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The Bone & Joint Journal
Vol. 97-B, Issue 8 | Pages 1050 - 1055
1 Aug 2015
Drexler M Abolghasemian M Kuzyk PR Dwyer T Kosashvili Y Backstein D Gross AE Safir O

This study reports the clinical outcome of reconstruction of deficient abductor muscles following revision total hip arthroplasty (THA), using a fresh–frozen allograft of the extensor mechanism of the knee. A retrospective analysis was conducted of 11 consecutive patients with a severe limp because of abductor deficiency which was confirmed on MRI scans. The mean age of the patients (three men and eight women) was 66.7 years (52 to 84), with a mean follow-up of 33 months (24 to 41). . Following surgery, two patients had no limp, seven had a mild limp, and two had a persistent severe limp (p = 0.004). The mean power of the abductors improved on the Medical Research Council scale from 2.15 to 3.8 (p < 0.001). Pre-operatively, all patients required a stick or walking frame; post-operatively, four patients were able to walk without an aid. Overall, nine patients had severe or moderate pain pre-operatively; ten patients had no or mild pain post-operatively. . At final review, the Harris hip score was good in five patients, fair in two and poor in four. . We conclude that using an extensor mechanism allograft is relatively effective in the treatment of chronic abductor deficiency of the hip after THA when techniques such as local tissue transfer are not possible. . Longer-term follow-up is necessary before the technique can be broadly applied. Cite this article: Bone Joint J 2015;97-B:1050–5


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXV | Pages 8 - 8
1 Jun 2012
Baldini A Manfredini L Mariani PC Barbanti B
Full Access

Extensor mechanism disruption in total knee arthroplasty (TKA) occurs infrequently but often requires surgical intervention. We compared two cohorts undergoing extensor mechanism allograft reconstruction, one group had an extensor mechanism rupture, and the other had a recurrent ankylosed knee. Thirteen consecutive patients with extensor mechanism disruption or ankylosis after TKA were treated. Two different types of extensor mechanism allografts were used: quadriceps tendon-patella-patella tendon-tibial tubercle, and Achilles tendon allograft(Fig1). Demographic factors, diagnosis at extensor failure, Knee Society clinical rating scores, radiographs, and patient satisfaction were recorded. The average time from extensor mechanism disruption to surgery was 6.6 months (range, 1-24 months). At a mean followup of 24 months (range, 6-46 months), all patients were community ambulators. None of the patients showed a postoperative extensor lag. Average postoperative maximum flexion was 97° (90-115°) for the ruptured group and 80° (75-90) for the ankylosed grup. All patients thought their functional status had improved, and 87% were satisfied with the results of the allograft reconstruction (Fig 2, 3, 4, 5). One patient had allograft failure due to recurrent infection after re-revision for sepsis. The total extensor mechanism allograft and Achilles tendon allograft both were successful in the treatment of the failed extensor mechanism and showed promising results for the treatment of the ankylosed knee


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 7 | Pages 986 - 990
1 Sep 2004
Burnett RSJ Fornasier VL Haydon CM Wehrli BM Whitewood CN Bourne RB

We present the histological findings of an extensor mechanism allograft which was used in a total knee arthroplasty two years after implantation. Analysis of the graft was undertaken at four distinct anatomical levels and it was found to be incorporated into host tissue at each level. A wedge of fibrinoid necrosis, probably related to impingement of the graft on the tibial polyethylene insert, was seen. Impingement may play a role in the injury and necrosis of an allograft and may be one mode of failure in an extensor mechanism allograft


