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The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 8 | Pages 1073 - 1078
1 Aug 2008
Little NJ Verma V Fernando C Elliott DS Khaleel A

We compared the outcome of patients treated for an intertrochanteric fracture of the femoral neck with a locked, long intramedullary nail with those treated with a dynamic hip screw (DHS) in a prospective randomised study.

Each patient who presented with an extra-capsular hip fracture was randomised to operative stabilisation with either a long intramedullary Holland nail or a DHS. We treated 92 patients with a Holland nail and 98 with a DHS. Pre-operative variables included the Mini Mental test score, patient mobility, fracture pattern and American Society of Anesthesiologists grading. Peri-operative variables were anaesthetic time, operating time, radiation time and blood loss. Post-operative variables were time to mobilising with a frame, wound infection, time to discharge, time to fracture union, and mortality.

We found no significant difference in the pre-operative variables. The mean anaesthetic and operation times were shorter in the DHS group than in the Holland nail group (29.7 vs 40.4 minutes, p < 0.001; and 40.3 vs 54 minutes, p < 0.001, respectively). There was an increased mean blood loss within the DHS group versus the Holland nail group (160 ml vs 78 ml, respectively, p < 0.001). The mean time to mobilisation with a frame was shorter in the Holland nail group (DHS 4.3 days, Holland nail 3.6 days, p = 0.012). More patients needed a post-operative blood transfusion in the DHS group (23 vs seven, p = 0.003) and the mean radiation time was shorter in this group (DHS 0.9 minutes vs Holland nail 1.56 minutes, p < 0.001). The screw of the DHS cut out in two patients, one of whom underwent revision to a Holland nail. There were no revisions in the Holland nail group. All fractures in both groups were united when followed up after one year.

We conclude that the DHS can be implanted more quickly and with less exposure to radiation than the Holland nail. However, the resultant blood loss and need for transfusion is greater. The Holland nail allows patients to mobilise faster and to a greater extent. We have therefore adopted the Holland nail as our preferred method of treating intertrochanteric fractures of the hip.


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_4 | Pages 4 - 4
8 Feb 2024
Oliver WM Bell KR Carter TH White TO Clement ND Duckworth AD Molyneux SG
Full Access

This single-centre prospective randomised trial aimed to assess the superiority of operative fixation compared with non-operative management for adults with an isolated, closed humeral shaft fracture. 70 patients were randomly allocated to either open reduction and internal fixation (51%, n=36/70) or functional bracing (49%, n=34/70). 7 patients did not receive their assigned treatment (operative n=5/32, non-operative n=2/32); results were analysed based upon intention-to-treat. The primary outcome measure was the DASH score at 3 months. Secondary outcomes included treatment complications, union/nonunion, shoulder/elbow range of motion, pain and health-related quality of life (HRQoL). At 3 months, 66 patients (94%) were available for follow-up; the mean DASH favoured surgery (operative 24.5, non-operative 39.4; p=0.006) and the difference (14.9 points) exceeded the MCID. Surgery was also associated with a superior DASH at 6wks (operative 38.4, non-operative 53.1; p=0.005) but not at 6 months or 1yr. Brace-related dermatitis affected 7 patients (operative 3%, non-operative 18%; OR 7.8, p=0.049) but there were no differences in other complications. 8 patients (11%) developed a nonunion (operative 6%, non-operative 18%; OR 3.8, p=0.140). Surgery was associated with superior early shoulder/elbow range of motion, and pain, EuroQol and SF-12 Mental Component Summary scores. There were no other differences in outcomes between groups. Surgery confers early advantages over bracing, in terms of upper limb function, shoulder/elbow range of motion, pain and HRQoL. However, these benefits should be considered in the context of potential operative risks and the absence of any difference in patient-reported outcomes at 1yr


The Bone & Joint Journal
Vol. 99-B, Issue 7 | Pages 964 - 972
1 Jul 2017
Duckworth AD Clement ND McEachan JE White TO Court-Brown CM McQueen MM

Aims

The aim of this prospective randomised controlled trial was to compare non-operative and operative management for acute isolated displaced fractures of the olecranon in patients aged ≥ 75 years.

