomes and acceptable complications. To the best of our knowledge, there is no study reporting comparison of LCP and HIL in treatment of non-union of humeral diaphyseal fractures. The aim of this study was to compare the clinico-radiological outcomes in terms of range of movements, radiological parameters, functional scores and complications in non-union of humerus diaphyseal fractures treated with LCP and HIL.
Materials and methods The protocol of this study was approved by the institutional review board. This study was authorized by the local ethical committee and was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki as revised in 2000. Informed written consent was taken from all the patients. A power analysis, with a power of 80 % to
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detect DASH score difference of ten as being significant at the 5 % level, determined the sample size of 40 cases considering 10 to 15 % drop out rate during the follow-up. Each group required at least 20 cases. 40 patients with nonunion of diaphyseal fractures of humerus were included in this study as per inclusion criteria. The inclusion criteria were as follows: • •
Age [16 years and \65 years diaphyseal humerus fracture non-union following conservative or operative treatment The exclusion criteria were:
• • • • •
infective non-union associated medical complications for surgery associated nerve injury non-union of extraarticular fractures in the proximal and distal 5 cm of the humerus pathological fractures.
All the cases included in this study were randomized into two groups by sealed envelop method, patients treated with antegrade interlock nailing (group A) and those treated with 4.5 mm LCP (group B). Demographic profile of both the groups are shown in Table 1. In all the cases surgery was performed under general anesthesia by the same orthopedic surgeon, with the patient placed in the lateral decubitus position, using the posterior approach. In cases with implant in situ, implant was removed first then dissection was carried out down to the non-union site and radial nerve was identified. Both the proximal and distal fragment ends with intramedullary canal were then debrided of all soft tissue and resected back to bleeding bone. Culture was sent. In group A, antegrade interlock nailing (Synthes) was done. Proper reaming of the intramedullary canal of proximal and distal fragment of humerus was done (Fig. 1a, b). We made entry portal to the superolateral surface of the greater tuberosity below the supraspinatus insertion which minimized the risk of rotator cuff injury and adhesive capsulitis. In group B, 4.5 mm LCP (Synthes) was applied with at least eight points of cortical fixation on both sides of the non-union. In cases where plate had been used in primary surgery, LCP with 10–12 holes was used. Autogenous cancellous graft was harvested from iliac crest in all the cases and non-union of fracture site was filled with this graft. After irrigation the wound was closed in a routine fashion. In post-operative period, patients were immobilized in a sling, while active and active-assisted range of motion began as soon as tolerated, generally at third day. All patients were followed up at 1-month intervals for the first 6 months after the surgery, then at 2-month intervals for the next 6 months and then at 3-month interval for next 1 year after surgery. Antero-posterior (AP) and lateral
Arch Orthop Trauma Surg (2014) 134:947–953 Table 1 Demographic profile of study
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Characteristics
Group A (interlock nailing)
Group B (locking compression plate)
p value
Age in years, mean (range)
34.6 ± 7.8 years (17–64 years)
36.8 ± 9.2 years (20–65 years)
0.62
Sex (male:female)
12:8
13:7
0.44
Right:left
11:9
12:8
0.36
9
10
0.82
Type of primary treatment received Conservative Intramedullary nailing
4
3
0.78
Plating External fixation
5 2
4 3
0.80 0.64
Average time from fracture to treatment of the non-union
18.2 ± 4.2 months (10.2–26.6 months)
20.8 ± 4.6 months (11–28.2 months)
0.24
Fig. 1 a X-ray showing non-union of humeral diaphyseal fracture in 36-year-old male with implant in situ. b Removal of implant, freshening of fracture edges, internal fixation with antegrade
interlocking nail and autogenous iliac crest bone grafting was done. X-ray at 3-month follow-up visit showing well-uniting fracture. c Xray at 12-month follow-up visit showing united fracture
radiographs were taken at each follow-up visit. Shoulder and elbow range of motion was assessed at each follow-up visit. Fracture union time, complications and functional outcomes were also recorded. Each patient completed the disabilities of the arm, shoulder and hand (DASH) questionnaire during the follow-up [22]. The DASH questionnaire is a validated health status questionnaire that results in a score ranging from 0 points, representing no disability, to 100 points, representing maximum disability. All patients were also evaluated on the basis of Steward and Hundley’s scoring system (Table 2) which consists of scores of shoulder and elbow movements along with pain and angulation and has three categories of good, fair and poor outcomes [23]. The complications were evaluated in terms of infections (superficial or deep or chronic osteomyelitis), delayed union, non-union, implant failure, secondary loss
Table 2 Steward and Hundley’s scoring for evaluation of functional outcome Rating
Limitation of elbow or shoulder movement ()
Pain
Angulation ()
Good Fair
\20
None
\10
20–40
After efforts [10 or work
Poor
[40
Permanent
Radiological non-union
of reduction and implant breakage. Malunion was defined as healing occurring at more than 15 of angulation. A delayed union was diagnosed when no satisfactory signs of healing were present at 16-week followup visit. A non-union was diagnosed when no radiological signs of healing had occurred after 6 months.
