The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures

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1 Trauma The standard Gamma nail or the Medoff sliding plate for unstable trochanteric and subtrochanteric fractures A RANDOMISED, CONTROLLED TRIAL R. Miedel, S. Ponzer, H. Törnkvist, A. Söderqvist, J. Tidermark From The Stockholm Söder Hospital, Stockholm, Sweden R. Midel, MD, Consultant Orthopaedic Surgeon S. Ponzer, MD, PhD, Consultant Orthopaedic Surgeon H. Törnkvist, MD, PhD, Consultant Orthopaedic Surgeon A. Söderqvist, RN J. Tidermark, MD, PhD, Consultant Orthopaedic Surgeon Department of Orthopaedics, Karolinska Institutet, Stockhom Söder Hospital, S , Stockholm, Sweden. Correspondence should be sent to Dr J. Tidermark British Editorial Society of Bone and Joint Surgery doi: / x.87b $2.00 J Bone Joint Surg [Br] 2005;87-B: Received 12 January 2004; Accepted after revision 17 February 2004 We studied 217 patients with an unstable trochanteric or subtrochanteric fracture who had been randomly allocated to treatment by either internal fixation with a standard Gamma nail (SGN) or a Medoff sliding plate (MSP, biaxial dynamisation mode). Their mean age was 84 years (65 to 99) and they were reviewed at four and 12 months after surgery. Assessments of outcome included general complications, technical failures, revision surgery, activities of daily living (ADL), hip function (Charnley score) and the health-related quality of life (HRQOL, EQ-5D). The rate of technical failure in patients with unstable trochanteric fractures was 6.5% (6/ 93) (including intra-operative femoral fractures) in the SGN group and 5.2% (5/96) in the MSP group. In patients with subtrochanteric fractures, there were no failures in the SGN group (n = 16) and two in the MSP group (n = 12). In the SGN group, there were intraoperative femoral fractures in 2.8% (3/109) and no post-operative fractures. There was a reduced need for revision surgery in the SGN group compared with the MSP group (8.3%; 9/108; p = 0.072). The SGN group also showed a lower incidence of severe general complications (p < 0.05) and a trend towards a lower incidence of wound infections (p = 0.05). There were no differences between the groups regarding the outcome of ADL, hip function or the HRQOL. The reduction in the HRQOL (EQ-5D index score) was significant in both groups compared with that before the fracture (p < 0.005). Our findings indicate that the SGN showed good results in both trochanteric and subtrochanteric fractures. The limited number of intra-operative femoral fractures did not influence the outcome or the need for revision surgery. Moreover, the SGN group had a reduced number of serious general complications and wound infections compared with the MSP group. The MSP in the biaxial dynamisation mode had a low rate of failure in trochanteric fractures but an unacceptably high rate when used in the biaxial dynamisation mode in subtrochanteric fractures. The negative influence of an unstable trochanteric or subtrochanteric fracture on the quality of life was significant regardless of the surgical method. The treatment of stable trochanteric fractures of type 1 or type 2 according to the classification of Jensen and Michaelsen (J-M) 1 is uncontroversial and good results can be expected with various implants. 2 Most authors favour the sliding hip screw (SHS) and recent studies on this method have shown rates of failure below 2%. 3,4 In the case of unstable trochanteric fractures (J-M type 3 to 5) 1 and subtrochanteric fractures, 5 the treatment is more controversial and the rate of failure for the SHS in these fractures is considerably higher, ranging from 4% to 15%. 3,4,6-9 The Medoff sliding plate (MSP) evolved from the SHS and gives axial compression along both the femoral neck (optional) and the femoral shaft. It has produced remarkably good results in prospective trials in both unstable trochanteric and subtrochanteric fractures with a rate of failure of 2% to 4%. 4,9-11 The cephalocondylar intramedullary nails have obvious theoretical advantages because of their improved biomechanics with a shorter lever arm leading to a more stable construct of the fracture. Furthermore, the percutaneous technique of insertion may result in less softtissue trauma and thereby reduce bleeding and the incidence of infection. One of the earliest cephalocondylar intramedullary nails, the standard Gamma nail (SGN), has been evaluated in several clinical trials, but the theoretical advantages have not been proved in clinical outcomes. 12 The main drawback has been intraand post-operative fractures of the femoral 68 THE JOURNAL OF BONE AND JOINT SURGERY

