 KNEE

Metal metaphyseal sleeves in revision total knee replacement

S. Agarwal, A. Azam, R. Morgan-Jones From Cardiff and Vale University Health Board, Cardiff, United Kingdom

Bone loss in the proximal tibia and distal femur is frequently encountered in revision knee replacement surgery. The various options for dealing with this depend on the extent of any bone loss. We present our results with the use of cementless metaphyseal metal sleeves in 103 patients (104 knees) with a mean follow-up of 43 months (30 to 65). At final follow-up, sleeves in 102 knees had good osseointegration. Two tibial sleeves were revised for loosening, possibly due to infection. The average pre-operative Oxford Knee Score was 23 (11 to 36) and this improved to 32 (15 to 46) post-operatively. These early results encourage us to continue with the technique and monitor the outcomes in the long term. Cite this article: Bone Joint J 2013;95-B:1640–4.

©2013 The British Editorial Society of Bone & Joint Surgery doi:10.1302/0301-620X.95B12. 31190 $2.00

The ninth annual report of the National Joint Registry (NJR) for England and Wales found that knee revisions comprised 6.1% of all total knee replacements (TKR) operations in 2011.1 While the number of primary TKRs has been steadily increasing, the increase in revision TKR has also been consistent over the years.1,2 In revision TKR, the surgeon often has to deal with bone loss that may compromise the fixation of the new components. There are various options for managing the bone loss and the surgeon’s choice is dependent on the size and site of any defects. Small, contained defects can be filled with bone graft3,4 or cement,5 while larger defects require bone grafting,6,7 the use of metal augment blocks in association with revision implants,8 the use of a revision component with extended stems,9,10 Tantalum cones,11 or even customised revision prostheses.12 We have addressed metaphyseal defects at revision using partial porous-coated metal metaphyseal-filling sleeves (DePuy, Warsaw, Indiana) to improve the management of bone loss by facilitating stable cementless metaphyseal fixation (Fig. 1). The sleeves can be applied on the femoral or the tibial component. Femoral sleeves are made of titanium and tibial sleeves are made of titanium alloy. The porosity of sleeves is between 50 to 80%. We present our early results of revision TKR using these devices in association with standard tibial and femoral TKR components.

Bone Joint J 2013;95-B:1640–4. Received 30 October 2012; Accepted after revision 20 August 2013

Patients and Methods We retrospectively reviewed the case notes and radiographs of 103 patients (104 knees) who

 S. Agarwal, FRCS Orth, Consultant Orthopaedic Surgeon  A. Azam, MRCS, Specialist Registrar University Hospital of Wales, Heath Park, Cardiff CF14 4XW, UK.  R. Morgan-Jones, FRCS Orth, Consultant Orthopaedic Surgeon University Hospital Llandough, Penlan Road, Llandough CF64 2XX, UK. Correspondence should be sent to Mr S. Agarwal; e-mail: [email protected]

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underwent revision TKR between January 2007 and December 2009 in our centre, with approval of our local audit department. The study group included 54 male and 49 female patients with a mean age of 69 years (48 to 92). The mean follow-up was 43 months (30 to 65). From the notes we obtained available Oxford knee scores (OKS)13 and the pre-operative ranges of movement (ROM). The OKS ranges from 48 (best score) to 0 (worst score). The indications for revision included infection (31 knees), aseptic loosening (43), instability (12), undiagnosed pain (seven) and stiffness (ten). In one patient (one knee), a failed unicompartmental knee replacement was converted to a TKR. In total 89 knees were revised as a single stage operation and in 15 the sleeves were used at the second stage of a two-part procedure. The mean time to revision surgery following the previous joint replacement was 5.7 years (0.5 to 20) in 92 knees. The date of primary operation was not known for 12 knees. Of 104 revision TKRs, 84 were first time revisions and 15 knees had been revised once before, two knees had undergone two prior revisions and three had three or more revisions prior to our revision TKR using the metaphyseal sleeve. The bone loss on pre-operative radiographs was assessed jointly by two authors (SA and AA) on the basis of the Anderson Orthopaedic Research Institute (AORI) classification14 (Table I). CT scans were also used where necessary to assess bone loss around femoral components when it could not be adequately THE BONE & JOINT JOURNAL

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Fig. 1 Photograph showing a metaphyseal sleeve used with tibial component in revision knee replacement (DePuy, Warsaw, Indiana).