Patients and Methods

Patients were randomised to either non-operative management or operative management with either tension-band wiring or fixation with a plate. They were reviewed at six weeks, three and six months and one year after the injury. The primary outcome measure was the Disabilities of the Arm, Shoulder and Hand (DASH) score at one year.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_18 | Pages 3 - 3
1 Nov 2017
Duckworth A Clement N White T Court-Brown C McQueen M
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The aim of this prospective randomized controlled trial was to compare patient reported and functional outcomes, complications and costs for displaced olecranon fractures managed with either tension band wire (TBW) or plate fixation. We performed a registered prospective randomized, single blind, single centre trial in 67 patients aged between 16–74 years with an acute isolated displaced fracture of the olecranon. Patients were randomised to either TBW (n=34) or plate fixation (n=33). The primary outcome measure was the Disability Arm Shoulder and Hand (DASH) score at one-year.

The baseline demographic and fracture characteristics of the two groups were overall comparable. The one-year follow-up was 85percnt;. There was a significant improvement in elbow function over the 12 months following injury in both groups (p<0.001). At one-year following surgery the DASH for the TBW group was not statistically different to the plate fixation group (12.8 vs 8.5; p=0.315). There was no significant difference between groups in terms of range of movement, Broberg and Morrey Score, Mayo Elbow Score or the DASH at all assessment points over the one-year following injury (all p≥0.05). Complication rates were significantly higher in the TBW group (63percnt;vs38percnt;; p=0.042), predominantly due to a significantly higher rate of symptomatic metalwork removal (50percnt;vs22percnt;; p=0.021).

In active patients with an isolated displaced fracture of the olecranon, no difference was found in the patient reported outcome between TBW and plate fixation at one year following surgery. The complication rate is higher following TBW fixation due to a high rate of symptomatic metalwork removal.


The Bone & Joint Journal
Vol. 96-B, Issue 4 | Pages 548 - 554
1 Apr 2014
Sun H Luo CF Zhong B Shi HP Zhang CQ Zeng BF

Our aim was to compare polylevolactic acid screws with titanium screws when used for fixation of the distal tibiofibular syndesmosis at mid-term follow-up. A total of 168 patients, with a mean age of 38.5 years (18 to 72) who were randomly allocated to receive either polylevolactic acid (n = 86) or metallic (n = 82) screws were included. The Baird scoring system was used to assess the overall satisfaction and functional recovery post-operatively. The demographic details and characteristics of the injury were similar in the two groups. The mean follow-up was 55.8 months (48 to 66). The Baird scores were similar in the two groups at the final follow-up. Patients in the polylevolactic acid group had a greater mean dorsiflexion (p = 0.011) and plantar-flexion of the injured ankles (p < 0.001). In the same group, 18 patients had a mild and eight patients had a moderate foreign body reaction. In the metallic groups eight had mild and none had a moderate foreign body reaction (p <  0.001). In total, three patients in the polylevolactic acid group and none in the metallic group had heterotopic ossification (p = 0.246).

We conclude that both screws provide adequate fixation and functional recovery, but polylevolactic acid screws are associated with a higher incidence of foreign body reactions.

Cite this article: Bone Joint J 2014;96-B:548–54.


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 2 | Pages 183 - 188
1 Mar 2002
Rogmark C Carlsson Å Johnell O Sernbo I

It remains a matter of debate whether displaced fractures of the neck of the femur should be treated by internal fixation or arthroplasty. We have compared the two methods with regard to complications, mortality and functional outcome.

We studied 409 patients, aged 70 years and over, with subcapital fractures graded as Garden 3 or 4, in a two-year prospective multicentre study from 12 Swedish hospitals. They were randomised to internal fixation or arthroplasty. Patients who were mentally confused, bedridden or in a nursing-home were excluded from the survey.

After two years the rate of failure was 43% in the internal fixation (IF) and 6% in the arthroplasty group (p < 0.001). In the IF group 36% had impaired walking and 6% had severe pain compared with 25% and 1.5%, respectively, in the arthroplasty group (both p < 0.05). There was no difference in mortality.

