The Journal of Bone & Joint Surgery

The Journal of Bone & Joint Surgery, Volume 92, Issue 4

Scientific Articles | April 01, 2010

A Comparison of the Long Gamma Nail with the Sliding Hip Screw for the Treatment of AO/OTA 31-A2 Fractures of the Proximal Part of the Femur: A Prospective Randomized Trial

Tristan M. Barton, MBChB, MSc¹; Robert Gleeson, FRCS(Orth)¹; Claire Topliss, FRCS(Orth)¹; Rosemary Greenwood, MSc¹; William J. Harries, FRCS(Orth)¹; Timothy J.S. Chesser, FRCS(Orth)¹

¹ Department of Trauma and Orthopaedics, Frenchay Hospital, Frenchay Park Road, Frenchay, Bristol BS6 1LE, United Kingdom. E-mail address for T.M. Barton: tristan_barton@hotmail.com

View Disclosures and Other Information

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

A commentary by Jeffrey O. Anglen, MD, is available at www.jbjs.org/commentary and as supplemental material to the online version of this article.

Investigation performed at the Department of Trauma and Orthopaedics, Frenchay Hospital, Bristol, United Kingdom

J Bone Joint Surg Am, 2010 Apr 01;92(4):792-798. doi: 10.2106/JBJS.I.00508

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Abstract

Background:

Controversy exists with regard to whether to treat AO/OTA 31-A2 fractures of the proximal part of the femur with an intramedullary device or an extramedullary device. A prospective, randomized, controlled trial was performed to compare the outcome of treatment of these unstable fractures of the proximal part of the femur with either a sliding hip screw or a long gamma nail.

Methods:

Two hundred and ten patients presenting with an AO/OTA 31-A2 fracture of the proximal part of the femur were randomized, at the time of admission, to fixation with use of either a long gamma nail or a sliding hip screw. The primary outcome measure was reoperation within the first postoperative year. Secondary measures included mortality, length of hospital stay, transfusion rate, change in mobility and residence, and quality of life as measured with the EuroQol 5D outcome score.

Results:

There was no significant difference between the reoperation rates for the two groups. In total, five patients (three from the long-gamma-nail group and two from the sliding-hip-screw group) underwent revision surgery because of cut-out. Tip-apex distance was found to correlate with the implant cut-out rate. There was no significant difference between the two groups in terms of the EuroQol 5D outcome scores, the mortality rates after correction for the mini-mental score, or any of the secondary outcome measures.

Conclusions:

When compared with the long gamma nail, the sliding hip screw should remain the gold standard for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur because it is associated with similar outcomes with less expense.

Level of Evidence:

Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

Figures in this Article

Introduction

Introduction | Materials and Methods | Results | Discussion | References

Intertrochanteric fractures of the proximal part of the femur have been treated successfully with use of the sliding hip screw over the last thirty years. It is accepted in the literature that this is the implant of choice for the treatment of stable (AO/OTA [Arbeitsgemeinschaft für Osteosynthesefragen/Orthopaedic Trauma Association] 31-A1) fractures¹, but controversy still exists with regard to the treatment of the more unstable (AO/OTA 31-A2 and A3) fractures (Fig. 1)². There is an increasing body of evidence to indicate that reverse oblique fractures of the proximal part of the femur (A3) are best treated with use of an intramedullary device^3,4; however, the optimum treatment of comminuted fractures involving the lesser trochanter (A2) is less clear. Parker and Handoll, in a Cochrane review article that was published in 2008, concluded from a meta-analysis of the literature that the sliding hip screw was preferable to intramedullary devices for the treatment of extracapsular fractures because of lower complication rates, but additional studies were needed for the investigation of the unstable fracture subgroup².

The aim of the present study was to test the hypothesis that there is no difference between the sliding hip screw (Omega 2; Stryker, Newbury, United Kingdom) and the long gamma nail (Dyax; Stryker) in terms of the primary outcome measure (defined as reoperation within the first postoperative year) when used for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur. The indications for revision surgery included screw cut-out, implant failure, late fracture, and deep infection. Secondary outcomes included mortality, a requirement for transfusion, length of hospital stay, mobility, change in residence, and EuroQol 5D outcome score.

