Arch Orthop Trauma Surg DOI 10.1007/s00402-014-2142-1
TRAUMA SURGERY
Comparison of novel intramedullary nailing with mini-invasive plating in surgical fixation of displaced midshaft clavicle fractures Sinan Zehir • Regayip Zehir • Ercan S¸ ahin Murat C ¸ albıyık
•
Received: 15 September 2014 Ó Springer-Verlag Berlin Heidelberg 2014
Abstract Introduction This prospective randomized pilot study sought to determine whether fixation with Sonoma CRx intramedullary pin is a comparable alternative to minimally invasive plating fixation in patients with displaced clavicle fractures. Materials and methods A total of 45 consecutive patients (Robinson class B1 or B2) were randomly allocated into two groups; intramedullary pin (IMP) group (n = 24, mean age; 33.17 ± 8.60 years, 14 males 58.3 %) received Sonoma CRx Collarbone pin (Sonoma, USA) whereas locking midshaft superior plating (MIPPO) group (n = 21, 32.38 ± 8.41 years, 12 males) patients received minimally invasive locking midshaft superior plating (Acumed, USA). Patients were followed up with a mean time of 11.82 ± 4.22 and 14.45 ± 6.43 months, respectively. Functional status, as the primary outcome measure, was assessed using quick disability of the arm, shoulder and hand (DASH) scores. Results Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group (p \ 0.001 and p = 0.03, respectively). Time of hospital stay was significantly shorter in S. Zehir (&) M. C¸albıyık Department of Orthopedics and Traumatology, Faculty of Medicine, Hitit University, C¸amlık Street No: 2, Bahc¸elievler District, C¸orum, Turkey e-mail: [email protected] R. Zehir Carsamba State Hospital, Samsun, Turkey E. S¸ ahin Department of Orthopedics and Traumatology, Faculty of Medicine, Bu¨lent Ecevit University, Esenko¨y-Kozlu, Zonguldak, Turkey
IMP group (p \ 0.001). Complications were rare in the early postoperative period. Time until bony union was significantly shorter in IMP group. Mean quick DASH scores were not significantly different between two groups. Implant failure occurred in one patient from each group. Cosmetic dissatisfaction was more common in MIPPO group. Conclusion Given the shorter operative times and better cosmetic appearance, Sonoma CRx intramedullary pin may be an alternative to minimally invasive plating. Further safety studies are warranted. Keywords Clavicle midshaft fractures Intramedullary pin MIPPO Operative treatment
Introduction Fractures of the clavicle constitute 2.6–10.7 % of all fractures with the incidence being higher among severely injured patients. Clavicle fractures are common in young men; vehicle accident was reported to be the most common mechanism of injury and the incidence gradually decreases with increasing age. Fractures of the mid-clavicle account for more than half of all clavicle fractures whereas the fracture pattern was reported to be displaced in 48 % and comminuted in 19 % of all cases [1, 2]. Midshaft fractures of the clavicle are treated conservatively since most patients achieve union without need for further intervention, especially if the fracture is not severely displaced. There has been limited evidence to establish the effectiveness of surgical treatment when compared to non-operative treatment [3]. However, it is known that a displaced fracture or shortened clavicle possess risk for development of malunion which may occur up
123
Arch Orthop Trauma Surg
to 30 % of patients after non-operative treatment and may cause a painful shoulder. Occurrence of malunion may cause muscle atrophy or clavicle shortening leading to functional impairment in daily activities. Operative treatment is the only option to prevent malunion in patients having severely displaced acute midshaft clavicle fractures [4, 5]. Currently, plate osteosynthesis and intramedullary pin (IMP) insertion are two most common fixation techniques for treatment of displaced or comminuted clavicle fractures. In biomechanical tests, both techniques showed adequate stability while plate constructs were found to be less displaced after application of greater loads when compared to intramedullary devices, indicating a potential benefit in resisting against postoperative rehabilitation protocol [6, 7]. These observations regarding plate fixation versus IMP insertion were partly translated into clinical outcomes in several comparative studies where no substantial differences were found between two techniques with regard to clinical outcomes but plating was found to be associated with more side effects [8, 9]. Device displacement and tissue irritation are of major concern using IMP implantation in clavicle midshaft fractures. Sonoma CRx is a new intramedullary device featuring a combined flexible-rigid body and medially actuating talons which were developed for the purpose of providing better stability and preventing torsion. Also, its flexible distal tip transforms from flexible to rigid after implantation and thus the implant conforms and maintains the natural shape of the clavicle. To our knowledge, there has been only one clinical study [10] reporting outcomes using this device, but a comparative study has not yet been reported. This pilot study sought to determine whether use of Sonoma CRx IMP is a comparable alternative to minimally invasive locking midshaft superior plating (MIPPO LMSP AcumedÒ).
