 TRAUMA

Hemiarthroplasty versus internal fixation for displaced intracapsular fractures of the hip in elderly men A PILOT RANDOMISED TRIAL M. J. Parker From Peterborough City Hospital, Peterborough, United Kingdom

A total of 56 male patients with a displaced intracapsular fracture of the hip and a mean age of 81 years (62 to 94), were randomised to be treated with either a cemented hemiarthroplasty (the Exeter Trauma Stem) or reduction and internal fixation using the Targon Femoral Plate. All surviving patients were reviewed one year after the injury, at which time restoration of function and pain in the hip was assessed. There was no statistically significant difference in mortality between the two groups (7/26; 26.9% for hemiarthroplasty vs 10/30; 33.3% for internal fixation). No patient treated with a hemiarthroplasty required further surgery, but eight patients treated by internal fixation did (p = 0.005), five requiring hemiarthroplasty and three requiring total hip arthroplasty. Those treated by internal fixation had significantly more pain (p = 0.02). The restoration of mobility and independence were similar in the two groups. These results indicate that cemented hemiarthroplasty gives better results than internal fixation in elderly men with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2015;97-B:992–6.

 M. J. Parker, MD, FRCS(Edinb), Consultant Orthopaedic Surgeon Peterborough City Hospital, Bretton gate, Peterborough PE3 9GZ, UK. Correspondence should be sent to Mr M. J. Parker; e-mail: [email protected] ©2015 The British Editorial Society of Bone & Joint Surgery doi:10.1302/0301-620X.97B7. 35524 $2.00 Bone Joint J 2015;97-B:992–6. Received 25 November 2014; Accepted after revision 16 February 2015

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Displaced intracapsular fractures of the hip in the elderly are usually treated by replacement arthroplasty owing to the high risk of impaired healing.1-4 Rates of re-operation between 30% and 50% have been reported after internal fixation for this type of fracture.1,5The risk of poor healing after internal fixation may be less for male patients, although the evidence for this is not conclusive.5,6 Newer implants for internal fixation have been introduced which may be associated with a reduction in the rate of revision.7-9 This randomised trial compares cemented hemiarthroplasty using the Exeter Trauma Stem (ETS, Stryker, Mahwah, New Jersey) with one such newer implant, the Targon Femoral Plate (FN) (B Braun, Tuttlingen, Germany), in elderly male patients.

Patients and Methods All male patients aged > 50 years admitted to Peterborough City Hospital with a displaced intracapsular fracture of the femoral neck were considered for inclusion; those aged < 50 years or with a life expectancy of > ten years based on patient assessment were excluded owing to a high likelihood of requiring revision arthroplasty if hemiarthroplasty was undertaken as a primary procedure. Very frail patients who were felt to be at too a high surgical risk from cemented hemiarthroplasty were also excluded and usually treated by internal fixation. In

addition patients who declined to participate, patients admitted when MJP was not available to supervise treatment, those in whom the delay between injury and presentation of more than two days was felt to be significant enough to influence fracture healing and those patients in whom the surgeon felt a comorbidity affected the choice of treatment (e.g., sepsis at the site of surgery) were also excluded. Assessment of the patients on admission included the American Society of Anaesthesiologists grade,10 a mobility scale adapted from a mobility score11 and a social dependency scale (Table I). Randomisation was by numbered sealed opaque envelope, prepared by an individual independent to the study. Once randomised to a group, all patients were analysed on an intention-to-treat basis. In order to standardise surgical technique, all operations were undertaken or directly supervised by MJP. A cemented Exeter trauma stem (ETS) inserted via an antero-lateral approach was used for those patients who were randomised to receive a hemiarthroplasty. Internal fixation was performed using the fracture table and image intensification, with closed reduction and fixation with a Targon FN.9 After surgery, all patients were encouraged to mobilise fully weight bearing, with no restriction on movements of the hip. The protocols for post-operative care were identical for both THE BONE & JOINT JOURNAL

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Table I. Assessment scales used Score

Pain

1

No pain at all in the hip

2

3

4 5

6

7

8

Mobility scale

Social dependence

Never uses any walking aid and no restriction in walking distance Never uses any walking aid but walking Occasional and slight pain. May occasionally take mild analgesia such as distance limited to less than one kilometer paracetamol Some pain when starting to walk, no Occasionally uses a walking aid when rest pain. Occasional analgesia taken out walking

None or minimal pain at rest, some pain with activities, frequent mild analgesia. Regular pain with activities which limits walking distance. Occasional or mild rest pain Frequent rest pain and pain at night. Pain on walking. Regular mild analgesia and occasional stronger analgesia taken Constant pain present around the hip. Regular mild analgesia and frequent strong analgesia