Fig. 1

AO/OTA classification of pertrochanteric hip fractures. (Reprinted, with modification, from: Müller AO Classification of Fractures—Long Bones [http://www.aofoundation.org/AOFileServer/PortalFiles?FilePath=/Extranet/en/_att/wor/act/fracture_classif/mueller_ao_class.pdf]. Reprinted with permission from the AO Foundation.)

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Materials and Methods

Introduction | Materials and Methods | Results | Discussion | References

The present study received local ethical board permission and was registered with the International Standard Randomised Control Trial Number Register (ISRCTN79362886). All patients over the age of eighteen years who had been admitted to the treating hospital with an AO/OTA 31-A2 fracture of the proximal part of the femur were considered for inclusion in the study. The exclusion criteria included pathological fractures, previous proximal femoral fractures, reverse oblique fractures (AO/OTA 31-A3), and a decision by the surgeon responsible for the patient's care not to include the patient in the study. In this last group, which comprised four patients, the decision was not made on the basis of the pathoanatomy of the fracture. At the time of admission, appropriate patients were randomized to fracture fixation with use of either a sliding hip screw or a long gamma nail. Randomization was carried out with use of sealed envelopes generated by a medical statistician. Once a patient was considered to be appropriate for inclusion, consent was obtained. An envelope was then selected and opened at a daily trauma meeting so that appropriate operative planning could be performed. A total of 300 envelopes were generated, and 210 patients were recruited. This discrepancy resulted in unequal numbers in the two recruitment arms. All able patients gave informed consent to enter the trial. Patients who were unable to provide consent were entered into the trial after discussion with the next of kin. There was no blinding of the selected treatment to either the patients or healthcare providers involved in the patients’ care.

Two hundred and ten consecutive patients who met the inclusion criteria were enrolled into the trial, of whom 100 were randomized to treatment with a gamma nail and 110 were randomized to treatment with a sliding hip screw. Two patients in the long-gamma-nail group died before surgery. Figure 2 shows the flow of participants through each stage of the trial. An initial power calculation produced a sample requirement of 220 patients (as described in the Statistical Methods section), but, because of external factors, the trial was concluded after the recruitment of 210 patients.

Fig. 2

Diagram showing the flow of participants through each stage of the trial.

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Patients were admitted to the trauma ward and were managed with aspirin and thromboembolism-deterrent stockings for thromboprophylaxis (unless contraindicated). All patients were managed operatively at the earliest opportunity, with a consultant orthopaedic surgeon (T.M.B., R.G., C.T., W.J.H., T.J.S.C.) either performing the operation or in attendance. All surgeons had experience with the two implants, and a total of thirty-two surgeons (including five of the authors [T.M.B., R.G., C.T., W.J.H., T.J.S.C]) performed the operations. Fracture reduction was performed on a traction table before fixation. In the sliding-hip-screw group, a four-hole, 135° plate was inserted. In the long-gamma-nail group, the femur was reamed to 1 mm greater than the diameter of the nail, and a 130° nail of the appropriate length was inserted; all nails were locked distally with two screws. In all cases, efforts were made to achieve optimum positioning of the tip of the screw in the subchondral bone of the femoral head with a combined tip-apex distance measuring <25 mm on anteroposterior and lateral radiographs.

Patients were mobilized bearing full weight under the supervision of a physiotherapist. Following discharge, patients were evaluated both clinically and radiographically at three, six, and twelve months. Reoperation and mortality data were available for all patients who were included in the trial. Because of ill health, a substantial number of patients (21%) were unable to return for follow-up. In these instances, follow-up was completed at one year by means of a telephone consultation, and radiographic review was not possible.

Radiographic evaluation following fracture fixation included the measurement of the tip-apex distance, which is defined as the combined distance from the tip of the screw to the apex of the femoral head on the anteroposterior and lateral radiographs. A total distance measuring >25 mm has been shown to be associated with an increased rate of screw cut-out from the femoral head⁵.

Functional outcome was assessed with use of the EuroQol 5D questionnaire. The EuroQol 5D is a validated patient-based measure of health outcome consisting of five lifestyle questions, each scored from 1 to 3 points⁶. These scores are then entered into a formula to produce an outcome score for each patient between -0.200 (minimum score) and 1.000 (maximum score). Patients who died within the study period received a score of 0. A second component of EuroQol 5D utilizes a visual analog score (EQ VAS). Because of the large number of patients with reduced mental capacity who were included in the study, this scale was not used. EuroQol 5D outcome scores were available for 88% of the patients in the study group in the first postoperative year. The reason for the incomplete data was either inadequate completion of the EuroQol 5D questionnaire or an inability to identify a surrogate who was able to complete the questionnaire on behalf of a patient with a reduced mental capacity. Mobility and residency were scored at the time of admission and at one year on a scale of 1 to 5 (Table I). These data were available for 88% of the patients in the trial for the reasons noted above.