Table I. Anderson Orthopaedic Research Institute (AORI) classification of bone defects encountered in revision total knee replacement. Type of bone defect Type I

Type IIA Type IIB

Type III

Treatment options

Minor osseous deficiencies with intact cortical rim, near normal joint line, no component subsidence

Removing bone defect with thicker bone resection, shifting component away from the defect, filling the defect with particulate bone graft or cement and screws More extensive defects with involvement of one condyle In addition to interventions for type I defects, these may of the femur (Type F2A) or tibia (Type T2A) require structural bone graft, prosthetic augments, or metInvolvement of both condyles of femur (F2B) or tibia (T2B). aphyseal sleeves or cones to restore joint line The cortical rim may be intact or deficient, and is associated with some loss of central and peripheral metaphyseal bone. Implant subsidence may be present, but collateral ligaments are preserved Extensive loss of metaphyseal bone, collateral ligaments Constrained prosthesis are often required, along with may be compromised structural allograft, metaphyseal sleeves or cones, condyle replacing hinged replacements, or amputation

assessed on the plain radiographs. A further review of bone loss was made at the time of revision surgery after the removal of components. The final assessment at the time of surgery was used to grade the degree of bone loss. Based on final assessment, on the femoral side, two knees had Grade I bone loss, six had Grade IIA bone loss, 46 knees showed Grade IIB bone loss and two had Grade III bone loss. The remaining 48 knees had no significant femoral bone loss. On the tibial side, Grade IIA bone loss was identified in 27 knees, Grade IIB in 39 knees and Grade III in 11 knees with 27 having no loss. The mean pre-operative and postoperative Oxford Knee scores were compared using the related sample Wilcoxon signed rank test for non parametric data. The software used was SPSS 20.0 (IBM Inc). Surgical technique. Adequate exposure is achieved through a medial parapatellar arthrotomy and a tibial tubercle VOL. 95-B, No. 12, DECEMBER 2013

osteotomy was used to improve exposure, if needed. Quadriceps snip was used in 23 patients and a tibial tubercle osteotomy in 48 patients. Existing components were removed using flexible osteotomes to minimise additional bone loss. The polyethylene insert was removed first, followed by the femoral component and then the tibial component. In patients with infection, a thorough debridement was done, with removal of the membrane and all cement. In non infected revisions, well fixed cement was retained except where it would interfere with osseointegration of the metaphyseal sleeve. We first prepare the tibial or femoral medullary canal to accept a prosthetic stem. Hand held reamers are used with progressive increase in size, until cortical contact is obtained in the diaphysis at the desired stem length. Once the desired stem size is obtained, the proximal tibia is