2 THE STANDARD GAMMA NAIL OR THE MEDOFF SLIDING PLATE FOR UNSTABLE TROCHANTERIC AND SUBTROCHANTERIC FRACTURES 69 Included: 217 Randomised, SGN: 109 Randomised, MSP: 108 Operated, SGN: 103 Different method: 6 (see text) Operated, MSP: 108 Deceased before 4-mth f-u: 11 Lost at 4-mth f-u: 11 Available at 4-mth f-u: 87 Deceased before 4-mth f-u: 22 Lost at 4-mth f-u: 5 Available at 4-mth f-u: 81 Fig. 1 Surgical outcome for the 217 patients (* accumulated figures for deceased patients at follow-up at 12 months; mth, month; f-u, follow-up). Deceased before 12-mth f-u: 24* Lost at 12-mth f-u: 3 None re-operated Deceased before 12-mth f-u: 31* Lost at 12-mth f-u: 3 2 patients re-operated (see text) Available at 12-mth f-u: 82 Available at 12-mth f-u: 74 Re-operated: 3/82 (3.7%) Not re-operated: 79/82 (96.3%) Re-operated: 7/74 (9.5%) Not re-operated: 67/74 (90.5%) shaft. However, many of these trials were performed by surgeons who were not experienced in the surgical technique and thus included the learning curve in the results Studies by those well experienced in the technique have given good results with a rate of failure of less than 2% for unstable trochanteric fractures and about 1% for intra- and post-operative fractures of the femoral shaft. 18 It has also been shown that intra-operative complications decline with increasing experience. 18 The health-related quality of life (HRQOL) of patients with fractures of the femoral neck has been well described and the impact of the injury on the quality of life, especially in those with a complication of fracture healing, is substantial The HRQOL for patients with trochanteric or subtrochanteric fractures has not been described on a longer time scale. We have used the MSP and SGN in clinical practice for several years, the MSP since 1992, including participation in the Swedish multicentre study, 9,22 and the SGN since In order to evaluate our results with the SGN, a randomisation vs the MSP seemed logical considering the good results previously reported. 4,9-11 Our aim therefore was to compare the outcome in patients with unstable trochanteric and subtrochanteric fractures randomised to internal fixation with the SGN or the MSP and also to describe the HRQOL in this group of patients with trochanteric and subtrochanteric fractures. Patients and Methods We included 217 patients (176 women, 81%), who had an acute unstable trochanteric (J-M type 3 to 5) 1 or subtrochanteric fracture 5 after a simple fall with a mean age of 84 years (65 to 99). Those with pathological fractures, rheumatoid arthritis or osteoarthritis were excluded. In addition, fractures extending more than 5 cm distal to the lesser trochanter were excluded. This was because if the MSP was to be used in such fractures the most proximal cortical bone screws would prevent sliding of the plate and, if the SGN was to be used, the length of the nail (200 mm) would be insufficient. The patients were randomised (sealed-envelope technique) to internal fixation by an SGN or an MSP. The study was conducted according to the Helsinki Declaration and the protocol was approved by the local Ethics Commit- VOL. 87-B, No. 1, JANUARY 2005

3 70 R. MIEDEL, S. PONZER, H. TÖRNKVIST, A. SÖDERQVIST, J. TIDERMARK tee. The patients who died or were lost to follow-up at each time interval are shown in Figure 1. Operative technique. Reduction and fixation of the fracture were carried out with the patient lying supine on a fracture table. The SGN (diameter 11 mm, length 200 mm, valgus bend 10, neck angle 125 or 130 ; Stryker Howmedica, Malmo, Sweden) was introduced percutaneously after reaming of the medullary canal to 13 mm distally and 17 mm proximally. The set screw (antirotation screw) and one distal locking screw were used in all cases. All surgeons were instructed to insert the nail by hand, never to use the hammer and not to use the awl before drilling for the distal locking screw, in order to minimise the risk of fracture of the femoral shaft. The MSP (neck angle 135, six-hole plate; Swemac, Linkoping, Sweden) was used in the biaxial dynamisation mode which allows sliding along both the femoral neck and shaft. In fractures proximal to the entry site of the plate barrel, the entry hole was enlarged up to 2.5 cm distally in order to allow axial compression. The reduction was categorised as good when the alignment was normal or in slight valgus in the anteroposterior (AP) view, less than 20 of angulation in the lateral view and no more than 4 mm of displacement of any fragment. The position of the screw within the femoral head was defined by two independent techniques. First, the femoral head was divided into three columns on the AP and lateral views to create nine zones. 