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TABLE I Scoring of Mobility and Residency

Score	Mobility	Residency
1	Unaided	Own home
2	One cane or crutch	Sheltered housing
3	Two canes or crutches	Residential home
4	Walker	Nursing home
5	Wheelchair	Hospital

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TABLE I Scoring of Mobility and Residency

Score	Mobility	Residency
1	Unaided	Own home
2	One cane or crutch	Sheltered housing
3	Two canes or crutches	Residential home
4	Walker	Nursing home
5	Wheelchair	Hospital

Statistical Methods

The power calculation was based on the primary outcome measure of implant failure or cut-out, with anticipated failure rates of 5% for the long gamma nail and 18% for the sliding hip screw. These values were calculated from published departmental data and previous local audit⁷. A two-tailed continuity-corrected chi-squared test with 80% power and a 5% level of significance produced a required sample size of 220 patients (110 per group). Analysis of reoperation rates, mortality, tip-apex distance, and transfusion rates was performed with use of regression methods. The length of hospital stay was analyzed by means of survival analysis with use of a log-rank test. EuroQol 5D scores were compared with use of linear regression on the basis of the area under the curve over a period of twelve months both before and after controlling for the mini-mental score. Because of incomplete EuroQol 5D scores for a number of patients, multiple imputation methods with eight sets of data were used to produce the mean difference between the long gamma nail and the sliding hip screw, together with confidence intervals.

Source of Funding

There was no external funding source for this project.

Results

Introduction | Materials and Methods | Results | Discussion | References

The demographic and preoperative variables were comparable between the two groups, with the exception of the mini-mental score (Table II). The long-gamma-nail group included a significantly higher proportion of patients with a reduced mini-mental score (p = 0.04). Mortality, the EuroQol 5D score, and the duration of hospital stay were found to be strongly associated with a reduced mental capacity. These outcomes were therefore corrected for the mini-mental score when comparative analyses were performed between the two groups.

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TABLE II Demographic Characteristics

	Total	Long Gamma Nail	Sliding Hip Screw	P Value
No. of patients	210	100	110
Sex (no. of patients)				>0.05
Female	166	81	85
Male	44	19	25
Age*(yr)	83.2 (42 to 99)	83.1 (42 to 99)	83.3 (56 to 97)	>0.05
Side of fracture (no. of patients)				>0.05
Left	112 (53%)	50 (50%)	62 (56%)
Right	98 (47%)	50 (50%)	48 (44%)
Mini-mental score (no. of patients)				0.04
10 points	112 (53%)	45 (45%)	67 (61%)
<10 points	98 (47%)	55 (55%)	43 (39%)
ASA score†(no. of patients)				>0.05
1	2 (1%)	0 (0%)	2 (2%)
2	93 (44%)	47 (47%)	46 (42%)
3	108 (51%)	49 (49%)	59 (54%)
4	7 (3%)	4 (4%)	3 (3%)

*The values are given as the mean, with the range in parentheses.
†ASA = American Society of Anesthesiologists.

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TABLE II Demographic Characteristics

	Total	Long Gamma Nail	Sliding Hip Screw	P Value
No. of patients	210	100	110
Sex (no. of patients)				>0.05
Female	166	81	85
Male	44	19	25
Age*(yr)	83.2 (42 to 99)	83.1 (42 to 99)	83.3 (56 to 97)	>0.05
Side of fracture (no. of patients)				>0.05
Left	112 (53%)	50 (50%)	62 (56%)
Right	98 (47%)	50 (50%)	48 (44%)
Mini-mental score (no. of patients)				0.04
10 points	112 (53%)	45 (45%)	67 (61%)
<10 points	98 (47%)	55 (55%)	43 (39%)
ASA score†(no. of patients)				>0.05
1	2 (1%)	0 (0%)	2 (2%)
2	93 (44%)	47 (47%)	46 (42%)
3	108 (51%)	49 (49%)	59 (54%)
4	7 (3%)	4 (4%)	3 (3%)

*The values are given as the mean, with the range in parentheses.
†ASA = American Society of Anesthesiologists.