factor for pain, strength reduction and malunion after clavicle fractures [13]. Patients with open comminuted fractures and those having multiple trauma, poor hemodynamic status, neurovascular injury, rib fractures or any other morbidities at the ipsilateral side were excluded. Patients were randomly allocated into two groups (IMP group and MIPPO group) using a computer-based random number generator in blocks of two, ensuring a near equal distribution of patients into treatment arms. Group allocation of patients was performed using sealed envelopes. In IMP group (n = 24, mean age; 33.17 ± 8.60 years, 14 males 58.3 %), patients received Sonoma Crx Collarbone pin (Sonoma, USA) whereas MIPPO group (n = 21, 32.38 ± 8.41 years, 12 males) patients received minimally invasive locking midshaft superior plating (MIPPO LMSP AcumedÒ, USA). All operations were performed by one of the two surgeons who had performed at least 10 procedures using each technique. Surgical technique All operations were performed under general anesthesia and all patients received 2 g intravenous cefazolin 30 min before the skin incision was made. Patients were placed in the beach chair position. In both groups, specific instructions of the manufacturers were followed for each device. The technique we used for implantation of the Sonoma CRx device (IMP group) was similar to that of described previously by King et al. [10] (Fig. 1). Whereas implanting locking midshaft superior plate (MIPPO group), we used the minimal invasive technique that was recently described by Jiang et al. [14]. Thus, a 3–4 cm skin incision was sufficient in both groups and left similar sized scars, ensuring observer blinding during survey interview (Fig. 2). Sonoma CRx implants used in this study were 100–120 mm in length and 4.2 mm in diameter whereas
Materials and methods The study was approved by local ethics committee. All patients were informed about the study procedure and gave consent to take part in the research. This prospective randomized pilot study was undertaken in a tertiary university hospital and patient enrollment occurred from November 2010 through August 2013. Between these dates, a total of 76 patients presented with closed displaced midshaft fractures. A total of 45 consecutive patients who were between 18 and 55 years age, having Robinson Type 2 B1 or B2 clavicle fractures [11] with [20 mm clavicle shortening [12] and presented within 2 weeks after the injury were considered eligible. Patients over the age of 55 were not included because older age has been established to be a risk
123
Fig. 1 X-ray image of intramedullary pin application
Arch Orthop Trauma Surg
Fig. 2 View of the skin incision during MIPPO application
locking midshaft superior plate (LMSP) were used in six different lengths and curvatures in both left and right. Patients with comminuted fractures (Robinson Type 2B2, 5 patients in each group), received a concomitant autogenous iliac bone grafting to ensure stability. Postoperative care and follow-up All patients were given arm slings for about 2 weeks after the operation. Early mobilization and active shoulder range of motion exercises were encouraged. Patients were allowed to resume their daily activities and weight bearing about 4 weeks after the operation. Patients were invited to follow-up visit at 1st month and every 3 months after the operation. Radiographic assessment was made at each visit and bone union was assessed based on callus formation. Patients were questioned on cosmetic satisfaction, pain lying on the affected site and functional status, as the primary outcome measure, was assessed using Quick Disability of the Arm, Shoulder and Hand (DASH) scores [15]. Statistical analysis All statistical analyses were performed using SPSS (SPSS version 16.0 Inc. Chicago, IL. USA) packaged software. Histograms and analytical methods (Shapiro–Wilk’s test) were used for determination of normal distribution. Continuous data were defined as mean ± standard deviations. Parametric data were compared using independent sample t test and non-parametric data were compared using Mann– Whitney test. Categorical data were compared using Chi square test or Fisher’s exact test where appropriate. A p value of less than 0.05 was considered to be statistically significant. An a priori sample size calculation was performed based on data from the study by Cho et al. [16] on patients receiving either standard reconstruction plate or locking compression plate. In this study, as an outcome measure, mean (min–max) quick DASH score in locking compression plate group was not significantly different from that in standard treatment group and reported to be 34.81 (22.7–81.8). Assuming a 30 % difference in quick DASH scores, with a significance level of a = 0.05, and b = 0.10,
we found that 21 subjects were required in each group. Initial randomization using blocks-in-two methods was based on 21 patients in each block. Patient enrollment continued until the total number slightly exceeded this limit as protocol breaches and dropouts were taken into account. Group allocation was decided upon heads or tails method in last three patients. This pilot study was not adequately powered to detect significant differences in clinical outcomes including complications and implant failure rates.