23 A position in the inferior or middle third of the head in the AP view and the middle third of the head in the lateral view, as well as a posterior position if combined with a central position in the AP view, was categorised as good. 24 Secondly, the minimum tip-head circumference distance of the screw, corrected for 15% of magnification, was meassured in the AP and the lateral views. 6 All patients were given low-molecular-weight heparin (Fragmin, Pharmacia, Taby, Sweden) before and for approximately 10 to 14 days after operation and one dose (1.5 g) of cefuroxim (Zinacef; GlaxoSmithKline, Molndal, Sweden) before operation. Patients were mobilised with full weight-bearing as tolerated. The care programmes were identical except for the randomisation. Primary assessment and follow-up. The primary assessment included determination of the type of fracture according to Jensen and Michaelsen 1 for trochanteric fractures and according to Seinsheimer 5 for subtrochanteric fractures, comorbidity according to Ceder, Thorngren and Wallden 25 and cognitive function according to the short portable mental status questionnaire (SPMSQ). 26 The patients were interviewed about their living conditions, mobility, activities of daily living (ADL) 27 and HRQOL according to the EuroQol (EQ-5D) 28 during the last week before the fracture as baseline data. The mean operating time, the intra-operative blood loss, the need for blood transfusion, the experience of the surgeon and the total hospital stay were recorded. The patients were seen at four (mean 4.2, SD 1.1) and 12 (mean 13.0, SD 2.3) months for a clinical and radiological examination. General complications, technical failures, healing of the fracture, revision operations, hip function and the HRQOL were recorded. Comorbidity 25 was graded as follows: A, full health; B, another illness not affecting rehabilitation; and C, another illness affecting rehabilitation. The Katz ADL index 27 status is based on an evaluation of the functional independence or dependence of patients in bathing, dressing, going to the toilet, transferring, continence and feeding. Index A indicates independence in all six functions, index B independence in all but one of the six functions. Indices C to G indicate dependence in bathing and at least one other function. Technical failures were defined as penetration of the lag screw, excessive displacement, e.g. medialisation of the femoral shaft, breakage or loosening of the implant, intraor post-operative fracture of the femoral shaft or nonunion. Migration of the lag screw within the femoral head or varus angulation of the fracture without penetration of the lag screw was not regarded as a technical failure. The fracture was defined as healed if there were visible trabeculae across the fracture line. Nonunion was defined as an absence of radiographically visible trabeculae across the fracture line, including early redisplacement or progressive displacement. Deep wound infection (defined as established infection beneath the fascia requiring surgical revision), superficial wound infection (defined as cutaneous/subcutaneous infection requiring antibiotic therapy) and severe general complications (cardiac, pulmonary, thromboembolic or cerebrovascular) were noted. Charnley s numerical classification 29 defines the clinical state of the affected hip in three dimensions: pain at the hip, movement of the hip and walking ability. Each is graded from 1 to 6 (with 1 = total disability and 6 = the normal state). The HRQOL was rated using the EQ-5D. 28 The EQ-5D has five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension is divided into three degrees of severity: no problem, some problems and major problems. Dolan et al 30 used the time trade-off method to rate these different states of health in a large population in the UK (UK EQ-5D Index Tariff). We