Constant and severe pain in the hip requiring regular strong analgesia such as opiates

9 10

Normally uses one walking stick or needs to hold onto furniture Normally used two sticks or crutches

Mobilises with a frame alone, without the need for assistance

Mobilises with a frame and the assistance of 1 person

Mobilises with a frame and the assistance of 2 people

Completely independent. Requires no assistance in basic or advanced ADL including shopping Minimal assistance. Requires occasional help up to twice a week from family, friends or others services, with some activities such as shopping or gardening Moderate assistance. Requires regular assistance more than twice a week but less than seven times a week with some ADL such as bathing, washing or heavy housework Regular assistance. Requires daily help daily to assist with ADL Dependent. Requires regular help more than once a day with many basic ADL such as preparing food and housework but remains living at home Severely dependent. Living in residential care. Full time care facility but independent of at least one ADL such as being able to dress or go to the toilet without help Fully dependent. Living in nursing home, skilled nursing home or long-term hospital facility with full time nursing cares. Patient requires assistance in most activities of daily living such as washing, dressing and getting to the toilet Patient in hospital requiring both nursing and medical care

Bed to chair (with or without assistance) or wheelchair bound Bedbound most or all of the day

ADL, activities of daily living

groups. All patients without contraindications received thromboprophylaxis with low molecular weight heparin for 28 days. The length of stay in hospital, including that spent on a rehabilitation ward, until discharge was recorded. The patients were initially reviewed eight weeks from admission, when all were assessed clinically and radiologically. A research nurse, blinded to the type of surgical procedure used, assessed pain using a modified Charnley pain score (Table I),12 a mobility scale and a social dependency score (Table I). Subsequent telephone assessments were made by the nurse at three, six, nine and 12 months from injury. In these, enquiries were made about whether the patient had undergone any further surgery and the assessments shown in Table I were once again recorded. The primary outcome for the study was recovery of mobility as measured by the mobility scale. A power calculation indicated that 400 patients would need to be recruited using this outcome measure, allowing for deaths and loss to follow-up. This number of patients was felt to be unrealistic for a single centre, so the study was undertaken as a pilot to assess the potential for a larger study. There was no external source of funding for this study. Internal funding was from the Peterborough Hospital Hip Fracture Fund. The study had ethical approval. Statistical analysis. Binary outcomes for the two groups were analysed using Fisher’s exact test and continuous outcomes with the unpaired two tailed t-test. (GraphPad InStat VOL. 97-B, No. 7, JULY 2015

version 3.00 for Windows 95, GraphPad Software, San Diego, California). A p-value of < 0.05 was considered statistically significant. Patients were recruited to the study between January 2012 and October 2013. Figure 1 gives the flow diagram for the patients included and excluded from the study with 139 potential patients admitted during this time. One patient in the arthroplasty group had surgery with a different surgeon, and one patient in the fixation group died before surgery. No patient was lost to follow-up.

Results There were no significant differences in the characteristics of the patients at admission in the two groups (Table II). The operative details, length of hospital stay and complications for the two groups are shown in Table III. There were no wound infections in either group. There were no surgical complications or re-operations in the hemiarthroplasty group. In the fixation group, seven patients developed nonunion and one developed symptomatic osteonecrosis. Five of these were treated with a cemented hemiarthroplasty, three with a total hip arthroplasty (THA). One plate detached from the femur but this did not require revision surgery. Total hospital stay included any additional time spent in hospital for the management of complications related to the fracture. There was no difference in mortality between the two groups (Fig. 2). Persistent pain, recovery of mobility and change of social dependency for the two groups are shown in Figures 3 to 5.

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139 male patients admitted with a displaced intracapsular hip fracture between January 2012 and October 2013

Excluded for not meeting inclusion criteria* (83) Lead trialist not available (49) Patient too young (16) Patient in alternative randomised trial (19) No consent (5) Conservative treatment (2) Patient unfit for arthroplasty (2) Pathological fracture (1) Infection at operation site (1) Limb in plaster (1) Patient refused (1) Randomised (56)

Allocated to hemiarthroplasty (26) Treated as per protocol (25) Operation by another surgeon (1)

Allocated to internal fixation (30) Treated as per protocol (29) Patient died before surgery (1)

Completed 1 year follow-up (19) Died during follow-up period (7) Lost to follow-up (0)

Completed 1 year follow-up (20) Died during follow-up period (10) Lost to follow-up (0) Fig. 1

Flow diagram for participants. *Some patients may be excluded for more than one reason.