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Student’s t test was used to analyze the difference of mean for different parameters. The test was referenced for two-tailed p value and 95 % confidence interval was constructed around sensitivity proportion using normal approximation method. Statistical analyses were performed using SPSS software. A value \0.05 was considered statistically significant.
Arch Orthop Trauma Surg (2014) 134:947–953 Table 3 Comparison of functional scores between both the groups Functional scores
Group A
Group B
DASH score (mean ± SD)
12.8 ? 8.2
10.4 ? 10.4
Good
12
14
Fair
07
06
Poor
01
0
Steward and Hundley’s scoring
Results The average age in the group A was 34.6 ± 7.8 years (range 17–64 years) and in group B was 36.8 ± 9.2 years (range 20–65 years). Both groups showed no statistical difference in term of age (p = 0.62), gender (p = 0.44), affected side (p = 0.36) and time from injury to treatment for non-union (p = 0.24). In group A, 11 cases had implant used in primary fracture fixation including DCP, Enders nail, Rush nail, Kuntscher nail and tubular external fixator while in group B, ten cases had implant used in primary fracture fixation. Implant failure was obvious on the preoperative radiographs in 15 patients. 19 cases included in this study were treated conservatively primarily with plaster or brace. All the patients were followed for 2 years after surgery. The average time from injury to treatment of non-union in group A was 18.2 ± 4.2 months (10.2–26.6 months) and in group B, was 20.8 ± 4.6 months (11–28.2 months) and there was no statistical significance found between the two groups (p = 0.24). The mean fracture union time was 15.8 ± 4.2 weeks (range 10.4–52 weeks) in group A and 17.2 ± 3.8 weeks (range 12–46 weeks) in group B and there was no statistically significant difference found between the two groups (p = 0.12). Group A had 95 % union rate and group B had 100 % union rate (p = 0.14); (Fig. 1c, d). The average DASH score in group A (12.8 ± 8.2) was more than group B (10.4 ± 10.4) but there was no significant difference found (p = 0.14). According to Steward and Hundley’s scoring system, 12 cases had good functional outcome, seven cases had fair outcome and one case had poor outcome in group A while in group B, 14 cases had good outcome and six cases had fair outcome (Table 3). There was no significant difference found in terms of functional outcome of both the groups (p = 0.08). At the 24-month follow-up visit, there was no significant difference found regarding range of motion of shoulder and elbow joint of both the groups. Two patients (10 %) in group A and three patients (15 %) in group B had superficial infection (p = 0.64), which subsided uneventfully following antibiotic therapy. There was no incidence of deep infection in either group. The radial nerve was identified in all the cases during
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freshening of fracture edges. Iatrogenic radial nerve palsy was reported only in group B (10 %) and there was no significant difference found (p = 0.31) between both the groups. Both case of iatrogenic radial nerve palsies in group B spontaneously recovered with conservative treatment within 6 months. One case (5 %) had delayed union in group A which was treated conservatively and the fracture achieved solid union in 13 months after surgery. One case (5 %) in group A had non-union which was treated with nail removal, freshening of edges and LCP fixation with autologous iliac crest bone grafting and fracture achieved union uneventfully (Fig. 2a–d). There was no incidence of implant failure and implant removal was not done in any case of both groups up to 2-year follow-up visit (Table 4).
Discussion Humeral shaft fractures have a high rate of union whether treated conservatively or surgically. Non-union has been reported to occur in 8–12 % of all humeral shaft fractures [9]. Non-union rates between 0–13 % are reported for humeral diaphyseal fractures treated non-operatively [9, 25]. Some authors have reported still higher rate of nonunion in humeral shaft fractures treated surgically for appropriate indications (non-union rate up to 15–25 %) [24–26]. Management of non-union of the humeral shaft is a difficult problem. Conservative methods used in these non-union cases include casting, functional bracing, splints, electric stimulation and extracorporeal shock waves [14, 27, 28]. These methods have not been seen to be very useful and can be used only in selected cases. Surgical methods include compression plating, intramedullary exchange nailing, strut bone grafting and Ilizarov external fixator [15, 29, 30]. Freshening of fracture edges, plate fixation and cortico-cancellous bone grafting have been accepted as standard surgical treatment. Locked intramedullary nailing has been also used with advantages of need of less soft tissue dissection, less rate of infection and less chances of nerve injury [21] but nailing had been shown to be associated with some disadvantages like lack of compression at fracture site and distraction at fracture
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Fig. 2 a X-ray showing non-union of humeral diaphyseal fracture in 30-year-old female with implant in situ. b X-ray lateral view showing non-union in same case. c Removal of implant, freshening of fracture edges, internal fixation with antegrade interlocking nail and
autogenous iliac crest bone grafting was done. X-ray at 15-month follow-up visit showing non-union of fracture. d Revision surgery (removal of nail, freshening of fracture edges, internal fixation with LCP and autogenous iliac crest bone grafting) done
Table 4 Comparison of complications of both the groups