used the preference scores (EQ-5D index scores) generated from this population when calculating the scores for our study population. A value of 0 indicated the worst possible state of health and a value of 1 indicated full health. The HRQOL is only presented for patients without severe cognitive dysfunction (SPMSQ 3) since those with severe cognitive dysfunction are not able to answer the questionnaire properly In the analysis of outcome, all patients included remained in their primary group of randomisation according to the intention-to-treat principle. All clinical variables except hip movement were assessed by an unbiased observer (a research nurse not involved in the surgery or THE JOURNAL OF BONE AND JOINT SURGERY

4 THE STANDARD GAMMA NAIL OR THE MEDOFF SLIDING PLATE FOR UNSTABLE TROCHANTERIC AND SUBTROCHANTERIC FRACTURES 71 Table I. Baseline data for the 217 patients, by number and percentage SGN (n = 109) MSP (n = 108) p value Mean (SEM) age in years Mean (SEM) cognitive function (SPMSQ) Mean (SEM) EQ-5D index score prefracture* Number of women Mobility (no walking aid or just one stick) ADL indices A and B Comorbidity groups A and B From independent living * in patients with SPMSQ 3 Table II. Types of fracture according to the classification of Jensen and Michaelsen (J-M) 1 (trochanteric fractures) and of Seinsheimer 5 (subtrochanteric fractures) for the 217 patients by number and percentage SGN (n = 109) MSP (n = 108) Trochanteric fractures (n = 189) J-M J-M J-M Subtrochanteric fractures (n = 28) S2B S2C S3A S3B S S clinical decisions). The research nurse was not blinded to the type of surgical intervention. There were no significant differences between the SGN and MSP groups regarding the baseline data (Table I) or the type of fracture (Table II). There was a trend towards slightly older patients in the SGN group. Statistical analysis. The statistical software used was SPSS 11.5 for Windows (SPSS, Chicago, Illinois). The Mann- Whitney U test was used for scale variables and ordinal variables in independent groups. Nominal variables were tested by the chi-squared test or Fisher s exact test. A Wilcoxon signed-rank test was used to compare scores between the baseline and follow-up. A correlation analysis was performed using Spearman s rho test. All tests were two-sided. The results were considered to be significant at p < The trend values of 0.05 p < 0.1 are displayed; all other values are reported as not significant (ns). Results Operative data. Six patients in the SGN group were operated on using a method of variance with the randomisation (Fig. 1). Three of these sustained an intra-operative femoral fracture. In two this was caused by an inadequate surgical technique. In spite of the recommended operative technique, a hammer had been used during insertion of the nail in one patient and in the other a wrong entry point had been used leading to excessive force during insertion of the nail. The intra-operative fractures were all recognised during the primary procedure and the SGN was exchanged in all cases to a long gamma nail (LGN) with uneventful outcomes. In two patients an LGN had been used because of misinterpretation of the study protocol by the surgeons. Finally, in one case the surgeon considered open reduction to be necessary and therefore intra-operatively changed the SGN to an MSP. The experience of the surgeons did not differ between groups. Approximately 50% of the operations in both groups were performed by consultant orthopaedic surgeons. The mean operating time was 61 minutes (22 to 127) in the SGN group and 65 minutes (20 to 122) in the MSP group (ns). The intra-operative blood loss was 276 ml (50 to 1000) in the SGN group and 402 ml (25 to 2400) in the MSP group (p < 0.01). The amount of blood transfused was 864 ml (0 to 2700) in the SGN group and 800 ml (0 to 3000) in the MSP group (ns). The reduction and screw position were assessed when the study was concluded and the primary post-operative radiographs were retrieved in 195 patients. In the SGN group, the reduction was considered to be good in 63% (60/95) of the patients as compared with 40% (40/100) in the MSP group (p < 0.005). In six of nine patients undergoing a revision operation because of technical failure (the primary post-operative radiographs were not retrievable in one case), the reduction was not considered to be good (p = 0.074). The position of the screw was