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 407 - 407
1 Nov 2011
Finch J Morawa L Ramakrishnan R
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In patients with significant bone loss and a nonfunctioning extensor mechanism, the approach to revision is complicated. We describe a unique approach to solve this complex problem to help restore clinically satisfactory results. Our technique involves the use of a donor allograft that consists of proximal tibia along with the attached extensor mechanism (patellar tendon-patella-quadriceps tendon). Five reconstructions utilizing bone allografts and extensor mechanisms were performed by two surgeons. Each has extensive surgical history on the affected knee and presented with gross instability, considerable bone loss, and significant extensor lag or total loss of extension. The implants used were press-fit stems with the tibial baseplate cemented into the allograft prior to implantation. In this series, either hinged or total stabilized prostheses were used. The follow up ranged from 1 to 5 years. The only complication to date was reported in one patient who required irrigation and debridement with surgical wound closure after partial dehiscence. However the patency of the allograft was not disrupted. All prostheses have been noted to be stable with no signs of loosening. This procedure presented should be considered a salvage procedure for bone stock and extensor mechanism deficiency in revision total knee arthroplasty. The advantage to our allograft is the inherent stability of the proximal tibia with the tibial tubercle and associated extensor mechanism. For patients with this complex deficiency, there has been no effective method of treatment and we advocate the use of this procedure to restore function and relieve pain to an otherwise grossly unstable and functionally limited joint


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1078 - 1085
1 Oct 2023
Cance N Batailler C Shatrov J Canetti R Servien E Lustig S

Aims. Tibial tubercle osteotomy (TTO) facilitates surgical exposure and protects the extensor mechanism during revision total knee arthroplasty (rTKA). The purpose of this study was to determine the rates of bony union, complications, and reoperations following TTO during rTKA, to assess the functional outcomes of rTKA with TTO at two years’ minimum follow-up, and to identify the risk factors of failure. Methods. Between January 2010 and September 2020, 695 rTKAs were performed and data were entered into a prospective database. Inclusion criteria were rTKAs with concomitant TTO, without extensor mechanism allograft, and a minimum of two years’ follow-up. A total of 135 rTKAs were included, with a mean age of 65 years (SD 9.0) and a mean BMI of 29.8 kg/m. 2. (SD 5.7). The most frequent indications for revision were infection (50%; 68/135), aseptic loosening (25%; 34/135), and stiffness (13%; 18/135). Patients had standardized follow-up at six weeks, three months, six months, and annually thereafter. Complications and revisions were evaluated at the last follow-up. Functional outcomes were assessed using the Knee Society Score (KSS) and range of motion. Results. The mean follow-up was 51 months (SD 26; 24 to 121). Bony union was confirmed in 95% of patients (128/135) at a mean of 3.4 months (SD 2.7). The complication rate was 15% (20/135), consisting of nine tibial tubercle fracture displacements (6.7%), seven nonunions (5%), two delayed unions, one tibial fracture, and one wound dehiscence. Seven patients (5%) required eight revision procedures (6%): three bone grafts, three osteosyntheses, one extensor mechanism allograft, and one wound revision. The functional scores and flexion were significantly improved after surgery: mean KSS knee, 48.8 (SD 17) vs 79.6 (SD 20; p < 0.001); mean KSS function, 37.6 (SD 21) vs 70.2 (SD 30; p < 0.001); mean flexion, 81.5° (SD 33°) vs 93° (SD 29°; p = 0.004). Overall, 98% of patients (n = 132) had no extension deficit. The use of hinge implants was a significant risk factor for tibial tubercle fracture (p = 0.011). Conclusion. TTO during rTKA was an efficient procedure to improve knee exposure with a high union rate, but had significant specific complications. Functional outcomes were improved at mid term. Cite this article: Bone Joint J 2023;105-B(10):1078–1085


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_I | Pages 99 - 99
1 Mar 2006
Ribas M Vilarrubias J Silberberg J Leal J Ginebreda I
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Introduction: knee revision in absence of Extensor Mechanism has been always a challenging problem in Orthopaedics. Many authors are in favour to abandone any endoprosthetic substitution in front of such a situation. We think osteotendinous allografts, in this particular case whole Extensor Mechanism allografts, could play an essential role before any Knee Arthrodesis. Material and Method: From 1999 up to 2004 11 patients (4 male, 7 female) (mean age 72, range 68 to 86) underwent to a whole Extensor Mechanism allografting procedure. Mean follow up was 2.7 years (1 to 5 years). In the first four cases a whole Extensor Mechanism allograft was implanted, while the next seven cases the allograft was reinforced by means of a Leeds-Keio Dacron band. Results: There was no infections in this serie. The mean obtained R.O.M. in the first three months was – 5 of active extension (range 0 to −15) and 95 active flexion (range 80 – 110). However 3 from the 4 former operated cases had a progressive loss of active extension up to −25 (range −20 to −35) at 18 months, that did not increase after this period. Ultrasonic exams showed a lengthening of the patellar tendon in these cases. None of these 3 patients wished to undergo to a patellar tendon reinforcement. On the other hand those later cases, where patellar tendon was reinforced did not show any change over the time (at 18 months mean active extension was maintained to −5 (range 0 to 15). Conclusions: Extensor mechanism allografts are very useful in difficult knee revisions with absence of extensor mechanism, so that knee arthrodesis is not the method of choice for these patients. However augmentation of patellar tendon is necessary to maintain with the years an active extension