Results Baseline characteristics are given in Table 1. Two groups were similar with regard to age, distribution of gender, fracture types and injury. Time from injury to operation was also similar between two groups. Twenty patients were operated on for right-sided injury and 25 patients for leftsided injury. Postoperative outcomes are given in Table 2. Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group (p \ 0.001 and p = 0.03, respectively). Time of hospital stay was significantly shorter in IMP group (p \ 0.001). Complications were rare in the early postoperative period. None of the patients had hematoma, bleeding or severe pain that affect early mobilization. One patient in MIPPO group had wound infection and discharge that improved with oral antibiotics and wound care. Follow-up ranged from 1 to 38 months; patients in IMP and MIPPO groups were followed up for a mean time of 11.82 ± 4.22 and 14.45 ± 6.43 months, respectively (p = 0.10). Follow-up information including quick DASH scores, complications and radiographic bony union time were available in all patients. Follow-up time was shorter than 3 months in 3 patients and, therefore, radiographic bony union time was recorded as zero in these patients. At least 1-year follow-up was achieved in 19 of 24 patients (79.2 %) in IMP group and 15 of 21 (71.4 %) in MIPPO group. Time until bony union was significantly shorter in IMP group than that in MIPPO group whereas mean quick DASH scores were not significantly different between two groups. Complications were rare; implant failure occurred in one patient from each group both due to excessive physiological loading. In patient in the IMP group, we observed that implant failure occurred because flexible part of the implant had not been passed beyond the fragmented segment during implantation and the implant was broken just at the junction of rigid and flexible parts. In the other patient, MIPPO was found slightly eluded from the bone shaft that was due to loosening of the plate screws. Because there was no significant clavicle shortening, none of these patients underwent revision for surgery.