considered to be good in 92% (87/95) of the SGN group and 93% (93/100) of the MSP group (ns). There was a trend towards more frequent revisions because of technical failures in patients with an unacceptable position of the screw (p = 0.094). The mean minimum tip-head circumference distance of the screw was 6 mm (1 to 14) in the SGN group and 7 mm (1 to 18) in the MSP group (p = 0.099). There was no correlation between this difference in distance and the need for revision due to technical failure. The mean total stay on the orthopaedic ward was six days in both groups. In the SGN group, 7% (8/109) went back home, 81% (88/109) to orthopaedic rehabilitation, 11% (12/109) to a nursing home and 1% (1/109) died during their stay in hospital. In the MSP group, 11% (12/108) went back home, 75% (81/108) to orthopaedic rehabilitation, 7% (8/108) to a nursing home and 7% (7/108) died during their stay in hospital (p = 0.094). VOL. 87-B, No. 1, JANUARY 2005

5 72 R. MIEDEL, S. PONZER, H. TÖRNKVIST, A. SÖDERQVIST, J. TIDERMARK Table III. Technical failures with reference to the type of fracture, unstable trochanteric or subtrochanteric by number and percentage SGN (n = 109) MSP (n = 108) Trochanteric fractures (n = 189) No complication Penetration of lag screw Redisplacement/medialisation Intra-operative femoral fracture Subtrochanteric fractures (n = 28) No complication Penetration of lag screw Redisplacement/medialisation Intra-operative femoral fracture General complications. Severe general complications, including deaths, before the four-month follow-up were more frequent in the MSP group (p < 0.05). The mortality rate in the SGN group was 10% (11/109), and 3% (3/109) of the patients had another severe complication (cardiac, pulmonary, thromboembolic or cerebrovascular) compared with 20% (22/108) and 4% (4/108), respectively, in the MSP group. Surgical outcome The surgical outcome is presented in Figure 1. The number of technical failures did not differ between groups as shown in Table III. The three patients in the MSP group with redisplacement/medialisation had radiologically excessive medialisation of the femoral shaft and severe pain at the hip making walking impossible. In the MSP group one patient with a minor penetration of the lag screw declined further surgery and another (case 91) with a radiologically healed fracture had the implant removed after ten months because of local pain. After a few weeks a stress fracture in the femoral neck was diagnosed and the patient underwent revision to a total hip replacement (THR) with an uneventful outcome. This case was not included among the technical failures in the MSP group. There was a trend towards more frequent revisions in the MSP group (Table IV). The total number of patients requiring re-operation was three of 109 (2.8%) in the SGN group and nine of 108 (8.3%) in the MSP group (p = 0.072). The revision rate in unstable trochanteric fractures was three of 93 (3.2%) in the SGN group and six of 96 (6.3%) in the MSP group (ns). Regarding subtrochanteric fractures, there were no revisions in the SGN group (n = 16) as compared with three (two, technical failure; one, deep infection) in the MSP group (n = 12) (p = 0.067). Healing of the fracture was demonstrated radiographically at the final follow-up in 136 of 146 available patients and clinically in the rest. There were no post-operative fractures of the femoral shaft in either group during the 12-month follow-up period. There was a trend towards more frequent post-operative infections in the MSP group (p = 0.05). There were six superficial wound infections in the MSP group as compared with two in the SGN group. Furthermore, there were two deep wound infections in the MSP group, one leading to a Girdlestone arthroplasty and the subsequent death of a 94- year old woman (case 219) and one leading to multiple revisions but finally a healed fracture in a 91-year old woman (case 43) (Table IV). Functional outcome and HRQOL. There were no significant differences in the ADL between the groups at any of the follow-up examinations. At four months, 49% (43/87) in the SGN group and 60% (49/81) in the MSP group were categorised as indices A and B; at 12 months, the figures were 57% (47/82) and 63% (47/74), respectively. Hip function (Table V) and the HRQOL according to the EQ- 5D (Fig. 2) did not differ between the groups at any of the follow-up examinations. The reduction