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 95 - 95
1 May 2014
Windsor R
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A key component to the success of total knee replacement is the health and integrity of the extensor mechanism. While there are issues related to the patella, such as fracture, dislocation, subluxation, clunk due to peripatellar fibrosis and anterior knee pain, the overall integrity of the extensor mechanism is of tantamount importance in providing an excellent functional outcome. During total knee replacement it is of utmost importance to preserve the anatomic insertion of the patellar tendon on the tibial tubercle. However, after total knee replacement, a fall or extreme osteoporosis of the patella may cause a rupture of the patellar tendon, distally or proximally, and possibly the quadriceps tendon off of the proximal pole of the patella. Simple repairs of the patellar tendon avulsion may involve use of the semitendonosis and gracilis tendons along with primary repair of the tendon. Usually, patella infera develops after such a repair affecting overall strength and function. For severe disruptions of the extensor mechanism that are accompanied by a significant extensor lag, autologous tissue repair may not be possible. Thus, there are three techniques for reconstruction of this difficult problem: Extensor mechanism allograft with bone-patellar tendon-patella-quadriceps tendon, extensor mechanism allograft with os calcis-Achilles tendon construct and Marlex-mesh reconstruction for patellar tendon avulsion. The key to success of extensor mechanism allograft is proper tensioning of the allograft at full extensor and immobilisation for 6 weeks. Rosenberg's early experience showed that the allograft works best placed at maximum tension in extension. Rubash has described the use of the os calcis-Achilles tendon which does not utilise a patellar substitute. Hansen has recently described excellent results with the use of Marlex mesh to act as a structural reinforcement to the patellar tendon when it is avulsed


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_22 | Pages 97 - 97
1 May 2013
Windsor R
Full Access

A key component to the success of total knee replacement is the health and integrity of the extensor mechanism. While there are issues related to the patella, such as fracture, dislocation, subluxation, clunk due to peripatellar fibrosis and anterior knee pain, the overall integrity of the extensor mechanism is of tantamount importance in providing an excellent functional outcome. During total knee replacement it is of utmost importance to preserve the anatomic insertion of the patellar tendon on the tibial tubercle. However, after total knee replacement, a fall or extreme osteoporosis of the patella may cause a rupture of the patellar tendon, distally or proximally, and possibly the quadriceps tendon off of the proximal pole of the patella. Simple repairs of the patellar tendon avulsion may involve use of the semitendonosis and gracilis tendons along with primary repair of the tendon. Usually, patella infera develops after such a repair affecting overall strength and function. For severe disruptions of the extensor mechanism that are accompanied by a significant extensor lag, autologous tissue repair may not be possible. Thus, there are three techniques for reconstruction of this difficult problem: Extensor mechanism allograft with bone-patellar tendon-patella-quadriceps tendon, extensor mechanism allograft with os calcis-Achilles tendon construct and Marlex-mesh reconstruction for patellar tendon avulsion. The key to success of extensor mechanism allograft is proper tensioning of the allograft at full extensor and immobilisation for 6 weeks. Rosenberg's early experience showed that the allograft works best placed at maximum tension in extension. Rubash has described the use of the os calsis-Achilles tendon which does not utilise a patellar substitute. Hansen has recently described excellent results with the use of Marlex mesh to act as a structural reinforcement to the patellar tendon when it is avulsed


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_7 | Pages 101 - 101
1 Apr 2017
Engh C
Full Access