humeral shaft fractures following failed internal fixation and reported union in 23 patients [20]. They concluded that LCP is a reliable implant for achieving union and good functional outcome in humeral diaphyseal non-union. Nadkarni et al. have used LCP with bone grafting in two patients of non-union of humeral shaft fracture treated primarily with intramedullary nail. The nails were left in situ. Both cases achieved union with in 6 months [31]. In our study, we had achieved uneventful union in all the nonunion cases of LCP group, treated primarily with intramedullary nail but we had removed the implant during surgery. Kesemenli et al. retrospectively assessed 27 patients with humeral diaphyseal fracture non-union treated with interlocked nailing and autogenous bone grafting [21]. In their study, mean time to fracture union was 4.8 months (2.5–11 months) and union was achieved in all cases except one, similar to our study. In our study, in HIL group, average time to fracture union was nearly same (15.8 weeks, range 10.4–52 weeks). Corradi et al. reported results of treatment by Seidel locked nailing in 13 recent fractures and four non-unions of the humerus [19]. These four cases of non-unions were fractures treated primarily with Rush intramedullary nailing. All of the cases achieved consolidation and in 70 % of the patients results were
Complications
Group A
Group B
p value
Infection
2 (10 %)
3 (15 %)
0.64
Iatrogenic radial nerve palsy
0
2 (10 %)
0.31
Delayed union
0
1 (5 %)
0.48
Non-union
1 (5 %)
0
0.48
Implant failure
0
0
–
site due to narrow medullary canal above the olecranon fossa. In this study we have compared outcome scores and complications of non-union of humeral diaphyseal fractures treated with LCP and HIL. There was no significant difference found in terms of clinico-radiological outcomes and complications between both the groups. All the cases except one achieved union in our study. In LCP group, all the cases achieved union and results were comparable to other studies reported in the literature. Ring et al. reported 100 % union in all the 24 patients of non-union of humeral diaphysis fractures treated with LCP [16]. Kumar et al., in their prospective study, used LCP osteosynthesis and autologous bone grafting in 24 patients with non-union of
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excellent with complete recovery of range of movement of the shoulder. Pietu et al. reported five cases of non-unions of the humerus treated with locking nail. Union occurred in all cases [32]. Limbers et al. reviewed eight cases of nonunion of humeral shaft fractures treated with intramedullary nail union was achieved in seven patients [33]. Average range of motion of shoulder joint was nearly normal in all the cases except one case with antecedent advanced osteoarthrosis of the gleno-humeral joint. Other authors also achieved 100 % union rate in treatment of non-union humerus diaphyseal fractures using an interlocking nail [29, 34]. Wu et al. recommended plate osteosynthesis in non-unions of humerus shaft fractures treated primarily with intramedullary nailing [3]. In our study, all the cases in nailing group who had undergone intramedullary nailing primarily (4 cases as mentioned in Table 1) were treated with HIL and bone grafting and all the cases achieved uneventful union. There are various studies in the literature reporting that exchange nailing of humerus has not been as successful in treatment of non-union as in non-union of tibia or femur fractures, and absence of cyclical loading due to weight bearing and higher amount of distractive and torsional loads on the humerus were thought to be main reasons for this [35, 36]. Dujardin et al. reported failure in five out of 13 cases of humeral shaft non-union treated with locked intramedullary nail without bone grafting and similar results were reported by Thomsen et al. [2] who had five failures among 12 nonunions treated with the Seidel nail [37, 38]. The incidence of post-operative radial nerve injury in plate fixation is 0–5.6 % as reported in the literature [14]. In our study, in LCP group, two cases (10 %) had postoperative radial nerve palsy which can be attributed to fibrosis of surrounding tissues leading to difficulty in radial nerve exploration. Iatrogenic radial nerve palsy following primary treatment of diaphyseal fracture of humerus with interlocking nail has been reported in the literature [39] but there is no study reported in the literature regarding postoperative radial nerve palsy in non-union of humerus treated with interlocking nail. We have also not reported any palsy in nailing group. In various studies, intramedullary nailing has been reported to carry higher complication rates including persistent pain in the shoulder due to subacromial impingement and rotator cuff injury, iatrogenic fracture, shoulder and elbow stiffness, higher rates of delayed union and non-union [40–43]. In our study, at 2-year follow-up visit, there was no significant difference found between both the groups regarding average range of motion. No incidence of subacromial impingement, rotator cuff injury and iatrogenic fractures was reported in our study. The limitation of this study is small sample size from a single center hence significant conclusions could not be
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drawn. A larger randomized trial or a multi-center trial is needed to further improve the interpretation of the results and to establish the behavior of both the implants in treatment of humeral diaphyseal fracture non-union. Results of this study are comparable with the reported literatures [3, 16, 21] in terms of functional outcome and complication rates in both the groups. LCP fixation with bone grafting is an effective treatment option for non-union of fractures of humerus shaft. Our study concluded that interlocking nail fixation with bone grafting can also be used in humeral diaphyseal fracture non-union with comparable functional outcomes and acceptable complications. Conflict of interest
None.