With a high rate of failure and poor functional outcome after IF, we recommend primary arthroplasty for displaced fractures of the neck of the femur in patients over 70 years of age.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 7 | Pages 984 - 988
1 Jul 2010
Guo JJ Tang N Yang HL Tang TS

We compared the outcome of closed intramedullary nailing with minimally invasive plate osteosynthesis using a percutaneous locked compression plate in patients with a distal metaphyseal fracture in a prospective study.

A total of 85 patients were randomised to operative stabilisation either by a closed intramedullary nail (44) or by minimally invasive osteosynthesis with a compression plate (41). Pre-operative variables included the patients’ age and the side and pattern of the fracture. Peri-operative variables were the operating time and the radiation time. Postoperative variables were wound problems, the time to union of the fracture, the functional American Orthopaedic Foot and Ankle surgery score and removal of hardware.

We found no significant difference in the pre-operative variables or in the time to union in the two groups. However, the mean radiation time and operating time were significantly longer in the locked compression plate group (3.0 vs 2.12 minutes, p < 0.001, and 97.9 vs 81.2 minutes, p < 0.001, respectively). After one year, all the fractures had united. Patients who had intramedullary nailing had a higher mean pain score, but better function, alignment and total American Orthopaedic Foot and Ankle surgery scores, although the differences were not statistically significant (p = 0.234, p = 0.157, p = 0.897, p = 0.177 respectively). Three (6.8%) patients in the intramedullary nailing group and six (14.6%) in the locked compression plate group showed delayed wound healing, and 37 (84.1%) in the former group and 38 (92.7%) in the latter group expressed a wish to have the implant removed.

We conclude that both closed intramedullary nailing and a percutaneous locked compression plate can be used safely to treat Orthopaedic Trauma Association type-43A distal metaphyseal fractures of the tibia. However, closed intramedullary nailing has the advantage of a shorter operating and radiation time and easier removal of the implant. We therefore prefer closed intramedullary nailing for patients with these fractures.


Full Access

This prospective randomised trial aimed to assess the superiority of internal fixation of well-reduced medial malleolar fractures (displacement □2mm) compared with non-fixation, following fibular stabilisation in patients undergoing surgical management of a closed unstable ankle fracture. A total of 154 adult patients with a bi- or trimalleolar fracture were recruited from a single centre. Open injuries and vertically unstable medial malleolar fractures were excluded. Following fibular stabilisation, patients were randomised intra-operatively on a 1:1 basis to fixation or non-fixation after satisfactory fluoroscopic fracture reduction was confirmed. The primary outcome was the Olerud Molander Ankle Score (OMAS) at 12 months post-randomisation. Complications were documented over the follow-up period. The baseline group demographics and injury characteristics were comparable. There were 144 patients reviewed at the primary outcome point (94%). The median OMAS was 80 (IQR, 60-90) in the fixation group vs. 72.5 (IQR, 55-90) in the non-fixation group (p=0.165). Complication rates were comparable, although significantly more patients (n=13, 20%) in the non-fixation group developed a radiographic non-union (p<0.001). The majority (n=8/13) were asymptomatic, with one patient requiring surgical reintervention. In the non-fixation group, a superior outcome was associated with an anatomical medial malleolar fracture reduction. Internal fixation is not superior to non-fixation of well-reduced medial malleolar fractures when managing unstable ankle fractures. However, one in five patients following non-fixation developed a radiographic non-union and whilst the re-intervention rate to manage this was low, the longer-term consequences of this are unknown. The results of this trial may support selective non-fixation of anatomically reduced fractures


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1723 - 1734
1 Dec 2020
Fung B Hoit G Schemitsch E Godbout C Nauth A