Extensor mechanism complications after or during total knee arthroplasty are problematic. The prevalence ranges from 1–12% in TKR patients. Treatment results for these problems are inferior to the results of similar problems in non-TKR patients. Furthermore, the treatment algorithm is fundamentally different from that of non-TKR patients. The surgeon's first question does not focus on primary fixation; rather the surgeon must ask if the patient needs surgery and if so am I prepared to augment the repair? Quadriceps tendon rupture, periprosthetic patellar fracture, and patellar tendon rupture have similar treatment algorithms. Patients who are able to perform a straight leg raise and have less than a 20-degree extensor lag are generally treated non-operatively with extension bracing. The remaining patients will need surgical reconstruction of the extensor mechanism. Loose patellar components are removed. Primary repair alone is associated with poor results. Whole extensor mechanism allograft, Achilles tendon allograft, and synthetic mesh reconstruction are the current techniques for augmentation. In the acute setting if these are not available hamstring tendon harvest and augmentation is an option. Achilles tendons and synthetic mesh are easier to obtain than and entire extensor mechanism but are limited to patients that have an intact patella and the patella that can be mobilised to within 2–3 cm of the joint line. No matter which technique is used the principles are: rigid distal/tubercle fixation, coverage of allograft/mesh with host tissue to decrease infection, tensioning the augment material in extension, no flexion testing of reconstruction and post-operative extension bracing


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_17 | Pages 66 - 66
1 Nov 2016
Engh C
Full Access

Extensor mechanism complications after or during total knee arthroplasty (TKA) are problematic. The prevalence ranges from 1%-12% in TKA patients. Treatment results for these problems are inferior to the results of similar problems in non-TKA patients. Furthermore, the treatment algorithm is fundamentally different from that of non-TKA patients. The surgeon's first question does not focus on primary fixation; rather the surgeon must ask if the patient needs surgery and if so am I prepared to augment the repair? Quadriceps tendon rupture, peri-prosthetic patellar fracture, and patellar tendon rupture have similar treatment algorithms. Patients who are able to perform a straight leg raise and have less than a 20-degree extensor lag are generally treated non-operatively with extension bracing. The remaining patients will need surgical reconstruction of the extensor mechanism. Loose patellar components are removed. Primary repair alone is associated with poor results. Whole extensor mechanism allograft, Achilles tendon allograft, and synthetic mesh reconstruction are the current techniques for augmentation. In the acute setting if these are not available, hamstring tendon harvest and augmentation is an option. Achilles tendons and synthetic mesh are easier to obtain than an entire extensor mechanism but are limited to patients that have an intact patella and the patella that can be mobilised to within 2–3 cm of the joint line. No matter which technique is used the principles are: rigid distal/tubercle fixation, coverage of allograft/mesh with host tissue to decrease infection, tensioning the augment material in extension, no flexion testing of reconstruction and post-operative extension bracing


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 11_Supple_A | Pages 116 - 119
1 Nov 2012
Rosenberg AG

Disruption of the extensor mechanism in total knee arthroplasty may occur by tubercle avulsion, patellar or quadriceps tendon rupture, or patella fracture, and whether occurring intra-operatively or post-operatively can be difficult to manage and is associated with a significant rate of failure and associated complications. This surgery is frequently performed in compromised tissues, and repairs must frequently be protected with cerclage wiring and/or augmentation with local tendon (semi-tendinosis, gracilis) which may also be used to treat soft-tissue loss in the face of chronic disruption. Quadriceps rupture may be treated with conservative therapy if the patient retains active extension. Component loosening or loss of active extension of 20° or greater are clear indications for surgical treatment of patellar fracture. Acute patellar tendon disruption may be treated by primary repair. Chronic extensor failure is often complicated by tissue loss and retraction can be treated with medial gastrocnemius flaps, achilles tendon allografts, and complete extensor mechanism allografts. Attention to fixing the graft in full extension is mandatory to prevent severe extensor lag as the graft stretches out over time


Orthopaedic Proceedings
Vol. 93-B, Issue SUPP_IV | Pages 418 - 419
1 Nov 2011
Long W Scuderi G
Full Access