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Arch Orthop Trauma Surg (2014) 134:947–953 15. Patel VR, Menon DK, Pool RD, Simonis RB (2000) Nonunion of the humerus after failure of surgical treatment management using the Ilizarov circular fixator. J Bone Joint Surg 82-B:977–983 16. Ring D, Kloen P, Kadzielski J, Helfet D, Jupiter JB (2004) Locking compression plates for osteoporotic nonunions of the diaphyseal humerus. Clin Orthop Relat Res 425:50–54 17. Manish Kiran M, Jee R (2010) Ilizarov’s method for treatment of nonunion of diaphyseal fractures of the humerus. Indian J Orthop 44(4):444–447 18. Bari MM, Ahmed MU, Hossain MB, Chowdhury FR, Siddiqui MA (2004) Treatment of non union of humerus using GA Ilizarov technique. Mymensingh Med J 13:36–38 19. Corradi M, Petriccioli D, Panno B, Marenghi P (1996) Seidel locked nailing for the treatment of unstable fractures and nonunion of the humerus. Chir Organi Mov 81(2):189–195 20. Kumar MN, Ravindranath VP, Ravishankar MR (2013) Outcome of locking compression plates in humeral shaft nonunions. Indian J Orthop 47(2):150–155 21. Kesemenli CC, Subasi M, Arslan H, Necmioglu S, Kapukaya A (2002) Treatment of humeral diaphyseal nonunions by interlocked nailing and autologous bone grafting. Acta Orthop Belg 68(5):471–475 22. Hudak PL, Amadio PC, Bombardier C (1996) Development of an upper extremity outcome measure: the DASH (disabilities of the arm, shoulder and hand) [corrected]. The Upper Extremity Collaborative Group (UECG). Am J Ind Med 29:602–608 23. Stewart MJ, Hundley JM (1955) Fractures of the humerus; a comparative study in methods of treatment. J Bone Joint Surg Am 37-A:681–692 24. Beguin JM, Plenevaux P, Poilvache G (1991) Considerations concerning the treatment of pseudarthrosis of the humerus. Acta Orthop Belg 57:114–123 25. Lee M (2005) Nonunions of the humerus. J Hand Ther 18(1):51–53 26. Chen CM, Chiu FY, Lo WH (2000) Treatment of acute closed humeral shaft fractures with Ender nails. Injury 31(9):683–685 27. Jupiter JB (1990) Complex non-union of the humeral diaphysis. Treatment with a medial approach, an anterior plate, and a vascularized fibular graft. J Bone Joint Surg Am 72(5):701–707 28. Bosh U, Skutek M, Kasperczyk WJ, Tscherme H (1999) Nonunion of the humeral diaphysis-operative and nonoperative treatment. Chirurg 70:1202–1208 29. Wu CC (1996) Humeral shaft nonunion treated by a Seidel interlocking nail with a supplementary staple. Clin Orthop 326:203–208 30. Billings A, Colemon SS (1999) Long-term follow-up of persistent humeral shaft nonunions treated with three-cortical bone grafting and compression plating. Iowa Orthop J 19:31–34
953 31. Nadkarni B, Srivastav S, Mittal V, Agarwal S (2008) Use of locking compression plates for long bone nonunions without removing existing intramedullary nail: review of literature and our experience. J Trauma 65:482–486 32. Pietu G, Raymond G, Letenneur J (1994) Treatment of delayed and nonunions of the humeral shaft using the Seidel locking nail: a preliminary report of five cases. J Orthop Trauma 8(3):240–244 33. Limbers J, Edmunds I, Ruff S (1998) Huckstep intramedullary nailing for non-union of humeral shaft fractures. Aust NZ J Surg 68:194–198 34. Ingman AM, Waters DA (1994) Locked intramedullary nailing of humeral shaft fractures: implant design, surgical technique, and clinical results. J Bone Joint Surg 76(1):23–29 35. McKee MD, Miranda MA, Reimer BL, Blasier RB, Redmond BJ, Sims SH et al (1996) Management of humeral nonunions after failure of intramedullary nails. J Orthop Trauma 10:492–499 36. Kempf I, Grosse A, Karger C (1990) Traitement des pseudarthroses aseptiques du fe´mur et du tibia par l’enclouage centrome´dullaire: apport du verrouillage. In:Cahier d’Enseignement de la SOFCOT, J. Duparc (ed) No 39: Enclouage centro-me´dullaire, sous le dir. de I Kempf. Expansion Scientifique Franc¸aise, Paris, p 91–96 37. Dujardin FH, Mazirt N, Tobenas AC, Duparc F, Thomine JM (2000) Failure of locked nailing for nonunion of the humeral shaft. Rev Chir Orthop 86:773–780 38. Thomsen NOB, Mikkelsen JB, Svendsen RN, Skovgaard N, Jensen CH, Jorgensen U (1998) Interlocking nailing of humeral shaft fractures. J Orthop Sci 3:199–203 39. Ajmal M, O’Sullivan M, McCabe J, Curtin W (2001) Antegrade locked intramedullary nailing in humeral shaft fractures. Injury 32:692–694 40. Bhandari M, Devereaux PJ, McKee MD, Schemitsch EH (2006) Compression plating versus intramedullary nailing of humeral shaft fractures—a meta-analysis. Acta Orthop 77(2):279–284 41. McCormack RG, Brien D, Buckley RE, McKee MD, Powell J, Schemitsch EH (2000) Fixation of fractures of the shaft of the humerus by dynamic compression plate or intramedullary nail: a prospective randomized trial. J Bone Joint Surg Br 82(3):336–339 42. Rodrı´guez-Mercha´n EC (1995) Compression plating versus Hackethal nailing in closed humeral shaft fractures failing nonoperative reduction. J Orthop Trauma 9(3):194–197 43. Brumback RJ, Bosse MJ, Poka A, Burgess AR (1986) Intramedullary stabilization of humeral shaft fractures in patients with multiple trauma. J Bone Joint Surg Am 68(7):960–970
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TRAUMA SURGERY
Treatment of non-union of humerus diaphyseal fractures: a prospective study comparing interlocking nail and locking compression plate Ashutosh Kumar Singh • G. R. Arun Nidhi Narsaria • Anurag Srivastava
•
Received: 22 October 2013 / Published online: 23 May 2014 Springer-Verlag Berlin Heidelberg 2014