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prepared with the broach to accept the sleeve. The broach is inserted with a stem trial attached to the end of the broach, and this helps to keep the broach central in the bone. For ease of broaching, we undersize the stem trial by one size and this allows broaching without the stem trial being too tight in the diaphysis. On the femoral side, the bone preparation is similar. Infected membrane is removed as is all cement in infected revisions. The femoral canal is prepared with hand held broaches to accept the desired stem size. The sleeve attaches to the box section of the femoral component and a stem is attached to the proximal end of the sleeve. This is in contrast to the tibia, where the sleeve is attached to the tibial component independently of the stem. The tibial sleeves are available in five sizes and the femoral sleeves in four sizes. The correct size sleeve should fill the metaphyseal bone defect and achieve contact with the cancellous bone. Tibial height can be adjusted with this system, as a bigger sleeve will facilitate more proximal positioning of the tibial tray. Similarly, on the femur, a larger sleeve will allow more distal placement of the femoral component. This allows restoration of joint line where the components had migrated proximally with bone loss. The final tibial tray seating is carried out with an oscillating saw using the proximal surface of the broach as a reference. Metal augmentation on the undersurface of the tibial tray cannot be used along with these sleeves. Once the correct size sleeve and stem is determined, a trial reduction is carried out. This is done with the trial components assembled. The flexion and extension gaps are checked with the femoral component in situ, and are matched accurately. Soft-tissue releases can be done as required for medial/lateral tightness. The tibial and femoral components can be positioned at the desired level with the use of metaphyseal sleeves to restore the joint line. Once the balancing has been achieved, the component is assembled on the table making sure the rotational orientation of the sleeve on the implant matches the rotation of the sleeve on the trial. Cement is confined to the proximal surface of the tibia and not on the stem or sleeve. The upper part of the sleeve is porous-coated and we do not cement the stems as the purpose of stem is predominantly to centralise the component rather than bear load. The size of sleeve used depends on the amount of bone loss and the size can be altered to position the femoral component more distally or proximally as required for gap balancing. Both distal and posterior metal femoral augments can be used alongside femoral sleeves in order to deal with condylar bone loss. Alternatively, smaller defects on the condyles can be filled with cement or bone graft. As with the tibia we use narrow stems for alignment and not to bear load. Femoral metaphyseal sleeves alone were used in three knees and 41 had only tibial metaphyseal sleeves implanted. Both tibial and femoral metaphyseal sleeves were used in 60 knees. An intramedullary stem was used on the femoral side in one knee, on the tibial side in 20 knees

and on both tibial and femoral side in 78 knees. In five knees, stems were not used on either side. In terms of TKRs 53 knees had a Total Condylar III (TC3) femoral component (DePuy, Warsaw, Indiana) with a mobile bearing tibial ultra-high-density polyethylene tray (MBT) implanted. A further 45 had a Press Fit Condylar (PFC, DePuy) posterior stabilised femoral components with MBT tibial trays. In four knees a PFC cruciate retaining TKR with a MBT tibial tray was used and two knees had a TC3 femur with fixed bearing tibial component. The tibial metaphyseal sleeves cannot be attached to fixed bearing tibial trays in this system as these are not compatible with fixed bearing tibial components. The two patients with fixed bearing tibial components had sleeves on the femoral side only. Post-operative management. Post-operative assessment was carried out at six to eight weeks and then at one year, and annually thereafter with radiographs obtained at each visit. Osseointegration of the sleeve was assessed on conventional radiographs (AA), and was defined as an absence of radiolucency between the sleeve and the cancellous bone. On the tibial side, four interfaces were defined – the anterior and posterior interface seen on the lateral view and the medial and lateral interface seen in the anteroposterior (AP) view. Of these four, good bone apposition against the sleeve in three views, with absence of radiolucency was defined as representing osseointegration. Progressive radiolucency on serial radiographs was considered as a sign of loosening. Only the proximal third of the metaphyseal sleeve in tibia is porous coated, and this was the part of sleeve used for assessment of osseointegration. On the femoral side, the distal third of the sleeve is porous coated. This is obscured in the AP projection so that only the lateral view was suitable for determining osseointegration of the femoral sleeve.