1.00

3

Hemiarthroplasty Internal fixation

0.95

2.5

Pain score

0.90

Mortality

Hemiarthroplasty Internal fixation

0.85 0.80 0.75 0.70

p = 0.07

p = 0.006

2

p = 0.005 p = 0.2

1.5

p = 0.04

0.65 1

0.60 0.55 0.50

0.5 0

50

100

150

200

250

300

350

400

Days

2 mnths

3 mnths

6 mnths

9 mnths

1 yr

Time point

Fig. 2

Fig. 3

Graph showing Kaplan–Meier survival curve demonstrating mortality by group.

Graph showing pain scores by group with statistical significance at each time point.

Those patients treated by hemiarthroplasty had less persistent pain in the hip, whilst there was no statistically significant difference for the change in the mobility or social dependency scale for any of the time periods.

tendency to a shorter hospital stay. These advantages were short-lived and outweighed by the increased risk of reoperation. There was also more persistent pain in those treated by internal fixation. In contrast, the results for the 26 patients treated with hemiarthroplasty were excellent, with no complications related to the prosthesis. Their persistent pain in the hip was negligible and their recovery of function excellent. The study was, therefore, discontinued at this point.

Discussion Despite the small number of patients in this study a number of conclusions can be made. Those patients treated by internal fixation had a reduced length of surgery and a

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HEMIARTHROPLASTY VERSUS INTERNAL FIXATION FOR DISPLACED INTRACAPSULAR FRACTURES OF THE HIP IN ELDERLY MEN

Hemiarthroplasty Internal fixation

p = 0.4

Change in social dependency

Change in mobility scale

3.5

3

p = 1.0

p = 0.7 p = 1.0

p = 0.9

2.5

2 2 mnths

3 mnths

6 mnths

9 mnths

1 yr

2.5

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Hemiarthroplasty Internal fixation

2

p = 0.5 1.5

p = 0.1 p = 0.8

p = 0.4

p = 0.9

1 0.5

0 2 mnths

3 mnths

Time point

6 mnths

9 mnths

1 yr

Time point

Fig. 4

Fig. 5

Graph showing change in mobility scale with statistical significance at each time point.

Graph showing change in social dependency score with statistical significance at each time point.

Table II. Characteristics of the two groups at admission

Patient numbers Mean age (yrs) (range) From own home (n, %) ASA grade 1 or 2 (n, %) Mean mobility scale Mean social dependency score

Hemiarthroplasty

Internal fixation

26 81.2 (65 to 91) 22 (84.6) 7 (26.9) 3.2 3.6

30 81.5 (62 to 94) 24 (80.0) 6 (20.0) 3.5 3.5

ASA, American Society of Anaesthesiologists

Table III. Operative details and post-operative complications by implant

Mean operating time (mins) (SD) Number of patients transfused (n, %) Pneumonia (n, %) Atrial fibrillation (n, %) Myocardial infarction Acute renal injury (n, %) Urinary retention (n, %) Deep vein thrombosis (n, %) Pressure sores (n, %) Re-operations (n, %) Mean hospital stay (days) (SD) Mean total hospital stay (days) (SD) Mortality 30 days (n, %) Mortality one year (n, %) SD,

Hemiarthroplasty

Internal fixation

p-value

53.3 (19.2) 2 (7.7) 1 (3.8) 0 0 1 (3.8) 5 (19.2) 1 (3.8) 1 (3.8) 0 (0.0) 24.2 (22.5) 25.1 (23.8) 1 (3.8) 7 (26.9)

36.7 (16.9) 0 0 1 (3.3) 1 0 2 (6.7) 0 0 8 (26.7) 15.9 (12.1) 19.4 (18.2) 3 (10.0) 10 (33.3)

0.001 0.2 0.5 1.0 1.0 0.5 0.2 0.5 0.5 0.005 0.09 0.3 0.6 0.8

standard deviation

The strengths of this study were the randomisation of patients, the standardised surgical technique, the complete follow-up of all patients and the blinded assessment of outcome. The use of a modern cemented hemiarthroplasty stem is recommended by the current United Kingdom Guidance on hip fractures.2 The ETS is based on the femoral component of the Exeter total hip system, which has an Orthopaedic Data Evaluation Panel (ODEP) rating of 10A. The monobloc ETS does not itself, however, have an ODEP rating and its use has been largely confined to the United Kingdom since its introduction in 2006. Satisfactory short-term VOL. 97-B, No. 7, JULY 2015

results have been reported,13,14 although concern has been expressed over the surface finish of the implant which differs from that used for THA.15 The Targon FN is also relatively new. It was introduced in 2006 and to date the reports of the outcome have shown the risk of fracture healing complication is equivalent or even less than that for older implants.7-9,16,17 The controversy between internal fixation and arthroplasty for the treatment of displaced intracapsular fractures is largely resolved. The consensus is that most patients with a displaced intracapsular fracture are best treated by