Abstract Background The aim of this prospective comparative study was to compare outcomes and complications of humeral diaphyseal fracture non-unions managed with humerus interlocking nail (HIL) and locking compression plate (LCP). Materials and methods 40 patients with non-union of humeral diaphyseal fractures were included in this study and were randomly allocated in two groups; group A had 20 cases treated with HIL and group B had 20 cases treated with LCP. Clinico-radiological assessments were done for each case up to 2-year follow-up period. Primary outcome measures (time to fracture union, union rate) and secondary outcome measures (functional outcome and complication such as infection, malunion, delayed union, implant failure, joint stiffness and iatrogenic radial nerve palsy) were compared between both the groups. Disabilities of the arm, shoulder and hand (DASH) scoring and Steward and Hundley’s scoring system were used to assess functional outcome of the fracture fixation. Results There was no significant difference (p = 0.12) in terms of mean fracture union time between group A (15.8 ± 4.2 weeks) and group B (17.2 ± 3.8 weeks). Group A had 95 % union rate and group B had 100 %
A. K. Singh Department of Orthopedics, Mayo Institute of Medical Sciences, Barabanki, India G. R. Arun (&) Department of Orthopedics, Sri Mokambika Institute of Medical Sciences, Kanyakumari, India e-mail: [email protected] N. Narsaria A. Srivastava Mayo Institute of Medical Sciences, Barabanki, India
union rate (p = 0.14). At the 2-year follow-up visit, there was no significant difference found between both the groups regarding range of motion of shoulder and elbow joint. There was no significant difference found in final functional outcomes between both the groups on comparing DASH score (p = 0.14) and Steward and Hundley’s score (p = 0.08). In terms of complications, there was insignificant difference found between both the groups. Conclusions This study concludes that both the implants can be used in non-union of humeral shaft fractures with good functional outcomes and acceptable rate of complications. Keywords Humerus Locking compression plate Humerus interlocking nail Non-union Diaphyseal fractures Pseudoarthrosis
Introduction Fractures of the humeral shaft are relatively common and account for 3–5 % of all fractures [1]. 90–95 % of humerus fractures treated conservatively unite with good functional outcomes [2, 3]. Absolute indications for surgical fixation of humeral shaft fractures include fractures with neurovascular injury, open fractures, fractures with concomitant ipsilateral forearm fractures (floating elbow), patients with multiple injuries or polytrauma, progressive radial nerve deficits, pathologic fractures and failed non-operative management [4–6]. Relative indications include obese patients who do not tolerate brace and cast, patients with associated brachial plexus leading to inability to maintain bony alignment, and non-compliant patients [7, 8]. Following conservative or surgical treatment of humerus shaft fractures, 8–13 % nonunion rate has been reported [9, 10]. Non-union of humeral diaphyseal fractures, defined as a fracture with no evidence of
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radiological healing 6 months after injury, is a difficult problem to treat and might require multiple surgical procedures. Causes of humeral diaphyseal fracture non-unions are infection, distraction at fracture site, soft tissue interposition, unstable fixation, wrong choice of implant, iatrogenic devitalization of soft tissues, inadequate immobilization, open fractures, comminution and osteoporosis [11, 12]. Various devices used in treatment of humeral diaphyseal non-union are limited contact dynamic compression plates, locking compression plate (LCP), wave plates, humerus interlocking nail (HIL), Ilizarov external fixators and bone graft struts [13– 15]. Open reduction and internal fixation with plating is generally accepted as the best method of treatment for nonunion of fractures of the humerus in the adult with advantages of stable fixation, direct visualization, protection of the radial nerve, and sparing of the adjacent shoulder and elbow joint from injury and stiffness. LCP having features of compression and point bone–plate contact (minimum contact) is being used commonly for fixation of humeral shaft fractures non-union [16]. Circular external fixators have been used by many authors with acceptable outcomes [17, 18], but had certain disadvantages such as technical difficulty during fixator application, chances of neurovascular injury, restricted movement and pin-tract infections [14]. Intramedullary nail is also used in treatment of non-union of humerus fractures with advantage of being less invasive surgery, acts as a load sharing device, has less stress shielding and less chance of refracture after implant removal but distraction at fracture site, shoulder pain and stiffness is more common in nailing [19]. There are many clinical studies in the literature evaluating role of LCP [16, 19, 20] and HIL fixation [3, 21] in non-union of humerus shaft fractures and reported good functional outcome in both the methods. Our hypothesis states that the treatment of humeral diaphyseal fractures non-union with HIL and LCP would achieve comparable functional outcomes and acceptable complications. To the best of our knowledge, there is no study reporting comparison of LCP and HIL in treatment of non-union of humeral diaphyseal fractures. The aim of this study was to compare the clinico-radiological outcomes in terms of range of movements, radiological parameters, functional scores and complications in non-union of humerus diaphyseal fractures treated with LCP and HIL.