Bone loss is a challenging reconstructive problem in revision total knee arthroplasty (TKA). Uncemented porous tantalum modular components are designed to act as substitutes for allograft bone in complex revision TKA with significant bone defects. A consecutive series of 23 revision TKAs performed by a single surgeon were reviewed at a minimum two-years following implantation. In all cases bone loss was assessed using the Anderson Orthopaedic Research Institute System, and porous tantalum components were used to augment the reconstructions when bone loss was encountered. Twenty-one patients had 23 procedures (2 bilateral) requiring the use of porous tantalum following 18 cases of aseptic loosening, 4 cases of staged re-implantation for infection, and 1 case of a periprosthetic patellar fracture and aseptic loosening. Structural bone graft was not used during this time period. Porous tantalum uses include: 20 distal and posterior femoral augments; 2 femoral cones; 8 patellar augments; and 18 tibial cones. 20 cases required augmentation in more than one area, and one case involved an extensor mechanism allograft. There were 2 cases of recurrent sepsis requiring removal of well-fixed tantalum components. At an average 37 months (24 to 73) no patients were lost to follow-up. Clinical follow-up in the remaining 21 cases showed reconstructions were functioning well with no revisions. Radiographic imaging showed re-establishment of the joint line, neutral mechanical axis, and signs of stable fixation of the augments. There were no cases of radiographic or clinical loosening at the most recent follow-up. Short term results with the use of porous tantalum augments and cones for bone loss in revision TKA demonstrate the versatile, and durable nature of these new reconstructive tools, at early follow-up


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_12 | Pages 67 - 67
1 Jul 2014
Haidukewych G
Full Access

Despite our best efforts, occasionally, certain patients will have multiply operated, failed reconstructions after TKA. There are situations where further attempts at arthroplasty are unwise, for example, chronic infections with multiple failed staged reconstructions. A careful pre-operative evaluation of the patient is critical to guide decision-making. An assessment of medical comorbidity, functional demands, and expectations is important. Regarding the extremity, the severity of bone loss, soft tissue defects, ligamentous competency, and neurovascular status is important. The next step is to determine whether the knee is infected. The details of such a workup are covered in other lectures, however, the author prefers to aspirate all such knees and obtain C reactive protein and sedimentation rates. For equivocal cases, PCR may be helpful. If no infection is present, complex reconstruction is considered. Segmental megaprosthesis and hinged prostheses may be helpful. Often, soft tissue reconstruction with an extensor mechanism allograft or muscle flap is required. Obviously, these are massive undertakings and should be done by experienced surgeons. If a prosthesis is not a good option, other options include definitive resection, knee arthrodesis, or above knee amputation. A careful discussion with the patient about the pros and cons is necessary to allow them to partner with the surgeon in the decision-making. Definitive resections are reserved for minimal to non-ambulators with significant comorbidity that do not desire an AKA. AKA is often the best option, however, it should be noted that the majority of these patients will never ambulate with a prosthesis due to the energy requirements necessary to do so. High complication rates and reoperation rates have been reported with AKA after TKA. Functional outcome studies have generally shown better function with arthrodesis than with AKA. Arthrodesis can be effective and can be accomplished with several methods. If active infection is present, an external fixator is typically chosen. If no infection is present then plating or long intramedullary nailing is considered. Plating requires healthy anterior soft tissues due to the bulk associated with double plating techniques. The highest union rates have been reported with long nails. The author therefore prefers to use long nails after eradicating infection with a staged procedure (interval spacer) rather than to use an external fixator. Union rates are higher with nails, but the risk of re-infection is slightly higher as well. Careful attention to detail is necessary to minimise complications


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_8 | Pages 109 - 109
1 May 2014
Haidukewych G
Full Access