Results No patient died in the study cohort and no patient was lost to follow-up. At the time of final follow-up the sleeves showed good osseointegration in 102 knees with no evidence of loosening or migration (Fig. 2). At mean follow-up of 43 months (30 to 65), there had been two revisions. No clinical problem was attributable to the use of sleeves in any patient. No patient had implant stem tip pain on either the femoral or tibial sides. 48 patients had a tibial tubercle osteotomy as part of exposure. The osteotomy was not related to clinical outcome. The post-operative rehabilitation was similar to patients without osteotomy. Pre-operative clinical scoring data was available for 89 knees, while post-operative data were available for all patients. Only patients with both pre-operative and post-operative scores were included in the statistical analysis. The mean pre-operative OKS was 23 (SD 7.3; 11 to 36) which improved to 32 (SD 6.7; 15 to 46) post-operatively at last follow-up. On the Wilcoxon signed rank test, the difference in mean OKS was 9.8 (standard deviation 6.6) and 95% confidence interval of the difference from 8.4 to 11.2. The difference between the two groups was significant (p < 0.001). THE BONE & JOINT JOURNAL

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Fig. 2a

Fig. 2b

Fig. 3a

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Fig. 3b

Anteroposterior (a) and lateral (b) radiographs at 36 months showing well-fixed cementless sleeves used at revision total knee replacement.

Anteroposterior (a) and lateral (b) radiographs at six months showing a loose cementless sleeve used at revision total knee replacement.

Pre-operatively 36 patients had a mean fixed flexion deformity of 12° (5° to 20°). Of these 36 patients, 21 achieved full extension following revision surgery, while 15 patients had a residual post-operative fixed flexion deformity of 5° to 8°. Mean flexion improved from 79° (55° to 110°) to 96° (70° to 120°) following the operation. In the two knees which were revised, a progressive radiolucency (Fig. 3) was noted around the metaphyseal sleeve, six months after the revision procedure. Both these patients were symptomatic with dull, continuous pain. One of these patients had a PFC cruciate retaining TKR with a MBT tibial insert and a tibial sleeve. The other patient had PFC posterior stabilised TKR with a MBT tibial insert and a sleeve was used on both femoral and tibial sides. Neither of these two patients had a stem on either femoral or tibial side. These patients were investigated and both were found to have elevated inflammatory markers (CRP 75 and 93, ESR 45 and 39 respectively). The Tc-99 bone scan showed increased uptake in the delayed phase in both these patients in the region of the tibial sleeve. Loosening of the sleeve was confirmed on CT scans. One of these patients had a SPECT scan which raised further suspicion of focal infection around the sleeve. Both these patients had revision surgery on the assumption of infection. The sleeves were confirmed to be loose and were revised to a larger size sleeve along with stems. Microbiology samples taken intra-operatively did not yield positive cultures in either case but both patients had received preoperative antibiotics. Both these patients are now over 24 months following revision of the sleeves and no further problems have been encountered.

principally used with hinged TKRs.15 Using the sleeve is now possible with less constrained prostheses, and the surgeon is able to make use of cementless fixation of the sleeves to host bone to overcome extensive metaphyseal defects. Cement alone is only suitable for smaller defects (AORI type1 and smaller type-2 (< 5 mm) defects).12 Engh and Ammeen16 recommend the use of structural allograft for the management of severe tibial bone loss. At a mean of 95 months (61 to 191) follow-up they did not observe any graft collapse or aseptic loosening associated with the structural allograft. Dennis17 has also described the successful use of structural allograft in 30 patients with good to excellent results in 86% patients at a mean follow-up period of 50 months. One patient had femoral component loosening and another had nonunion of femoral allograft. Another paper 18 reviewed 30 knees with AORI type 3 bone defects who were revised using femoral head allografts. At a mean follow up of 76 months (38 to 136), there were no complications of nonunion, infection, collapse or loosening of components, and no revision surgery was needed. The mean time to healing of the graft was 6.6 months (four to 16). Other studies have raised concerns regarding the availability of appropriate size allografts, disease transmission, late resorption and fracture or non-union of structural allograft.19 Contraindications to the use of allograft include chronic infection, neuropathic arthropathy, metabolic bone disorders, severe immunosuppression and local radiation necrosis.16 Brand et al20 advocated that metal augments fitted to tibial and femoral components are a mechanically sound option. The advantage of a metal augment is their ready availability and ease of application. Wedged augments inevitably create shear stresses 21 and have to be combined with stems to offset loading. Hockman, Ammeen and Engh22 found that modular augmentation devices could not adequately address the bone loss effectively in 48% of cases.