in the HRQOL Table IV. Details of the 12 patients who had revision Case number Randomisation* Indication Re-operation Time from primary operation (mths) Fracture type 43 MSP Deep infection Multiple revisions, healed fx 1.6 S5 at 12 months 59 SGN L-S penetration THR 3.6 J-M 3 68 MSP L-S penetration Girdlestone arthroplasty 3.4 J-M 4 Lost at 12-month follow-up 91 MSP 1) Local pain 1) Extraction of MSP 1) 10.3 J-M 5 2) Stress fx in the femoral neck 2) THR 2) MSP L-S penetration THR 5.8 J-M SGN L-S penetration THR 4.4 J-M MSP L-S penetration THR 1.3 J-M SGN L-S penetration THR 12.1 J-M MSP Redisplacement, medialisation 1) DCS 1) 1.0 S2C 2) THR 2) MSP Redisplacement, medialisation LGN 0.4 S2C 169 MSP Redisplacement, medialisation PFN 0.5 J-M MSP Deep infection Girdlestone arthroplasty Deceased after 2.8 mths 1.0 J-M 5 * SGN, standard gamma nail; MSP, Medoff sliding plate lag-screw fx, fracture; DCS, dynamic compression screw; PFN, proximal femoral nail; LGN, long gamma nail; THR, total hip replacement J-M, Jensen and Michaelsen 1 (trochanteric); S, Seinsheimer 5 subtrochanteric THE JOURNAL OF BONE AND JOINT SURGERY

6 THE STANDARD GAMMA NAIL OR THE MEDOFF SLIDING PLATE FOR UNSTABLE TROCHANTERIC AND SUBTROCHANTERIC FRACTURES 73 EQ-5D index score Table V. Hip function according to the Charnley score (mean) for patients available at each follow-up SGN MSP Pain 4 mths (n = 163) mths (n = 155) Movement of hip 4 mths (n = 153) mths (n = 152) Walking ability 4 mths (n = 165) mths (n = 155) All patients before fracture MSP SGN Before fracture At 4 mths At 12 mths Time Fig. 2 The HRQOL (EQ-5D) for all patients without severe cognitive dysfunction (SPMSQ 3) before fracture and at each follow-up (162 at inclusion, 142 at four months, and 134 at 12 months). (EQ-5D index score) between prefracture and both follow-up examinations was highly significant in both groups (p < 0.005). Discussion The findings of our study show generally good results with both the SGN and MSP in patients with unstable trochanteric fractures with technical rates of failure of 6.5% and 5.2%, respectively. However, in the smaller group of subtrochanteric fractures, there were no failures in the SGN group as compared with two of 12 in the MSP group, both due to pronounced medialisation of the femoral shaft. There was a trend towards a decreased number of revisions in the SGN group (2.8%) compared with the MSP group (8.3%). The SGN group also showed a lower incidence of severe general complications and a lower incidence of wound infections. There was no difference regarding the outcome in AFDL, hip function (Charnley score) or HRQOL (EQ-5D). The results with the SGN compare favourably with those of previous reports on the SHS 3,4,7-9,31 and are comparable with those previously reported with the MSP. 4,9-11 The main problem remains the risk of intra-operative fractures, 3/109 (2.75%) in our study, although, in most cases, they were induced by inappropriate surgical technique. All the intra-operative fractures were detected during the primary procedure and the fixation was easily converted to an LGN. Consequently, this technical problem did not necessitate any secondary revision procedures. The absence of postoperative femoral fractures during the follow-up period of 12 months suggests that some of the previously reported early fractures of the femoral shaft were, in fact, unrecognised intra-operative fractures. The reason for the overall limited number of femoral fractures could be related to the use of nails of small diameter (11 mm), over-reaming of the medullary canal by 2 mm and an atraumatic surgical technique, which was not applied in a few cases. The SGN seemed to maintain the reduction better than the MSP in contrast to the findings in most previous studies. 6,13,32 The position of the lag screws in the femoral head was equally good in the SGN group as in the MSP group, perhaps reflecting the participating surgeons experience in the nailing technique. Surgeons experienced in the technique for inserting the lag screw in the SHS or MSP are used to positioning the lag screw initially in an optimal position and then applying the plate. The technique for cephalocondylar intramedullary nails is quite different since the procedure starts with inserting a nail with a fixed neck angle and then inserting the lag screw. If an optimal position of the guide-wire is not achieved after proper insertion of the nail, the surgeon has to improve the reduction or change to a nail with a different neck angle. This may induce some surgeons to accept a suboptimal position of the lag screw. An implant with an inherent risk of femoral fractures is not ideal. This risk may be due to the specific design of the SGN and not to the general concept of cephalocondylar intramedullary nails. The length of the nail (200 mm) in combination with 10 of valgus creates three-point fixation of the non-elastic implant within the proximal femur, leading to a stress concentration at the distal part of the implant. 