Despite our best efforts, occasionally, certain patients will have multiply operated, failed reconstructions after TKA. There are situations where further attempts at arthroplasty are unwise, for example, chronic infections with multiple failed staged reconstructions. A careful preoperative evaluation of the patient is critical to guide decision-making. An assessment of medical comorbidity, functional demands, and expectations is important. Regarding the extremity, the severity of bone loss, soft tissue defects, ligamentous competency, and neurovascular status is important. The next step is to determine whether the knee is infected. The details of such a workup are covered in other lectures, however, the author prefers to aspirate all such knees and obtain C reactive protein and Sedimentation Rates. For equivocal cases, PCR may be helpful. If no infection is present, complex reconstruction is considered. Segmental megaprosthesis and hinged prostheses may be helpful. Often, soft tissue reconstruction with an extensor mechanism allograft or muscle flap is required. Obviously, these are massive undertakings and should be done by experienced surgeons. If a prosthesis is not a good option, other options include definitive resection, knee arthrodesis, or above knee amputation. A careful discussion with the patient about the pros and cons is necessary to allow them to partner with the surgeon in the decision-making. Definitive resections are reserved for minimal to non-ambulators with significant co-morbidity that do not desire an AKA. AKA is often the best option, however, it should be noted that the majority of these patients will never ambulate with a prosthesis due to the energy requirements necessary to do so. High complication rates and reoperation rates have been reported with AKA after TKA. Functional outcome studies have generally shown better function with arthrodesis than with AKA. Arthrodesis can be effective and can be accomplished with several methods. If active infection is present, and external fixator is typically chosen. If no infection is present then plating or long intramedullary nailing is considered. Plating requires healthy anterior soft tissues due the bulk associated with double plating techniques. The highest union rates have been reported with long nails. The author therefore prefers to use long nails after eradicating infection with a staged procedure (interval spacer) rather than to use an external fixator. Union rates are higher with nails, but the risk of re-infection is slightly higher as well. Careful attention to detail is necessary to minimise complications


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 468 - 474
1 May 2024
d'Amato M Flevas DA Salari P Bornes TD Brenneis M Boettner F Sculco PK Baldini A

Aims

Obtaining solid implant fixation is crucial in revision total knee arthroplasty (rTKA) to avoid aseptic loosening, a major reason for re-revision. This study aims to validate a novel grading system that quantifies implant fixation across three anatomical zones (epiphysis, metaphysis, diaphysis).

Methods

Based on pre-, intra-, and postoperative assessments, the novel grading system allocates a quantitative score (0, 0.5, or 1 point) for the quality of fixation achieved in each anatomical zone. The criteria used by the algorithm to assign the score include the bone quality, the size of the bone defect, and the type of fixation used. A consecutive cohort of 245 patients undergoing rTKA from 2012 to 2018 were evaluated using the current novel scoring system and followed prospectively. In addition, 100 first-time revision cases were assessed radiologically from the original cohort and graded by three observers to evaluate the intra- and inter-rater reliability of the novel radiological grading system.


The Bone & Joint Journal
Vol. 101-B, Issue 6_Supple_B | Pages 116 - 122
1 Jun 2019
Whiteside LA Roy ME

Aims

The aims of this study were to assess the exposure and preservation of the abductor mechanism during primary total hip arthroplasty (THA) using the posterior approach, and to evaluate gluteus maximus transfer to restore abductor function of chronically avulsed gluteus medius and minimus.

Patients and Methods

A total of 519 patients (525 hips) underwent primary THA using the posterior approach, between 2009 and 2013. The patients were reviewed preoperatively and at two and five years postoperatively. Three patients had mild acute laceration of the gluteus medius caused by retraction. A total of 54 patients had mild chronic damage to the tendon (not caused by exposure), which was repaired with sutures through drill holes in the greater trochanter. A total of 41 patients had severe damage with major avulsion of the gluteus medius and minimus muscles, which was repaired with sutures through bone and a gluteus maximus flap transfer to the greater trochanter.


Bone & Joint 360
Vol. 6, Issue 2 | Pages 14 - 17
1 Apr 2017


The Bone & Joint Journal
Vol. 96-B, Issue 11_Supple_A | Pages 122 - 124
1 Nov 2014
Haidukewych GJ Petrie JR Adigweme O

Although the vast majority of patients that undergo total knee replacement have satisfactory outcomes with a generally low complication rate, occasionally a patient will be encountered that has had multiple failed surgeries, and now reaches a crossroad as to whether limb salvage will be acceptable or not.

Cite this article: Bone Joint J 2014;96-B(11 Suppl A):122–4.