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arthroplasty.1-3,18 The reason for this is the high risk of nonunion and osteonecrosis after internal fixation, necessitating revision surgery. The incidence of thesecomplications is reported to be 49%.1 The rate of nonunion in the current study was < 24%. In conclusion, this randomised pilot study found clear tendency to improved outcomes in elderly men treated with cemented hemiarthroplasty using an ETS compared with those treated using the Targon FN fixation device. This is in keeping with existing guidance, which is to avoid internal fixation in the management of displaced intracapsular fractures of the femoral neck in the elderly. Author contribution: M. J. Parker: Study initiation, Patient recruitment, Data collection, Data analysis, Performed surgeries, Writing the paper. The author has received expenses and honoraria from a number of commercial companies and organisations for giving lectures on different aspects of hip fracture treatment. In addition he has received royalties from B Braun Ltd related to the design and development of the Targon FN implant used for the internal fixation of intracapsular hip fractures.

4. Parker MJ. The management of intracapsular fractures of the proximal femur. J Bone Joint Surg [Br] 2001;83-B:618–619. 5. Parker MJ, Raghavan R, Gurusamy K. Incidence of fracture-healing complications after femoral neck fractures. Clin Orthop Relat Res 2007;458:175–179. 6. Brown JT, Abrami G. Transcervical femoral fracture: a review of 195 patients treated by sliding nail-plate fixation. J Bone Joint Surg [Br] 1964;46-B:648–663. 7. Eschler A, Brandt S, Gierer P, Mittlemeier T, Gradl G. Angular stable multiple screw fixation (Targon FN) versus standard SHS for the fixation of femoral neck fractures. Injury 2013;455:576–580. 8. Griffin XL, Parsons N, Achten J, Costa ML. The Targon femoral neck hip screws versus cannulated screws for internal fixation of intracapsular fractures of the hip. Bone Joint J 2014;96-B:652–657. 9. Parker M, Cawley S, Palial V. Internal fixation of intracapsular fractures of the hip using a dynamic locking plate: two-year follow-up of 320 patients. Bone Joint J 2013;95-B:1402–1405. 10. No authors listed. American Society of Anaesthesiologists new classification of physical status. Anaesthesiology 1963;24:111. 11. Parker MJ, Palmer CR. A new mobility score for predicting mortality after hip fracture. J Bone Joint Surg [Br] 1993;75-B:797–798. 12. Charnley J. The long-term results of low-friction arthroplasty of the hip performed as a primary intervention. J Bone Joint Surg [Br] 1972;54-B:61–76. 13. Cash D, Bayer J, Logan K, Wimhurst J. The Exeter Trauma Stem. Early results of a new cemented hemiarthroplasty for femoral neck fracture. BJMP 2010;3:303.

The author has received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.

14. Parker MJ. Cemented Thompson hemiarthroplasty versus cemented Exeter Trauma Stem (ETS) hemiarthroplasty for intracapsular hip fractures: a randomised trial of 200 patients. Injury 2012;43:807–810.

This article was primary edited by P. Page and first proof edited by J. Scott.

15. Petheram TG, Bone M, Joyce TJ, et al. Surface finish of the Exeter Trauma Stem: a cause for concern? Bone Joint J 2013;95-B:173–176.

References

16. Biber R, Brem M, Bail HJ. Targon Femoral Neck for femoral-neck fracture fixation: lessons learnt from a series of one hundred and thirty five consecutive cases. Int Orthop 2014;38:595–599.

1. Lu-Yao GL, Keller RB, Littenberg B, Wennberg JE. Outcomes after displaced fractures of the femoral neck. A meta-analysis of one hundred and six published reports. J Bone Joint Surg [Am] 1994;76-A:15–25. 2. No authors listed. The Management of Hip Fracture in Adults. National Clinical Guideline Centre (NICE). www.ncgc.ac.uk (date last accessed 17 February 2015). 3. Parker MJ, Gurusamy K. Internal fixation versus arthroplasty for intracapsular proximal femoral fractures in adults. Cochrane Database Syst Rev 2006;18:CD001708.

17. Körver RJP, Wieland AWJ, Kaarsemaker S, Nieuwenhuis JJ, Janzing HM. Clinical experience, primary results and pitfalls in the treatment of intracapsular hip fractures with the Targon® FN locking plate. Injury 2013;44:1926–1929. 18. Gao H, Liu Z, Xing D, Gong M. Which is the best alternative for displaced femoral neck fractures in the elderly? A meta-analysis. Clin Orthop Relat Res 2012;470:1782– 1791.

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