Aims. The purpose of this study was to: review the efficacy of the induced membrane technique (IMT), also known as the Masquelet technique; and investigate the relationship between patient factors and technique variations on the outcomes of the IMT. Methods. A systematic search was performed in CINAHL, The Cochrane Library, Embase, Ovid MEDLINE, and PubMed. We included articles from 1 January 1980 to 30 September 2019. Studies with a minimum sample size of five cases, where the IMT was performed primarily in adult patients (≥ 18 years old), in a long bone were included. Multivariate regression models were performed on patient-level data to determine variables associated with nonunion, postoperative infection, and the need for additional procedures. Results. A total of 48 studies were included, with 1,386 cases treated with the IMT. Patients had a mean age of 40.7 years (4 to 88), and the mean defect size was 5.9 cm (0.5 to 26). In total, 82.3% of cases achieved union after the index second stage procedure. The mean time to union was 6.6 months (1.4 to 58.7) after the second stage. Our multivariate analysis of 450 individual patients showed that the odds of developing a nonunion were significantly increased in those with preoperative infection. Patients with tibial defects, and those with larger defects, were at significantly higher odds of developing a postoperative infection. Our analysis also demonstrated a trend towards the inclusion of antibiotics in the cement spacer having a protective effect against the need for additional procedures. Conclusion. The IMT is an effective management strategy for complex segmental bone defects. Standardized reporting of individual patient data or larger prospective trials is required to determine the optimal implementation of this technique. This is the most comprehensive review of the IMT, and the first to compile individual patient data and use regression models to determine predictors of outcomes. Cite this article: Bone Joint J 2020;102-B(12):1723–1734


Bone & Joint Open
Vol. 5, Issue 11 | Pages 962 - 970
4 Nov 2024
Suter C Mattila H Ibounig T Sumrein BO Launonen A Järvinen TLN Lähdeoja T Rämö L

Aims

Though most humeral shaft fractures heal nonoperatively, up to one-third may lead to nonunion with inferior outcomes. The Radiographic Union Score for HUmeral Fractures (RUSHU) was created to identify high-risk patients for nonunion. Our study evaluated the RUSHU’s prognostic performance at six and 12 weeks in discriminating nonunion within a significantly larger cohort than before.

Methods

Our study included 226 nonoperatively treated humeral shaft fractures. We evaluated the interobserver reliability and intraobserver reproducibility of RUSHU scoring using intraclass correlation coefficients (ICCs). Additionally, we determined the optimal cut-off thresholds for predicting nonunion using the receiver operating characteristic (ROC) method.


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 273 - 273
1 Sep 2012
Lazennec JY Rakover JP Aaron A Pascal Mousselard H Rousseau MA
Full Access

Introduction. Current artificial discs include 1 or 2 bearing surfaces, providing 3 or 5 degrees of freedom. The ESP® is a one-piece e implant made of silicon and polycarbonate -urethane securely fixed to titanium endplates. It allows limited rotation and translation with elastic return. This cushion without fixed rotation center achieves 6 degrees of freedom including shock absorption. This objective of this study was to evaluate the safety and efficacy of the concept in a prospective nonrandomized trial. Material and methods. Prior to clinical implantations, the device was endurance tested at least 40 millions cycles. The polymer core weight and properties, the geometrical characteristics and cohesion of the implants remained stable. A prospective trial was initiated in 2004 for L3L4, L4L5 and L5S1 levels. Total disc replacements have been performed in 153 lumbar levels through extra-peritoneal mini-invasive anterior approach with a minimum 2 years follow-up. Results. There was no clinical or radiological device related complication, except 2 early revisions for post-traumatic implant migrations (8, 17 days post-op.). When comparing the device to other implants, clinically relevant improvements in VAS, SF-36 and ODI scores were observed. At ultimate follow-up, the index level was mobile in 83% of the cases (5,3 ° ± 4.1). The mean centre of rotation was in the physiological area in 78% of cases without relevant modification of adjacent disc levels (Spineview® analysis). Conclusion. The 6 years clinical follow-up demonstrate the reliability of the concept and the safety and forgiveness of the implant


The Bone & Joint Journal
Vol. 104-B, Issue 1 | Pages 134 - 141
1 Jan 2022
Cnudde PHJ Nåtman J Hailer NP Rogmark C

Aims

The aim of this study was to investigate the potentially increased risk of dislocation in patients with neurological disease who sustain a femoral neck fracture, as it is unclear whether they should undergo total hip arthroplasty (THA) or hemiarthroplasty (HA). A secondary aim was to investgate whether dual-mobility components confer a reduced risk of dislocation in these patients.