The results for both groups are displayed in Table III. Two patients (2%) in the sliding-hip-screw group and three patients (3%) in the long-gamma-nail group required an additional operation. All five reoperations were performed because of screw cut-out, and there were no cases of implant failure or deep infection. There was no significant difference between the two groups with regard to the rate of the reoperation (p = 0.67).

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TABLE III Results

	Long Gamma Nail	Sliding Hip Screw	P Value	Method	Estimate	95% Confidence Interval
Reoperation rate (no. of patients)	3 (3%)	2 (2%)	0.67	Logistic regression (odds ratio)	1.71	0.28, 10.42
Mortality (no. of patients)
Thirty days*	21 (21%)	11 (10%)	0.13	Survival analysis (hazard ratio)	1.69	0.81, 3.45
One year*	32 (32%)	24 (22%)	0.26	Survival analysis (hazard ratio)	1.36	0.80, 2.31
Tip-apex distance >25 mm (no. of patients)	8 (8%)	10 (9%)	0.51	T test (mean difference)	0.83	1.68, 3.34
Length of hospital stay*†(days)	32 (1 to 164)	31 (1 to 154)	0.17	Survival analysis (hazard ratio)	0.82	0.61, 1.13
Transfusion (no. of patients)	50 (51%)	46 (42%)	0.14	Logistic regression (odds ratio)	1.5	0.87, 2.61
Change in mobility score‡(points)	1.83	1.49	0.26	T test (mean difference)	0.34	—0.25, 0.93
Change in residency score‡(points)	1.16	1.23	0.79	T test (mean difference)	—0.07	—0.60, 0.45

*Corrected for the mini-mental score.
†The values are given as the mean, with the range in parentheses.
‡The values are given as the mean.

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TABLE III Results

	Long Gamma Nail	Sliding Hip Screw	P Value	Method	Estimate	95% Confidence Interval
Reoperation rate (no. of patients)	3 (3%)	2 (2%)	0.67	Logistic regression (odds ratio)	1.71	0.28, 10.42
Mortality (no. of patients)
Thirty days*	21 (21%)	11 (10%)	0.13	Survival analysis (hazard ratio)	1.69	0.81, 3.45
One year*	32 (32%)	24 (22%)	0.26	Survival analysis (hazard ratio)	1.36	0.80, 2.31
Tip-apex distance >25 mm (no. of patients)	8 (8%)	10 (9%)	0.51	T test (mean difference)	0.83	1.68, 3.34
Length of hospital stay*†(days)	32 (1 to 164)	31 (1 to 154)	0.17	Survival analysis (hazard ratio)	0.82	0.61, 1.13
Transfusion (no. of patients)	50 (51%)	46 (42%)	0.14	Logistic regression (odds ratio)	1.5	0.87, 2.61
Change in mobility score‡(points)	1.83	1.49	0.26	T test (mean difference)	0.34	—0.25, 0.93
Change in residency score‡(points)	1.16	1.23	0.79	T test (mean difference)	—0.07	—0.60, 0.45

*Corrected for the mini-mental score.
†The values are given as the mean, with the range in parentheses.
‡The values are given as the mean.

The tip-apex distance measured =25 mm in 92% of the patients in the study group. There was no difference between the two groups in terms of the mean tip-apex distance (p = 0.51). Three of the five patients requiring reoperation had a tip-apex distance of >25 mm; this proportion was significantly higher than that among patients not requiring revision surgery (7%) (p = 0.01).

There was a significant difference between the two groups in terms of the one-year mortality rate. The mortality rate at one year was 32% in the long-gamma-nail group, compared with 22% in the sliding-hip-screw group (p = 0.045; odds ratio = 1.71). However, there was no significant difference between the two groups in terms of the mortality rates after controlling for the mini-mental score (p = 0.26). There was no significant difference between the two groups with regard to length of hospital stay when corrected for the mini-mental score. There was also no difference between the groups with regard to the postoperative transfusion rate, although there was a trend for patients in the long-gamma-nail group to require more frequent transfusions (odds ratio = 1.5).