Materials and methods The protocol of this study was approved by the institutional review board. This study was authorized by the local ethical committee and was performed in accordance with the ethical standards of the 1964 Declaration of Helsinki as revised in 2000. Informed written consent was taken from all the patients. A power analysis, with a power of 80 % to
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detect DASH score difference of ten as being significant at the 5 % level, determined the sample size of 40 cases considering 10 to 15 % drop out rate during the follow-up. Each group required at least 20 cases. 40 patients with nonunion of diaphyseal fractures of humerus were included in this study as per inclusion criteria. The inclusion criteria were as follows: • •
Age [16 years and \65 years diaphyseal humerus fracture non-union following conservative or operative treatment The exclusion criteria were:
• • • • •
infective non-union associated medical complications for surgery associated nerve injury non-union of extraarticular fractures in the proximal and distal 5 cm of the humerus pathological fractures.
All the cases included in this study were randomized into two groups by sealed envelop method, patients treated with antegrade interlock nailing (group A) and those treated with 4.5 mm LCP (group B). Demographic profile of both the groups are shown in Table 1. In all the cases surgery was performed under general anesthesia by the same orthopedic surgeon, with the patient placed in the lateral decubitus position, using the posterior approach. In cases with implant in situ, implant was removed first then dissection was carried out down to the non-union site and radial nerve was identified. Both the proximal and distal fragment ends with intramedullary canal were then debrided of all soft tissue and resected back to bleeding bone. Culture was sent. In group A, antegrade interlock nailing (Synthes) was done. Proper reaming of the intramedullary canal of proximal and distal fragment of humerus was done (Fig. 1a, b). We made entry portal to the superolateral surface of the greater tuberosity below the supraspinatus insertion which minimized the risk of rotator cuff injury and adhesive capsulitis. In group B, 4.5 mm LCP (Synthes) was applied with at least eight points of cortical fixation on both sides of the non-union. In cases where plate had been used in primary surgery, LCP with 10–12 holes was used. Autogenous cancellous graft was harvested from iliac crest in all the cases and non-union of fracture site was filled with this graft. After irrigation the wound was closed in a routine fashion. In post-operative period, patients were immobilized in a sling, while active and active-assisted range of motion began as soon as tolerated, generally at third day. All patients were followed up at 1-month intervals for the first 6 months after the surgery, then at 2-month intervals for the next 6 months and then at 3-month interval for next 1 year after surgery. Antero-posterior (AP) and lateral
Arch Orthop Trauma Surg (2014) 134:947–953 Table 1 Demographic profile of study
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Characteristics
Group A (interlock nailing)
Group B (locking compression plate)
p value
Age in years, mean (range)
34.6 ± 7.8 years (17–64 years)
36.8 ± 9.2 years (20–65 years)
0.62
Sex (male:female)
12:8
13:7
0.44
Right:left
11:9
12:8
0.36
9
10
0.82
Type of primary treatment received Conservative Intramedullary nailing
4
3
0.78
Plating External fixation
5 2
4 3
0.80 0.64
Average time from fracture to treatment of the non-union
18.2 ± 4.2 months (10.2–26.6 months)
20.8 ± 4.6 months (11–28.2 months)
0.24
Fig. 1 a X-ray showing non-union of humeral diaphyseal fracture in 36-year-old male with implant in situ. b Removal of implant, freshening of fracture edges, internal fixation with antegrade
interlocking nail and autogenous iliac crest bone grafting was done. X-ray at 3-month follow-up visit showing well-uniting fracture. c Xray at 12-month follow-up visit showing united fracture
radiographs were taken at each follow-up visit. Shoulder and elbow range of motion was assessed at each follow-up visit. Fracture union time, complications and functional outcomes were also recorded. Each patient completed the disabilities of the arm, shoulder and hand (DASH) questionnaire during the follow-up [22]. The DASH questionnaire is a validated health status questionnaire that results in a score ranging from 0 points, representing no disability, to 100 points, representing maximum disability. All patients were also evaluated on the basis of Steward and Hundley’s scoring system (Table 2) which consists of scores of shoulder and elbow movements along with pain and angulation and has three categories of good, fair and poor outcomes [23]. The complications were evaluated in terms of infections (superficial or deep or chronic osteomyelitis), delayed union, non-union, implant failure, secondary loss
Table 2 Steward and Hundley’s scoring for evaluation of functional outcome Rating
Limitation of elbow or shoulder movement ()
Pain
Angulation ()
Good Fair
\20
None
\10
20–40
After efforts [10 or work
Poor
[40
Permanent
Radiological non-union
of reduction and implant breakage. Malunion was defined as healing occurring at more than 15 of angulation. A delayed union was diagnosed when no satisfactory signs of healing were present at 16-week followup visit. A non-union was diagnosed when no radiological signs of healing had occurred after 6 months.