Methods

We undertook a longitudinal cohort study linking the Swedish Hip Arthroplasty Register with the National Patient Register, including patients with a neurological disease presenting with a femoral neck fracture and treated with HA, a conventional THA (cTHA) with femoral head size of ≤ 32 mm, or a dual-mobility component THA (DMC-THA) between 2005 and 2014. The dislocation rate at one- and three-year revision, reoperation, and mortality rates were recorded. Cox multivariate regression models were fitted to calculate adjusted hazard ratios (HRs).


The Journal of Bone & Joint Surgery British Volume
Vol. 84-B, Issue 1 | Pages 19 - 22
1 Jan 2002
Kosygan KP Mohan R Newman RJ

We performed a randomised, prospective trial in 111 patients with intertrochanteric fractures of the hip comparing the use of the Gotfried percutaneous compression plate (PCCP) with that of the classic hip screw (CHS). Blood loss and transfusion requirement were less in the PCCP group but the operating time was significantly longer. The complication rate after operation was similar in both groups, and at a minimum follow-up of six months there was no difference in the rates of fracture healing or implant failure. The PCCP gives results which are similar to those obtained with a conventional device. Its suggested advantages seem to be theoretical rather than practical and, being a fixed-angle implant, it is not universally applicable


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 3 | Pages 393 - 398
1 Mar 2011
Findlay JM Keogh MJ Boulton C Forward DP Moran CG

We performed a retrospective study of a departmental database to assess the efficacy of a new model of orthopaedic care on the outcome of patients with a fracture of the proximal femur. All 1578 patients admitted to a university teaching hospital with a fracture of the proximal femur between December 2007 and December 2009 were included. The allocation of Foundation doctors years 1 and 2 was restructured from individual teams covering several wards to pairs covering individual wards. No alterations were made in the numbers of doctors, their hours, out-of-hours cover, or any other aspect of standard patient care. Outcome measures comprised 30-day mortality and cause, complications and length of stay. Mortality was reduced from 11.7% to 7.6% (p = 0.007, Cox’s regression analysis); adjusted odds ratio was 1.559 (95% confidence interval 1.128 to 2.156). Reductions were seen in Clostridium difficile colitis (p = 0.017), deep wound infection (p = 0.043) and gastrointestinal haemorrhage (p = 0.033). There were no differences in any patient risk factors (except the prevalence of chronic obstructive pulmonary disease), cause of death and length of stay before and after intervention. The underlying mechanisms are unclear, but may include improved efficiency and medical contact time. These findings may have implications for all specialties caring for patients on several wards, and we believe they justify a prospective trial to further assess this effect


The Journal of Bone & Joint Surgery British Volume
Vol. 78-B, Issue 3 | Pages 391 - 394
1 May 1996
Calder SJ Anderson GH Jagger C Harper WM Gregg PJ

We performed a randomised prospective trial to compare a cemented unipolar prosthesis (Thompson) with a cemented bipolar prosthesis (Monk) in the treatment of displaced intracapsular fractures of the hip in patients over 80 years of age. Patients with a mental test score of less than 5/13 were excluded but the mortality was still about 30% at one year in both groups. We therefore feel that subjective criteria such as the level of pain and the return to the preinjury state are of paramount importance. Two years after operation there was no statistical difference between the rate of complications in the two groups. After adjusting for confounding factors such as differences in the level of function before injury between the groups, the degree of return to the preinjury state was significantly greater (p = 0.04) when using the unipolar prosthesis, which is one-quarter of the price of the bipolar. We cannot therefore justify the use of an expensive bipolar prosthesis in patients over 80 years of age


The Journal of Bone & Joint Surgery British Volume
Vol. 80-B, Issue 3 | Pages 485 - 489
1 May 1998
Clatworthy MG Clark DI Gray DH Hardy AE

We performed a randomised, prospective trial to evaluate the use of unreamed titanium nails for femoral fractures. Of 48 patients with 50 femoral fractures 45 were followed to union; 23 with an unreamed and 22 with a reamed nail. The study was stopped early because of a high rate of implant failure. The fractures in the unreamed group were slower to unite (39.4 weeks) than those in the reamed group (28.5 weeks; p = 0.007). The time to union was over nine months in 57% of the unreamed group and in 18% of the reamed group. In the unreamed group 14 secondary procedures were required in ten patients to enhance healing compared with three in three patients in the reamed group. Six implants (13%) failed, three in each group. Four of these six fractures showed evidence of delayed union. To achieve quicker union and fewer implant failures we recommend the use of reamed nails of at least 12 mm in diameter for female patients and 13 mm in males