EuroQol 5D scores were found to be strongly associated with the mini-mental score. The mean quality-adjusted life-year (QUALY) was 0.37 for the long-gamma-nail group and 0.46 for the sliding-hip-screw group. There was no significant difference between the two groups with regard to the QUALY score when adjusted for the mini-mental score (mean difference, 0.04 [95% confidence interval, —0.026 to 0.111]). Deterioration in patient mobility and independence following fracture fixation was similar between the two groups. Each patient dropped on average one level of mobility and one level of home independence following hip fracture fixation.

Discussion

Introduction | Materials and Methods | Results | Discussion | References

Over the last fifteen years, there has been a great deal of controversy over the optimum treatment of intertrochanteric fractures of the proximal part of the femur. The two options of extramedullary and intramedullary fixation have been studied and debated at length, with arguments over biomechanical strength, implant failure rates, periprosthetic fracture rates, ease of operation, and functional outcome⁸. Level-1 studies have suggested that the sliding hip screw is the treatment of choice for stable intertrochanteric fractures, but debate continues with regard to the optimum treatment for unstable fractures of the proximal part of the femur involving the lesser trochanter^2,9.

The recent literature has demonstrated a change of practice in the treatment of intertrochanteric fractures, with a dramatic increase in the number of intramedullary devices being used. This increase has not been backed up by scientific evidence but has been driven by other factors, including marketing by industry, surgeon preference, and reimbursement¹⁰. The trend toward more frequent intramedullary fixation of intertrochanteric fractures in Medicare patients across the United States has been reported recently, but it cannot be explained by patient-related factors¹¹. In a study of candidates taking the Part II American Board of Orthopaedic Surgery examination, the intramedullary fixation rate for intertrochanteric fractures increased from 3% to 67% between 1999 and 2006¹². This increase occurred without a significant improvement in terms of functional outcome or patient satisfaction in comparison with the sliding hip screw. However, the increase in the use of intramedullary fixation was associated with a higher rate of procedure-related complications. In addition, the choice of implant has clear cost implications, with the current list price for the sliding hip screw being approximately £1000 ($1500) less than that of the long gamma nail.

It has been difficult to extract up-to-date evidence from the literature because of the evolution in the design of the intramedullary devices¹³. The relevance of early studies is limited as those studies included the original nail designs, which were subsequently modified. More recently, companies have produced variations of designs, with good results in cohort series^14,15. In a Cochrane review from 2008, thirty-two trials involving 5088 patients were analyzed². That study demonstrated a lower complication rate for the sliding hip screw than for the intramedullary nail, the latter of which was associated with increased rates of periprosthetic fracture and reoperation.

The introduction of the newer long intramedullary nails has reduced the rate of both intraoperative fracture and subsequent femoral fracture in comparison with the rates that were seen in association with the shorter nails¹⁶. The present study confirms this finding, with no cases of intraoperative or postoperative fractures being observed among 100 patients who were managed with the long gamma nail. There is also a well-documented learning curve associated with intramedullary fracture fixation, after which the intraoperative complication rate decreases significantly^7,17.

Improvements in implant design, combined with the theoretical biomechanical advantages of intramedullary fixation, have been proposed to result in a lower reoperation rate following fixation in comparison with the rate associated with the sliding hip screw. However, our findings reinforce the conclusions of a meta-analysis, published in 2006, which identified no difference in the reoperation rate after the treatment of unstable fractures with an intramedullary device or a sliding hip screw¹³. These findings may be related to the low functional demands of the elderly patients who sustain this injury. The demographic characteristics of our study group were comparable with those reported in the European and North American literature^11,12. Despite the presence of an osteoporotic proximal part of the femur, plate fixation with four bicortical screws appears to provide adequate fixation.

Our results suggest that the operation was performed technically correctly, with only 8% of the patients having a tip-apex distance of >25 mm. The importance of the tip-apex distance is emphasized by the fact that three of the five patients who required revision surgery had a tip-apex distance in excess of the recommended upper limit of 25 mm. The importance of the tip-apex distance is likely to be greater in patients with unstable intertrochanteric fractures. In patients with stable fractures with an intact posteromedial buttress, the load is shared between the implant and the calcar femorale; however, in patients with unstable fractures, the entire load is transmitted through the implant because of the loss of this posteromedial support.