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Student’s t test was used to analyze the difference of mean for different parameters. The test was referenced for two-tailed p value and 95 % confidence interval was constructed around sensitivity proportion using normal approximation method. Statistical analyses were performed using SPSS software. A value \0.05 was considered statistically significant.
Arch Orthop Trauma Surg (2014) 134:947–953 Table 3 Comparison of functional scores between both the groups Functional scores
Group A
Group B
DASH score (mean ± SD)
12.8 ? 8.2
10.4 ? 10.4
Good
12
14
Fair
07
06
Poor
01
0
Steward and Hundley’s scoring
Results The average age in the group A was 34.6 ± 7.8 years (range 17–64 years) and in group B was 36.8 ± 9.2 years (range 20–65 years). Both groups showed no statistical difference in term of age (p = 0.62), gender (p = 0.44), affected side (p = 0.36) and time from injury to treatment for non-union (p = 0.24). In group A, 11 cases had implant used in primary fracture fixation including DCP, Enders nail, Rush nail, Kuntscher nail and tubular external fixator while in group B, ten cases had implant used in primary fracture fixation. Implant failure was obvious on the preoperative radiographs in 15 patients. 19 cases included in this study were treated conservatively primarily with plaster or brace. All the patients were followed for 2 years after surgery. The average time from injury to treatment of non-union in group A was 18.2 ± 4.2 months (10.2–26.6 months) and in group B, was 20.8 ± 4.6 months (11–28.2 months) and there was no statistical significance found between the two groups (p = 0.24). The mean fracture union time was 15.8 ± 4.2 weeks (range 10.4–52 weeks) in group A and 17.2 ± 3.8 weeks (range 12–46 weeks) in group B and there was no statistically significant difference found between the two groups (p = 0.12). Group A had 95 % union rate and group B had 100 % union rate (p = 0.14); (Fig. 1c, d). The average DASH score in group A (12.8 ± 8.2) was more than group B (10.4 ± 10.4) but there was no significant difference found (p = 0.14). According to Steward and Hundley’s scoring system, 12 cases had good functional outcome, seven cases had fair outcome and one case had poor outcome in group A while in group B, 14 cases had good outcome and six cases had fair outcome (Table 3). There was no significant difference found in terms of functional outcome of both the groups (p = 0.08). At the 24-month follow-up visit, there was no significant difference found regarding range of motion of shoulder and elbow joint of both the groups. Two patients (10 %) in group A and three patients (15 %) in group B had superficial infection (p = 0.64), which subsided uneventfully following antibiotic therapy. There was no incidence of deep infection in either group. The radial nerve was identified in all the cases during
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freshening of fracture edges. Iatrogenic radial nerve palsy was reported only in group B (10 %) and there was no significant difference found (p = 0.31) between both the groups. Both case of iatrogenic radial nerve palsies in group B spontaneously recovered with conservative treatment within 6 months. One case (5 %) had delayed union in group A which was treated conservatively and the fracture achieved solid union in 13 months after surgery. One case (5 %) in group A had non-union which was treated with nail removal, freshening of edges and LCP fixation with autologous iliac crest bone grafting and fracture achieved union uneventfully (Fig. 2a–d). There was no incidence of implant failure and implant removal was not done in any case of both groups up to 2-year follow-up visit (Table 4).
Discussion Humeral shaft fractures have a high rate of union whether treated conservatively or surgically. Non-union has been reported to occur in 8–12 % of all humeral shaft fractures [9]. Non-union rates between 0–13 % are reported for humeral diaphyseal fractures treated non-operatively [9, 25]. Some authors have reported still higher rate of nonunion in humeral shaft fractures treated surgically for appropriate indications (non-union rate up to 15–25 %) [24–26]. Management of non-union of the humeral shaft is a difficult problem. Conservative methods used in these non-union cases include casting, functional bracing, splints, electric stimulation and extracorporeal shock waves [14, 27, 28]. These methods have not been seen to be very useful and can be used only in selected cases. Surgical methods include compression plating, intramedullary exchange nailing, strut bone grafting and Ilizarov external fixator [15, 29, 30]. Freshening of fracture edges, plate fixation and cortico-cancellous bone grafting have been accepted as standard surgical treatment. Locked intramedullary nailing has been also used with advantages of need of less soft tissue dissection, less rate of infection and less chances of nerve injury [21] but nailing had been shown to be associated with some disadvantages like lack of compression at fracture site and distraction at fracture
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Fig. 2 a X-ray showing non-union of humeral diaphyseal fracture in 30-year-old female with implant in situ. b X-ray lateral view showing non-union in same case. c Removal of implant, freshening of fracture edges, internal fixation with antegrade interlocking nail and
autogenous iliac crest bone grafting was done. X-ray at 15-month follow-up visit showing non-union of fracture. d Revision surgery (removal of nail, freshening of fracture edges, internal fixation with LCP and autogenous iliac crest bone grafting) done
Table 4 Comparison of complications of both the groups