Discussion Metaphyseal sleeves are not a new concept in the field of revision knee surgery but until recently they were VOL. 95-B, No. 12, DECEMBER 2013

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Pour et al23 described the use of rotating hinge implants in revision for extensive bone loss but also cautioned against their use in younger and active patients. Hinged implants potentially require more bone resection therefore add further to the bone loss. Use of custom-made prostheses has been described in severe bone loss.24,25 However, the pre-operative sizing of custom-made prostheses is difficult and may leave the surgeon without a solution if the custom-made implant is found not to fit.12 Meneghini, Lewallen and Hanssen26 described the successful use of porous tantalum metaphyseal cones to manage severe tibial bone loss.11 Other studies have also reported good short-term results with these devices but as yet follow-up is short (two year minimum follow up).27,28 The metaphyseal cones are impacted into the bone defect and the implant cemented into the cone. The need for allograft is reduced as the defect is largely filled with the cones, however this technique does require cement at the cone – bone interface which could diminish the potential for bone ingrowth across the cones. The important difference between cones and sleeves is that cones require cementing of the implant, while the sleeves allow direct apposition of a porous surface to host bone. In our experience, the sleeves provide a stable platform and avoid the need of excessive bone resection. Immediate weight bearing is allowed after sleeve fixation. The two sleeves that were loose in our patients did not have any stems used with them, which account for the loosening. Therefore at this preliminary stage we advocate the routine use of stems because this facilitates centralisation of the implant along the anatomical axis. However further follow-up will be needed to determine any association between absence of stems and loosening of sleeves. These early results with the use of metaphyseal sleeves are encouraging. They provided stable fixation and structural support in patients with significant metaphyseal bone loss. Different sizes of sleeves are available to address different size defects. Further follow-up will be required to evaluate the medium- and long-term results of this option. No benefits in any form have been received or will be received from a commercial party related directly or indirectly to the subject of this article. This article was primary edited by D. Rowley and first-proof edited by G. Scott.

References 1. No authors listed. National Joint Registry for England and Wales, 9th Annual report, 2012. www.njrcentre.org.uk (date last accessed 28 August 2013).

2. Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the Unites States from 2005 to 2030. J Bone Joint Surg [Am] 2007;89-A:780–785. 3. Benajamin J, Engh G, Parsley B, Donaldson T, Coon T. Morselized bone grafting in revision total knee arthroplasty. Clin Orthop Relat Res 2001;392:62–67. 4. Dorr LD, Ranawat CS, Sculso TA, McKaskill B, Orisek BS. Bone graft for tibial defects in total knee arthroplasty. Clin Orthop Relat Res 1986;205:153–165. 5. Lotke PA, Wong RY, Ecker ML. Use of methylmethacrylate in primary total knee replacement with large tibial defects. Clin Orthop Relat Res 1991;270:288–294. 6. Ghazavi MT, Stockley I, Yee G, Davis A, Gross AE. Reconstruction of massive bone defects with allograft in revision total knee arthroplasty. J Bone Joint Surg [Am] 1997;79A:17–25. 7. Hilgen V, Citak M, Vettorazzi E, et al. 10 year results following impaction bone grafting of major bone defects in 29 rotational and hinged knee revision arthroplasties: a follow up of previous report. Acta Orthop 2013;84:387–391. 8. Radnay CS, Scuderi GR. Management of bone loss: augments, cones, offset stems. Clin Orthop Relat Res 2006;446:83–92. 9. Gross TP, Liu F. Total knee arthroplasty with fully porous coated stems for the treatment of large bone defects. J Arthroplasty 2013;28:598–603. 10. Engh GA, Herzwurm PJ, Parks NL. Treatment of major bone defects of bone with bulk allografts and stemmed components during total knee arthroplasty. J Bone Joint Surg [Am] 1997;79-A:1030–1039. 11. Rao BM, Kamal TT, Vafaye J, Moss M. Tantalum cones for major osteolysis in revision knee replacement. Bone Joint J 2013;95-B:1069–1074. 12. Whittaker JP, Dharmarajan R, Toms AD. The management of bone loss in revision total knee replacement. J Bone Joint Surg [Br] 2008;90-B:981–987. 13. Dawson J, Fitzpatrick R, Murray D, Carr A. Questionnaire on the perceptions of patients about total knee replacement. J Bone Joint Surg [Br] 1998;80-B:63–69. 14. Mulhall KJ, Ghomrawi HM, Engh GA, et al. Radiographic prediction of intraoperative bone loss in knee arthroplasty revision. Clin Orthop Relat Res 2006;446:51–58. 15. Shindell R, Neumann R, Connolly JF, Jardon OM. Evaluation of the Noiles hinged knee prosthesis: a five year study of seventeen knees. J Bone Joint Surg [Am] 1986;68A:579– 585. 16. Engh GA, Ammeen DJ. Use of structural allograft in revision total knee arthroplasty in knees with severe tibial bone loss. J Bone Joint Surg [Am] 2007;89-A:2640–2647. 17. Dennis DA. The structural allograft composite in revision total knee arthroplasty. J Arthroplasty 2002;17(Suppl):90–93. 18. Wang JW, Hsu CH, Huang CC, Lin PC, Chen WS. Reconstruciton using femoral head allograft in revision total knee replacement: an experience in Asian patients. Bone Joint J 2013;95-B: 643-8:. 19. Lombardi AV, Berend KR, Adam JB. Management of bone loss in revision TKA: it's a changing world. Orthopedics 2010;33:662. 20. Brand MG, Daley RJ, Ewald FC, Scott RD. Tibial tray augmentation with modular metal wedges for tibial bone stock deficiency. Clin Orthop Relat Res 1989;248:71–79. 21. Frehill B, Crocombe A, Cirovic S, Agarwal Y, Bradley N. Initial stability of type 2 tibial defects treatments. Proc Inst Mech Eng H 2010;224:77–85. 22. Hockman DE, Ammeen D, Engh GA. Augments and allografts in revision total knee arthroplasty: usage and outcome using one modular revision prosthesis. J Arthroplasty 2005;20:35–41. 23. Pour AE, Parvizi J, Slenker N, Purtill JJ, Sharkey PF. Rotating hinged total knee replacement: use with caution. J Bone Joint Surg [Am] 2007;89-A:1735–1741. 24. Springer BD, Sim FH, Hanssen AD, Lewallen DG. The modular segmental kinematic rotating hinge for nonneoplastic limb salvage. Clin Orthop Relat Res 2004;421:181–187. 25. Harrison RJ Jr, Thacker MM, Pitcher JD, Temple HT, Scully SP. Distal femur replacement is useful in complex total knee arthroplasty revisions. Clin Orthop Relat Res 2006;446:113–120. 26. Meneghini RM, Lewallen DG, Hanssen AD. Use of porous tantalum metaphyseal cones for severe tibial bone loss during revision total knee replacement. J Bone Joint Surg [Am] 2008;90-A:78–84. 27. Long WJ, Scuderi GR. Porous tantalum cones for large metaphyseal tibial defects in revision total knee arthroplasty: a minimum 2-year follow-up. J Arthroplasty 2009;24:1086–1092. 28. Howard JL, Kudera J, Lewallen DG, Hanssen AD. Early results of use of tantalum femoral cones for revision total knee arthroplasty. J Bone Joint Surg [Am] 2011;93A:478–484.

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Metal metaphyseal sleeves in revision total knee replacement.

Bone loss in the proximal tibia and distal femur is frequently encountered in revision knee replacement surgery. The various options for dealing with ...
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