Even though only one type of nail design was studied, the results for this group were comparable with or better than those reported in other series involving other nail designs². A multicenter study¹⁸ evaluating the results of the Proximal Femoral Nail (PFNA; Synthes, Hertfordshire, United Kingdom) for the treatment of 31-A1 and 31-A2 fractures in 315 patients demonstrated that forty-six patients (15%) had implant complications, with an overall reoperation rate of 9%. The authors of that study concluded that the proximal femoral nail with a helical blade should be the implant of choice for the treatment of these fractures. That study contained no control arm, and as a result one is not able to draw conclusions with regard to the optimum treatment of this fracture pattern. In a study evaluating the VeroNail (Orthofix, Verona, Italy) with locked converging screws, patients with unstable proximal femoral fractures had the same function as those managed with a sliding hip screw¹⁹.

The strengths of the present study include the randomization of >98% of the patients who were suitable for inclusion and the fact that the primary outcome was available in all cases. An additional strength was the inclusion of patients with a reduced mental capacity, with approximately half of the patients in the present study having a reduced mental capacity. As a consequence of this high proportion of patients with a reduced mental capacity and the general poor health of the study population, the rate of attendance for clinical review was reduced. Despite obtaining a telephone interview with many of these patients or their caregivers, there is a possibility that we did not identify patients with minimum symptoms who would have had evidence of implant failure or cut-out if radiographs had been made. Another weakness of the present study is that recruitment did not quite reach the initial power calculation as has been discussed in the methodology. Additional weaknesses were that the patients and healthcare providers were not blinded to the treatment method and that there was a lack of detailed data on the length of operating time and on intraoperative blood loss.

In conclusion, our study identified no difference in the reoperation rate following the fixation of AO/OTA 31-A2 fractures of the proximal part of the femur with a long gamma nail or a sliding hip screw. Furthermore, no difference was identified between the two groups with regard to quality of life as measured with EuroQol 5D outcome scores at one year. We conclude that the sliding hip screw should remain the gold standard for the treatment of such fractures.

References

Introduction | Materials and Methods | Results | Discussion | References

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Parker MJ; Handoll HH. Gamma and other cephalocondylic intramedullary nails versus extramedullary implants for extracapsular hip fractures in adults. Cochrane Database Syst Rev. 2008;3: CD000093.

Stern R. Are there advances in the treatment of extracapsular hip fractures in the elderly?Injury. 2007;38 Suppl. 3:S77-87.[PubMed][CrossRef]

Kregor PJ; Obremskey WT; Kreder HJ; Swiontkowski MF; Evidence-Based Orthopaedic Trauma Working Group. Unstable pertrochanteric femoral fractures. J Orthop Trauma. 2005;19:63-6.[PubMed][CrossRef]

Baumgaetner MR; Curtin SL; Lindskog DM; Keggi JM. The value of the tip-apex distance in predicting failure of fixation of peritrochanteric fractures of the hip. J Bone Joint Surg Am. 1995;77:1058-64.[PubMed]

Tidermark J; Bergström G; Svensson O; Törnkvist H; Ponzer S. Responsiveness of the EuroQol (EQ 5-D) and the SF-36 in elderly patients with displaced femoral neck fractures. Qual Life Res. 2003;12:1069-79.[PubMed][CrossRef]

Sehat K; Baker RP; Pattison G; Price R; Harries WJ; Chesser TJ. The use of the long gamma nail in proximal femoral fractures. Injury. 2005;36:1350-4.[PubMed][CrossRef]

Aros B; Tosteson AN; Gottlieb DJ; Koval KJ. Is a sliding hip screw or im nail the preferred implant for intertrochanteric fracture fixation?Clin Orthop Relat Res. 2008;466:2827-32.[PubMed][CrossRef]

Schipper IB; Marti RK; van der Werken C. Unstable trochanteric femoral fractures: extramedullary or intramedullary fixation. Review of literature. Injury. 2004;35:142-51.[PubMed][CrossRef]

Bozic KJ; Jacobs JJ. Technology assessment and adoption in orthopaedics: lessons learned. J Bone Joint Surg Am. 2008;90:689-90.[PubMed][CrossRef]

Forte ML; Virnig BA; Kane RL; Durham S; Bhandari M; Feldman R; Swiontkowski MF. Geographic variation in device use for intertrochanteric hip fractures. J Bone Joint Surg Am. 2008;90:691-9.[PubMed][CrossRef]