123
Arch Orthop Trauma Surg Table 1 Baseline characteristics
Variable
Intramedullary pina (n = 24)
MIPPOb (n = 21)
p
Age
33.17 ± 8.60
32.38 ± 8.41
0.75
Males
14 (58.3 %)
12 (57.1 %)
0.93
Mechanism of injury
a
Sonoma Crx Collarbone pin (Sonoma, USA)
b
Minimally invasive percutaneous plate osteosynthesis (LMSP Acumed USAÒ)
Table 2 Operative results and treatment outcomes
Fall
14 (58.3 %)
14 (66.7 %)
0.65
Vehicle accident
4 (16.7 %)
3 (14.3 %)
0.82
Sports injury
5 (20.8 %)
3 (14.3 %)
0.70
Assault
1 (4.2 %)
1 (4.8 %)
0.72
Type of fractures Type B1
19 (79.2 %)
16 (76.2 %)
0.81
Type B2
5 (20.8 %)
5 (23.8 %)
0.81
5.7 (2–15)
6.2 (2–15)
0.62
Time from injury to operation(day)
Variable
Intramedullary pina (n = 24)
MIPPOb (n = 21)
p
TRAUMA SURGERY
Comparison of novel intramedullary nailing with mini-invasive plating in surgical fixation of displaced midshaft clavicle fractures Sinan Zehir • Regayip Zehir • Ercan S¸ ahin Murat C ¸ albıyık
•
Received: 15 September 2014 Ó Springer-Verlag Berlin Heidelberg 2014
Abstract Introduction This prospective randomized pilot study sought to determine whether fixation with Sonoma CRx intramedullary pin is a comparable alternative to minimally invasive plating fixation in patients with displaced clavicle fractures. Materials and methods A total of 45 consecutive patients (Robinson class B1 or B2) were randomly allocated into two groups; intramedullary pin (IMP) group (n = 24, mean age; 33.17 ± 8.60 years, 14 males 58.3 %) received Sonoma CRx Collarbone pin (Sonoma, USA) whereas locking midshaft superior plating (MIPPO) group (n = 21, 32.38 ± 8.41 years, 12 males) patients received minimally invasive locking midshaft superior plating (Acumed, USA). Patients were followed up with a mean time of 11.82 ± 4.22 and 14.45 ± 6.43 months, respectively. Functional status, as the primary outcome measure, was assessed using quick disability of the arm, shoulder and hand (DASH) scores. Results Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group (p \ 0.001 and p = 0.03, respectively). Time of hospital stay was significantly shorter in S. Zehir (&) M. C¸albıyık Department of Orthopedics and Traumatology, Faculty of Medicine, Hitit University, C¸amlık Street No: 2, Bahc¸elievler District, C¸orum, Turkey e-mail: [email protected] R. Zehir Carsamba State Hospital, Samsun, Turkey E. S¸ ahin Department of Orthopedics and Traumatology, Faculty of Medicine, Bu¨lent Ecevit University, Esenko¨y-Kozlu, Zonguldak, Turkey
IMP group (p \ 0.001). Complications were rare in the early postoperative period. Time until bony union was significantly shorter in IMP group. Mean quick DASH scores were not significantly different between two groups. Implant failure occurred in one patient from each group. Cosmetic dissatisfaction was more common in MIPPO group. Conclusion Given the shorter operative times and better cosmetic appearance, Sonoma CRx intramedullary pin may be an alternative to minimally invasive plating. Further safety studies are warranted. Keywords Clavicle midshaft fractures Intramedullary pin MIPPO Operative treatment
Introduction Fractures of the clavicle constitute 2.6–10.7 % of all fractures with the incidence being higher among severely injured patients. Clavicle fractures are common in young men; vehicle accident was reported to be the most common mechanism of injury and the incidence gradually decreases with increasing age. Fractures of the mid-clavicle account for more than half of all clavicle fractures whereas the fracture pattern was reported to be displaced in 48 % and comminuted in 19 % of all cases [1, 2]. Midshaft fractures of the clavicle are treated conservatively since most patients achieve union without need for further intervention, especially if the fracture is not severely displaced. There has been limited evidence to establish the effectiveness of surgical treatment when compared to non-operative treatment [3]. However, it is known that a displaced fracture or shortened clavicle possess risk for development of malunion which may occur up
123
Arch Orthop Trauma Surg
to 30 % of patients after non-operative treatment and may cause a painful shoulder. Occurrence of malunion may cause muscle atrophy or clavicle shortening leading to functional impairment in daily activities. Operative treatment is the only option to prevent malunion in patients having severely displaced acute midshaft clavicle fractures [4, 5]. Currently, plate osteosynthesis and intramedullary pin (IMP) insertion are two most common fixation techniques for treatment of displaced or comminuted clavicle fractures. In biomechanical tests, both techniques showed adequate stability while plate constructs were found to be less displaced after application of greater loads when compared to intramedullary devices, indicating a potential benefit in resisting against postoperative rehabilitation protocol [6, 7]. These observations regarding plate fixation versus IMP insertion were partly translated into clinical outcomes in several comparative studies where no substantial differences were found between two techniques with regard to clinical outcomes but plating was found to be associated with more side effects [8, 9]. Device displacement and tissue irritation are of major concern using IMP implantation in clavicle midshaft fractures. Sonoma CRx is a new intramedullary device featuring a combined flexible-rigid body and medially actuating talons which were developed for the purpose of providing better stability and preventing torsion. Also, its flexible distal tip transforms from flexible to rigid after implantation and thus the implant conforms and maintains the natural shape of the clavicle. To our knowledge, there has been only one clinical study [10] reporting outcomes using this device, but a comparative study has not yet been reported. This pilot study sought to determine whether use of Sonoma CRx IMP is a comparable alternative to minimally invasive locking midshaft superior plating (MIPPO LMSP AcumedÒ).