33,34 Modifications of the design may lead to further improvement of the results. Studies on the more recently introduced intramedullary hip screw (Smith & Nephew, Molndal, Sweden) have not shown any substantial improvement with a rate of intra-operative fractures in the range of 2% to 3% and of post-operative fractures of 0% to 6%. 35,36 In a recently published prospective study on 55 patients with unstable trochanteric fractures treated with the proximal femoral nail (Stratec Medical, Solna, Sweden) there were no intra- or post-operative femoral fractures. 37 Leung et al 38 reported no femoral fractures in a study with a modified Gamma nail with a length of 180 mm and only 4 of valgus bend and later reported a multicentre study using the same implant in which the total rate of fractures of the femoral shaft was 2.5% (1.1% intra-operative and 1.4% post-operative). 39 The increased number of complications in the multicentre study was explained by the fact VOL. 87-B, No. 1, JANUARY 2005

7 74 R. MIEDEL, S. PONZER, H. TÖRNKVIST, A. SÖDERQVIST, J. TIDERMARK that the learning curve was included in the results at some participating institutions. This modified Gamma nail very much resembles the recently introduced trochanteric Gamma nail (Stryker Howmedica). Good results with the MSP used in biaxial dynamisation mode in unstable trochanteric fractures was confirmed in our study. The rate of failure of 5.5% compares favourably with that in previous studies on the SHS 3,4,6-9 and is somewhat better than the 6.7% reported for the MSP in the Swedish multicentre study, 22 but not as good as the 2.0% reported by Lunsjö et al 10 or the 3.8% reported by Watson et al. 4 For the limited group of subtrochanteric fractures, the rate of failure was surprisingly high for the MSP. The two revisions because of technical failures were due to excessive medialisation in patients with Seinsheimer type-s 2C fractures, 5 also referred to as the reversed oblique subtrochanteric fracture. The explanation may be that the MSP was used in biaxial dynamisation mode. Lunsjö et al 9 reported a rate of technical failure of only 1.8% in subtrochanteric fractures when the MSP was used in uniaxial dynamisation mode. However, uniaxial dynamisation requires frequent radiological follow-up and readiness for staged dynamisation in a number of cases in order to prevent penetration of the lag screw. 11 Furthermore, in clinical practice, the differentiation between low trochanteric fractures and high subtrochanteric fractures may be difficult and lead to erroneous uniaxial dynamisation in trochanteric fractures. This was the situation in the Swedish multicentre study 22 in which the locking set screw was erroneously used in 29 of 268 patients and contributed to penetration of the lag screw in nine. The suboptimal results of uniaxial dynamisation in unstable trochanteric fractures was also demonstrated in an early study by Lunsjö et al 40 with a rate of penetration of the lag screws of 6.7%. In order partly to overcome this, a shorter four-hole MSP was introduced with obligatory biaxial dynamisation, 41 but the problem of correct interpretation and classification of the type of fracture in clinical practice still remains. The theoretical advantages of the percutaneously inserted SGN seemed to be partly confirmed in our study with less intra-operative bleeding, although not confirmed by a reduced need for transfusion, fewer severe general complications and fewer wound infections. The fewer general complications is noteworthy inasmuch as the randomisation resulted in a trend towards slightly older patients in the SGN group, 84.6 years compared with 82.7 years. The most probable explanation of these findings is the less extensive surgical trauma with the cephalocondylar intramedullary nails. The patients with penetration