humeral shaft fractures following failed internal fixation and reported union in 23 patients [20]. They concluded that LCP is a reliable implant for achieving union and good functional outcome in humeral diaphyseal non-union. Nadkarni et al. have used LCP with bone grafting in two patients of non-union of humeral shaft fracture treated primarily with intramedullary nail. The nails were left in situ. Both cases achieved union with in 6 months [31]. In our study, we had achieved uneventful union in all the nonunion cases of LCP group, treated primarily with intramedullary nail but we had removed the implant during surgery. Kesemenli et al. retrospectively assessed 27 patients with humeral diaphyseal fracture non-union treated with interlocked nailing and autogenous bone grafting [21]. In their study, mean time to fracture union was 4.8 months (2.5–11 months) and union was achieved in all cases except one, similar to our study. In our study, in HIL group, average time to fracture union was nearly same (15.8 weeks, range 10.4–52 weeks). Corradi et al. reported results of treatment by Seidel locked nailing in 13 recent fractures and four non-unions of the humerus [19]. These four cases of non-unions were fractures treated primarily with Rush intramedullary nailing. All of the cases achieved consolidation and in 70 % of the patients results were
Complications
Group A
Group B
p value
Infection
2 (10 %)
3 (15 %)
0.64
Iatrogenic radial nerve palsy
0
2 (10 %)
0.31
Delayed union
0
1 (5 %)
0.48
Non-union
1 (5 %)
0
0.48
Implant failure
0
0
–
site due to narrow medullary canal above the olecranon fossa. In this study we have compared outcome scores and complications of non-union of humeral diaphyseal fractures treated with LCP and HIL. There was no significant difference found in terms of clinico-radiological outcomes and complications between both the groups. All the cases except one achieved union in our study. In LCP group, all the cases achieved union and results were comparable to other studies reported in the literature. Ring et al. reported 100 % union in all the 24 patients of non-union of humeral diaphysis fractures treated with LCP [16]. Kumar et al., in their prospective study, used LCP osteosynthesis and autologous bone grafting in 24 patients with non-union of
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excellent with complete recovery of range of movement of the shoulder. Pietu et al. reported five cases of non-unions of the humerus treated with locking nail. Union occurred in all cases [32]. Limbers et al. reviewed eight cases of nonunion of humeral shaft fractures treated with intramedullary nail union was achieved in seven patients [33]. Average range of motion of shoulder joint was nearly normal in all the cases except one case with antecedent advanced osteoarthrosis of the gleno-humeral joint. Other authors also achieved 100 % union rate in treatment of non-union humerus diaphyseal fractures using an interlocking nail [29, 34]. Wu et al. recommended plate osteosynthesis in non-unions of humerus shaft fractures treated primarily with intramedullary nailing [3]. In our study, all the cases in nailing group who had undergone intramedullary nailing primarily (4 cases as mentioned in Table 1) were treated with HIL and bone grafting and all the cases achieved uneventful union. There are various studies in the literature reporting that exchange nailing of humerus has not been as successful in treatment of non-union as in non-union of tibia or femur fractures, and absence of cyclical loading due to weight bearing and higher amount of distractive and torsional loads on the humerus were thought to be main reasons for this [35, 36]. Dujardin et al. reported failure in five out of 13 cases of humeral shaft non-union treated with locked intramedullary nail without bone grafting and similar results were reported by Thomsen et al. [2] who had five failures among 12 nonunions treated with the Seidel nail [37, 38]. The incidence of post-operative radial nerve injury in plate fixation is 0–5.6 % as reported in the literature [14]. In our study, in LCP group, two cases (10 %) had postoperative radial nerve palsy which can be attributed to fibrosis of surrounding tissues leading to difficulty in radial nerve exploration. Iatrogenic radial nerve palsy following primary treatment of diaphyseal fracture of humerus with interlocking nail has been reported in the literature [39] but there is no study reported in the literature regarding postoperative radial nerve palsy in non-union of humerus treated with interlocking nail. We have also not reported any palsy in nailing group. In various studies, intramedullary nailing has been reported to carry higher complication rates including persistent pain in the shoulder due to subacromial impingement and rotator cuff injury, iatrogenic fracture, shoulder and elbow stiffness, higher rates of delayed union and non-union [40–43]. In our study, at 2-year follow-up visit, there was no significant difference found between both the groups regarding average range of motion. No incidence of subacromial impingement, rotator cuff injury and iatrogenic fractures was reported in our study. The limitation of this study is small sample size from a single center hence significant conclusions could not be
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drawn. A larger randomized trial or a multi-center trial is needed to further improve the interpretation of the results and to establish the behavior of both the implants in treatment of humeral diaphyseal fracture non-union. Results of this study are comparable with the reported literatures [3, 16, 21] in terms of functional outcome and complication rates in both the groups. LCP fixation with bone grafting is an effective treatment option for non-union of fractures of humerus shaft. Our study concluded that interlocking nail fixation with bone grafting can also be used in humeral diaphyseal fracture non-union with comparable functional outcomes and acceptable complications. Conflict of interest
None.
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