factor for pain, strength reduction and malunion after clavicle fractures [13]. Patients with open comminuted fractures and those having multiple trauma, poor hemodynamic status, neurovascular injury, rib fractures or any other morbidities at the ipsilateral side were excluded. Patients were randomly allocated into two groups (IMP group and MIPPO group) using a computer-based random number generator in blocks of two, ensuring a near equal distribution of patients into treatment arms. Group allocation of patients was performed using sealed envelopes. In IMP group (n = 24, mean age; 33.17 ± 8.60 years, 14 males 58.3 %), patients received Sonoma Crx Collarbone pin (Sonoma, USA) whereas MIPPO group (n = 21, 32.38 ± 8.41 years, 12 males) patients received minimally invasive locking midshaft superior plating (MIPPO LMSP AcumedÒ, USA). All operations were performed by one of the two surgeons who had performed at least 10 procedures using each technique. Surgical technique All operations were performed under general anesthesia and all patients received 2 g intravenous cefazolin 30 min before the skin incision was made. Patients were placed in the beach chair position. In both groups, specific instructions of the manufacturers were followed for each device. The technique we used for implantation of the Sonoma CRx device (IMP group) was similar to that of described previously by King et al. [10] (Fig. 1). Whereas implanting locking midshaft superior plate (MIPPO group), we used the minimal invasive technique that was recently described by Jiang et al. [14]. Thus, a 3–4 cm skin incision was sufficient in both groups and left similar sized scars, ensuring observer blinding during survey interview (Fig. 2). Sonoma CRx implants used in this study were 100–120 mm in length and 4.2 mm in diameter whereas
Materials and methods The study was approved by local ethics committee. All patients were informed about the study procedure and gave consent to take part in the research. This prospective randomized pilot study was undertaken in a tertiary university hospital and patient enrollment occurred from November 2010 through August 2013. Between these dates, a total of 76 patients presented with closed displaced midshaft fractures. A total of 45 consecutive patients who were between 18 and 55 years age, having Robinson Type 2 B1 or B2 clavicle fractures [11] with [20 mm clavicle shortening [12] and presented within 2 weeks after the injury were considered eligible. Patients over the age of 55 were not included because older age has been established to be a risk
123
Fig. 1 X-ray image of intramedullary pin application
Arch Orthop Trauma Surg
Fig. 2 View of the skin incision during MIPPO application
locking midshaft superior plate (LMSP) were used in six different lengths and curvatures in both left and right. Patients with comminuted fractures (Robinson Type 2B2, 5 patients in each group), received a concomitant autogenous iliac bone grafting to ensure stability. Postoperative care and follow-up All patients were given arm slings for about 2 weeks after the operation. Early mobilization and active shoulder range of motion exercises were encouraged. Patients were allowed to resume their daily activities and weight bearing about 4 weeks after the operation. Patients were invited to follow-up visit at 1st month and every 3 months after the operation. Radiographic assessment was made at each visit and bone union was assessed based on callus formation. Patients were questioned on cosmetic satisfaction, pain lying on the affected site and functional status, as the primary outcome measure, was assessed using Quick Disability of the Arm, Shoulder and Hand (DASH) scores [15]. Statistical analysis All statistical analyses were performed using SPSS (SPSS version 16.0 Inc. Chicago, IL. USA) packaged software. Histograms and analytical methods (Shapiro–Wilk’s test) were used for determination of normal distribution. Continuous data were defined as mean ± standard deviations. Parametric data were compared using independent sample t test and non-parametric data were compared using Mann– Whitney test. Categorical data were compared using Chi square test or Fisher’s exact test where appropriate. A p value of less than 0.05 was considered to be statistically significant. An a priori sample size calculation was performed based on data from the study by Cho et al. [16] on patients receiving either standard reconstruction plate or locking compression plate. In this study, as an outcome measure, mean (min–max) quick DASH score in locking compression plate group was not significantly different from that in standard treatment group and reported to be 34.81 (22.7–81.8). Assuming a 30 % difference in quick DASH scores, with a significance level of a = 0.05, and b = 0.10,
we found that 21 subjects were required in each group. Initial randomization using blocks-in-two methods was based on 21 patients in each block. Patient enrollment continued until the total number slightly exceeded this limit as protocol breaches and dropouts were taken into account. Group allocation was decided upon heads or tails method in last three patients. This pilot study was not adequately powered to detect significant differences in clinical outcomes including complications and implant failure rates.