of the lag screw were successfully treated by THR with the exception of one, a woman with severe dementia from a nursing home who required a Girdlestone arthroplasty. In our experience, a THR should be used in most cases of penetration of the lag screw since conversion to another type of internal fixation is rarely successful in elderly osteoporotic patients. Two of three patients with excessive medialisation after an MSP were successfully treated by a cephalocondylar intramedullary nail. In the third case, revision to a dynamic compression screw (Stratec) was undertaken but a THR was eventually required. There were no differences regarding the outcome as assessed by ADL, hip function (Charnley hip score) or the HRQOL (EQ-5D), perhaps implying that the main focus for improving the treatment should be on reducing the number of technical failures, especially those leading to revision surgery. The mean prefracture EQ-5D index score in the patients without severe cognitive dysfunction was 0.64, which is lower than for a comparable group of patients with fracture of the femoral neck 20 in which it was This probably reflects the more advanced age and more frequent comorbidities in patients with trochanteric fractures. The decrease in the mean EQ-5D index score one year after treatment was 0.15, which is a substantial deterioration. For comparison, patients without severe cognitive dysfunction, with undisplaced or displaced fracture of the femoral neck treated by internal fixation had a reduction of the mean EQ-5D index score during the first year after surgery of 0.10 and 0.22, respectively. 21 The quality of life instrument, EQ-5D, is brief and easy to use in elderly patients 20,42 and has been validated in patients with fracture of the hip. 43,44 It also allows the combination of different dimensions of health to form an overall index, as required for health-care evaluations. 45 The patients ability to recall correctly the state of their health before the fracture may be questioned. However, since a prospective collection of HRQOL baseline data for a specific population is impossible, the alternative methods often used are recall of the pre-injury state, as in this and other trauma studies, 19,20,46 and/or the use of population values. Our study has some limitations. First, in spite of the power analysis before the study, it was underpowered. Some of the differences regarding failure and revision rates, especially in the smaller group of subtrochanteric fractures, did not reach statistical significance. On the other hand, the differences in absolute numbers were small in the group of trochanteric fractures and the sample size required to secure differences statistically would have probably exceeded that which is possible to collect at one institution. Secondly, six patients in the SGN group were operated on by a method at variance with the randomisation. We believe that keeping these patients in the intention-to-treat analysis was more appropriate than excluding them. Finally, there was a small number of patients lost to followup at the follow-up at 12 months (2.8%; 6/217; Fig. 1) but this should not affect the interpretation of the results. In conclusion, use of the SGN gave good results in both trochanteric and subtrochanteric fractures. The limited number of intra-operative femoral fractures did not influence the outcome or require further procedures. Moreover, the group with an SGN showed a reduced number of seri- THE JOURNAL OF BONE AND JOINT SURGERY

8 THE STANDARD GAMMA NAIL OR THE MEDOFF SLIDING PLATE FOR UNSTABLE TROCHANTERIC AND SUBTROCHANTERIC FRACTURES 75 ous general complications and wound infections compared with the MSP group. The MSP in the biaxial dynamisation mode had a low rate of failure in trochanteric fractures but an unacceptably high rate when used in the biaxial dynamisation mode in subtrochanteric fractures. The negative influence of an unstable trochanteric or subtrochanteric fracture on the quality of life was substantial regardless of the choice of implant. In our opinion, there is room for improvement in the operative technique and design of cephalointramedullary nails. This study was supported in part by grants from the Trygg-Hansa Insurance Company, the Swedish Orthopaedic Association and, in equal parts, from Stryker Howmedica, Sweden (SGN), and Swemac, Sweden (MSP). 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