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 898 - 901
1 May 2021
Axelrod D Trask K Buckley RE Johal H

Aims

This study reviews the past 30 years of research from the Canadian Orthopedic Trauma Society (COTS), to identify predictive factors that delay or accelerate the course of randomized controlled trials in orthopaedic trauma.

Methods

We conducted a methodological review of all papers published through the Canadian Orthopaedic Trauma Society or its affiliates. Data abstracted included: year of publication; journal of publication; study type; number of study sites; sample size; and achievement of sample size goals. Information about the study timelines was also collected, including: the date of study proposal to COTS; date recruitment began; date recruitment ended; and date of publication.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 746 - 754
1 Apr 2021
Schnetzke M El Barbari J Schüler S Swartman B Keil H Vetter S Gruetzner PA Franke J

Aims

Complex joint fractures of the lower extremity are often accompanied by soft-tissue swelling and are associated with prolonged hospitalization and soft-tissue complications. The aim of the study was to evaluate the effect of vascular impulse technology (VIT) on soft-tissue conditioning in comparison with conventional elevation.

Methods

A total of 100 patients were included in this prospective, randomized, controlled monocentre study allocated to the three subgroups of dislocated ankle fracture (n = 40), pilon fracture (n = 20), and intra-articular calcaneal fracture (n = 40). Patients were randomized to the two study groups in a 1:1 ratio. The effectiveness of VIT (intervention) compared with elevation (control) was analyzed separately for the whole study population and for the three subgroups. The primary endpoint was the time from admission until operability (in days).


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1229 - 1241
14 Sep 2020
Blom RP Hayat B Al-Dirini RMA Sierevelt I Kerkhoffs GMMJ Goslings JC Jaarsma RL Doornberg JN

Aims

The primary aim of this study was to address the hypothesis that fracture morphology might be more important than posterior malleolar fragment size in rotational type posterior malleolar ankle fractures (PMAFs). The secondary aim was to identify clinically important predictors of outcome for each respective PMAF-type, to challenge the current dogma that surgical decision-making should be based on fragment size.

Methods

This observational prospective cohort study included 70 patients with operatively treated rotational type PMAFs, respectively: 23 Haraguchi Type I (large posterolateral-oblique), 22 Type II (two-part posterolateral and posteromedial), and 25 (avulsion-) Type III. There was no standardized protocol on how to address the PMAFs and CT-imaging was used to classify fracture morphology and quality of postoperative syndesmotic reduction. Quantitative 3D-CT (Q3DCT) was used to assess the quality of fracture reduction, respectively: the proportion of articular involvement; residual intra-articular: gap, step-off, and 3D-displacement; and residual gap and step-off at the fibular notch. These predictors were correlated with the Foot and Ankle Outcome Score (FAOS) at two-years follow-up.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 55 - 63
1 Jan 2020
Hagberg K Ghassemi Jahani S Kulbacka-Ortiz K Thomsen P Malchau H Reinholdt C

Aims

The aim of this study was to describe implant and patient-reported outcome in patients with a unilateral transfemoral amputation (TFA) treated with a bone-anchored, transcutaneous prosthesis.

Methods

In this cohort study, all patients with a unilateral TFA treated with the Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) implant system in Sahlgrenska University Hospital, Gothenburg, Sweden, between January 1999 and December 2017 were included. The cohort comprised 111 patients (78 male (70%)), with a mean age 45 years (17 to 70). The main reason for amputation was trauma in 75 (68%) and tumours in 23 (21%). Patients answered the Questionnaire for Persons with Transfemoral Amputation (Q-TFA) before treatment and at two, five, seven, ten, and 15 years’ follow-up. A prosthetic activity grade was assigned to each patient at each timepoint. All mechanical complications, defined as fracture, bending, or wear to any part of the implant system resulting in removal or change, were recorded.