Results Baseline characteristics are given in Table 1. Two groups were similar with regard to age, distribution of gender, fracture types and injury. Time from injury to operation was also similar between two groups. Twenty patients were operated on for right-sided injury and 25 patients for leftsided injury. Postoperative outcomes are given in Table 2. Mean time of operation and mean time of fluoroscopy were significantly shorter in the IMP group than those in MIPPO group (p \ 0.001 and p = 0.03, respectively). Time of hospital stay was significantly shorter in IMP group (p \ 0.001). Complications were rare in the early postoperative period. None of the patients had hematoma, bleeding or severe pain that affect early mobilization. One patient in MIPPO group had wound infection and discharge that improved with oral antibiotics and wound care. Follow-up ranged from 1 to 38 months; patients in IMP and MIPPO groups were followed up for a mean time of 11.82 ± 4.22 and 14.45 ± 6.43 months, respectively (p = 0.10). Follow-up information including quick DASH scores, complications and radiographic bony union time were available in all patients. Follow-up time was shorter than 3 months in 3 patients and, therefore, radiographic bony union time was recorded as zero in these patients. At least 1-year follow-up was achieved in 19 of 24 patients (79.2 %) in IMP group and 15 of 21 (71.4 %) in MIPPO group. Time until bony union was significantly shorter in IMP group than that in MIPPO group whereas mean quick DASH scores were not significantly different between two groups. Complications were rare; implant failure occurred in one patient from each group both due to excessive physiological loading. In patient in the IMP group, we observed that implant failure occurred because flexible part of the implant had not been passed beyond the fragmented segment during implantation and the implant was broken just at the junction of rigid and flexible parts. In the other patient, MIPPO was found slightly eluded from the bone shaft that was due to loosening of the plate screws. Because there was no significant clavicle shortening, none of these patients underwent revision for surgery.
123
Arch Orthop Trauma Surg Table 1 Baseline characteristics
Variable
Intramedullary pina (n = 24)
MIPPOb (n = 21)
p
Age
33.17 ± 8.60
32.38 ± 8.41
0.75
Males
14 (58.3 %)
12 (57.1 %)
0.93
Mechanism of injury
a
Sonoma Crx Collarbone pin (Sonoma, USA)
b
Minimally invasive percutaneous plate osteosynthesis (LMSP Acumed USAÒ)
Table 2 Operative results and treatment outcomes
Fall
14 (58.3 %)
14 (66.7 %)
0.65
Vehicle accident
4 (16.7 %)
3 (14.3 %)
0.82
Sports injury
5 (20.8 %)
3 (14.3 %)
0.70
Assault
1 (4.2 %)
1 (4.8 %)
0.72
Type of fractures Type B1
19 (79.2 %)
16 (76.2 %)
0.81
Type B2
5 (20.8 %)
5 (23.8 %)
0.81
5.7 (2–15)
6.2 (2–15)
0.62
Time from injury to operation(day)
Variable
Intramedullary pina (n = 24)
MIPPOb (n = 21)
p