Anglen JO; Weinstein JN; American Board of Orthopaedic Surgery Research Committee. Nail or plate fixation of intertrochanteric hip fractures: changing pattern of practice. A review of the American Board of Orthopaedic Surgery Database. J Bone Joint Surg Am. 2008;90:700-7.[PubMed][CrossRef]

Jones HW; Johnston P; Parker M. Are short femoral nails superior to the sliding hip screw? A meta-analysis of 24 studies involving 3,279 fractures. Int Orthop. 2006;30:69-78.[PubMed][CrossRef]

Herrera A; Domingo LJ; Calvo A; Martinez A; Cuenca J. A comparative study of trochanteric fractures treated with the Gamma nail or the proximal femoral nail. Int Orthop. 2002;26:365-9.[PubMed][CrossRef]

Papasimos S; Koutsojannis CM; Panagopoulos A; Megas P; Lambiris E. A randomised comparison of the AMBI, TGN and PFN for treatment of unstable trochanteric fractures. Arch Orthop Trauma Surg. 2005;125:462-8.[PubMed][CrossRef]

Bjørgul K; Reikerås O. Outcome after treatment of complications of Gamma nailing: a prospective study of 554 trochanteric fractures. Acta Orthop. 2007;78:231-5.[PubMed][CrossRef]

Goldhagen PR; O'Connor DR; Schwarze D; Schwartz E. A prospective comparative study of the compression hip screw and the gamma nail. J Orthop Trauma. 1994;8:367-72.[PubMed][CrossRef]

Simmermacher RK; Ljungqvist J; Bail H; Hockertz T; Vochteloo AJ; Ochs U; Werken CV; AO - PFNA studygroup. The new proximal femoral nail antirotation (PFNA) in daily practice: results of a multicentre clinical study. Injury. 2008;39:932-9.[PubMed][CrossRef]

Lavini F; Renzi-Brivio L; Aulisa R; Cherubino F; Di Seglio PL; Galante N; Leonardi W; Manca M. The treatment of stable and unstable proximal femoral fractures with a new trochanteric nail: results of a multicentre study with the Veronail. Strategies Trauma Limb Reconstr. 2008;3:15-22.[PubMed] [CrossRef]

Topics

fracture ; bone nails ; bone screws ; femur ; hip joint ; nails ; repeat surgery

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Husam AL-Rumaih, MD

Posted on June 07, 2011

Re: Mr. Barton and colleagues respond to Dr. Al-Rumaih

Orthopedic Surgeon, Clinical Investigator, King Abdullah International Medical Research Center

I thank the author for his further explanation. The power of the study was not my argument (though it is an issue in this trial as the author pointed out). I'm arguing the way the hypothesis was formulated and tested. He stated clearly in his article 'The aim of the present study was to test the hypothesis that there is no difference between the sliding hip screw (Omega 2; Stryker, Newbury, United Kingdom) and the long Gamma nail (Dyax; Stryker)'. If that is your hypothesis. You directly confirmed the alternative hypothesis instead of rejecting the Null hypothesis . If your hypothesis was 'Gamma nail is superior to DHS' as I understood from your response. Then you failed to reject the Null hypothesis and your conclusion should be Gamma nail is not Superior (not better) as you pointed out in your response. It could be either the same or worse. Negative trials are as valuable as positive ones and the data is still valuable data. I think that the hypothesis (null and alternative) should be mentioned clearly in any trial since that is the cornerstone on which you build your testing. Furthermore we should always adhere to the CONSORT statement in reporting our clinical trials in orthopedics.

Tristan M. Barton, MBChB, MSc

Posted on May 20, 2011

Mr. Barton and colleagues respond to Dr. Al-Rumaih

North Bristol NHS Trust, United Kingdom

We thank Mr. Al-Rumaih for his interest in our article. We do not agree with his statistical summary and refute that no conclusions can be drawn. All published articles should be concise hence some of the additional data and explanations, which he mentions, were not included (some some being removed in the editorial process). The study was adequately powered from previous data for a primary outcome seeking a difference in re-operation rate. As this event was unexpectedly low then secondary outcomes were examined. As is common in clinical research the study was not powered to find differences in the secondary outcomes. The conclusions of the study were that the sliding hip screw remains the gold standard is supported by the data - we are not saying the long gamma nail is not equivalent or worse, just no better.

Husam A. Al-Rumaih

Posted on May 20, 2011

Hypothesis and Trial Design

Orthopedic Surgeon, Clinical Investigator, King Abdullah International Medical Research Center, Riyadh, Saudi Arabia

To the Editor:

I went through the design of the trial by Barton et al. (2010;92:792-8). I have some concerns regarding the design and the authors' hypothesis. The authors mentioned “The aim of the present study was to test the hypothesis that there is no difference between the sliding hip screw’. This hypothesis implies using a clinical equivalence trial design (1). This requires predefining the acceptable difference between the two treatments (δ) which I failed to locate in the article (2). Regarding hypothesis testing, It is the null hypothesis (there is a difference) that is rejected in favor of the alternative hypothesis (there is no difference). I cannot understand confirming the alternative hypothesis without rejecting the null. The authors went directly and confirmed the alternative hypothesis without rejecting the null hypothesis, a huge statistical mistake. The third concern is claiming that the two treatments are equivalent which is a false conclusion. For three reasons:

1. The way the trial was designed implies a hypothesis of “ gamma nail is not superior”, this make the null hypothesis “there is no difference” which was the hypothesis the authors tested and failed to reject. That means It could be equal or inferior.

2. The statistical test the authors used was a two tailed chi-squared test. Its bi-directional not uni-directional. That means again it could be better or worse.

3. Equivalence trails, when failing to reject the null hypothesis means that it could be worse or better but not equivalent, unlike non-inferiority designs when superiority can be claimed (3).

I believe no conclusions can be drawn from this study due to huge methodological errors.

References

1. Hwang IK, Morikawa T. Design issues in oninferiority/equivalence trials. J Drug Info. 1999;33:1205-18.

2. Greene WL, Concato J, Feinstein AR. Claims of equivalence in medical research: are they supported by the evidence? Ann Intern Med. 2000;132:715-22.

3. Jones B, Jarvis P, Lewis JA, Ebbutt AF. Trials to assess equivalence: the importance of rigorous methods. BMJ. 1996;313:36-9.

Tristan M. Barton, MBChB, MSc

Posted on July 02, 2010

Mr. Barton and Mr. Chesser respond to Mr. Dean and colleagues

Department of Trauma and Orthopaedics, Frenchay Hospital, Bristol, United Kingdom

Thank you for your letter regarding the sub-classification of the AO/OTA 31-A2 proximal femoral fractures in our study. We did not sub-classify 31-A2 fractures, although we recognize that opinions do vary as to the appropriate treatment of the 31-A2.1, A2.2 and A2.3 sub-groups. The evidence for us not using the sub-classification system was based on a publication in 2002 by Parker et al. (1). This paper concluded that the AO classification with subgroups was not an acceptable classification system for trochanteric hip fractures due to poor inter- and intra- observer reliability.

Reference

1. Pervez H, Parker MJ, Pryor GA, Lutchman L, Chirodian N. Classification of trochanteric fracture of the proximal femur: a study of the reliability of current systems. Injury. 2002;33:713-5.

Benjamin Dean

Posted on June 23, 2010

Sub-classification

NHS

To the Editor:

I read the recent paper, "A comparison of the long gamma nail with the sliding hip screw for the treatment of AO/OTA 31-A2 fractures of the proximal part of the femur: a prospective randomized trial", by Barton et al. (2010;92:792-8) with great interest as the treatment of 31-A2 fractures frequently attracts a great deal of controversy. AO 31-A2 fractures can be further sub-classified into types A2.1, A2.2 and A2.3. A2.1 type fractures are stable after reduction, whilst A2.2 and A2.3 are multifragmentary fractures which are unstable after reduction. I would be interested to know if the patients' fractures in this study could be further sub-classified into the A2.1, A2.2 and A2.3 types? It would be interesting to know how many A2.2 and A2.3 fractures were treated as their treatment is particularly controversial.

The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity.

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Tristan M. Barton, Robert Gleeson, Claire Topliss, Rosemary Greenwood, William J. Harries, Timothy J.S. Chesser; A Comparison of the Long Gamma Nail with the Sliding Hip Screw for the Treatment of AO/OTA 31-A2 Fractures of the Proximal Part of the FemurA Prospective Randomized Trial. The Journal of Bone & Joint Surgery. 2010 Apr;92(4):792-798.

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