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The Bone & Joint Journal
Vol. 98-B, Issue 8 | Pages 1086 - 1092
1 Aug 2016
de Vos MJ Wagener ML Hannink G van der Pluijm M Verdonschot N Eygendaal D

Aims. Revision total elbow arthroplasty (TEA) is often challenging. The aim of this study was to report on the clinical and radiological results of revision arthroplasty of the elbow with the Latitude TEA. Patients and Methods. Between 2006 and 2010 we used the Latitude TEA for revision in 18 consecutive elbows (17 patients); mean age 53 years (28 to 80); 14 women. A Kudo TEA was revised in 15 elbows and a Souter-Strathclyde TEA in three. Stability, range of movement (ROM), visual analogue score (VAS) for pain and functional scores, Elbow Functional Assessment Scale (EFAS), the Functional Rating Index of Broberg and Morrey (FRIBM) and the Modified Andrews’ Elbow Scoring System (MAESS) were assessed pre-operatively and at each post-operative follow-up visit (six, 12 months and biennially thereafter). Radiographs were analysed for loosening, fractures and dislocation. The mean follow-up was 59 months (26 to 89). Results. The ROM of the elbow did not improve significantly. The mean EFAS and MAESS scores improved significantly six months post-operatively (18.6 points, standard deviation (. sd. ) 7.7; p = 0.03 and 28.8 points, . sd . 8.6; p = 0.006, respectively) and continued to improve slightly or reached a plateau. The mean pain scores at rest (Z = -3.2, p = 0.001) and during activity (Z = -3.2, p = 0.001), and stability (Z = -3.0, p = 0.003) improved significantly six months post-operatively. Thereafter scores continued to improve slightly or a plateau was reached. There were no signs of loosening. Conclusion. Revision surgery using the Latitude TEA results in improvement of functionality, reduced pain and better stability of the elbow. Improvement of ROM of the elbow should not be expected. Cite this article: Bone Joint J 2016;98-B:1086–92


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 946 - 950
1 May 2021
Ashdown T Hayter E Morris JA Clough OT Little M Hardman J Anakwe RE

Aims

The results of surgery for Dupuytren’s disease can be compromised by the potential for disease recurrence and loss of function. Selecting which patients will benefit from repeat surgery, when to operate, and what procedure to undertake requires judgement and an understanding of patient expectations and functional needs. We undertook this study to investigate patient outcomes and satisfaction following repeat limited fasciectomy for recurrent Dupuytren’s disease.

Methods

We prospectively identified all patients presenting with recurrence of Dupuytren’s disease who were selected for surgical treatment with repeat limited fasciectomy surgery between January 2013 and February 2015. Patients were assessed preoperatively, and again at a minimum of five years postoperatively. We identified 43 patients who were carefully selected for repeat fasciectomy involving 54 fingers. Patients with severe or aggressive disease with extensive skin involvement were not included; in our practice, these patients are instead counselled and preferentially treated with dermofasciectomy. The primary outcome measured was change in the Michigan Hand Outcomes Questionnaire (MHQ) score. Secondary outcomes were change in finger range of motion, flexion contracture, Semmes-Weinstein monofilament (SWM) values, and overall satisfaction.


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 3 | Pages 423 - 429
1 Mar 2021
Diez-Escudero A Hailer NP

Periprosthetic joint infection (PJI) is one of the most dreaded complications after arthroplasty surgery; thus numerous approaches have been undertaken to equip metal surfaces with antibacterial properties. Due to its antimicrobial effects, silver is a promising coating for metallic surfaces, and several types of silver-coated arthroplasty implants are in clinical use today. However, silver can also exert toxic effects on eukaryotic cells both in the immediate vicinity of the coated implants and systemically. In most clinically-used implants, silver coatings are applied on bulk components that are not in direct contact with bone, such as in partial or total long bone arthroplasties used in tumour or complex revision surgery. These implants differ considerably in the coating method, total silver content, and silver release rates. Safety issues, such as the occurrence of argyria, have been a cause for concern, and the efficacy of silver coatings in terms of preventing PJI is also controversial. The application of silver coatings is uncommon on parts of implants intended for cementless fixation in host bone, but this option might be highly desirable since the modification of implant surfaces in order to improve osteoconductivity can also increase bacterial adhesion. Therefore, an optimal silver content that inhibits bacterial colonization while maintaining osteoconductivity is crucial if silver were to be applied as a coating on parts intended for bone contact. This review summarizes the different methods used to apply silver coatings to arthroplasty components, with a focus on the amount and duration of silver release from the different coatings; the available experience with silver-coated implants that are in clinical use today; and future strategies to balance the effects of silver on bacteria and eukaryotic cells, and to develop silver-coated titanium components suitable for bone ingrowth.

Cite this article: Bone Joint J 2021;103-B(3):423–429.


Bone & Joint 360
Vol. 10, Issue 1 | Pages 28 - 31
1 Feb 2021


The Bone & Joint Journal
Vol. 97-B, Issue 1 | Pages 45 - 49
1 Jan 2015
Tokarski AT Novack TA Parvizi J

We hypothesised that the use of tantalum (Ta) acetabular components in revision total hip arthroplasty (THA) was protective against subsequent failure due to infection. We identified 966 patients (421 men, 545 women and 990 hips) who had undergone revision THA between 2000 and 2013. The mean follow up was 40.2 months (3 months to 13.1 years). The mean age of the men and women was 62.3 years (31 to 90) and 65.1 years (25 to 92), respectively. . Titanium (Ti) acetabular components were used in 536 hips while Ta components were used in 454 hips. In total, 73 (7.3%) hips experienced subsequent acetabular failure. The incidence of failure was lower in the Ta group at 4.4% (20/454) compared with 9.9% (53/536) in the Ti group (p < 0.001, odds ratio 2.38; 95% CI 1.37 to 4.27). Among the 144 hips (64 Ta, 80 Ti) for which revision had been performed because of infection, failure due to a subsequent infection was lower in the Ta group at 3.1% (2/64) compared with 17.5% (14/80) for the Ti group (p = 0.006). . Thus, the use of Ta acetabular components during revision THA was associated with a lower incidence of failure from all causes and Ta components were associated with a lower incidence of subsequent infection when used in patients with periprosthetic joint infection. . Cite this article: Bone Joint J 2015;97-B:45–9


The Bone & Joint Journal
Vol. 100-B, Issue 8 | Pages 1018 - 1024
1 Aug 2018
Ando W Yasui H Yamamoto K Oinuma K Tokunaga H Inaba Y Kobayashi N Aihara M Nakanishi R Ohzono K

Aims. The purpose of this study was to compare two different types of metal-on-metal (MoM) bearing for total hip arthroplasty (THA): one with a large femoral head (38 mm to 52 mm) and the other with a conventional femoral head (28 mm or 32 mm). We compared clinical outcome, blood metal ion levels, and the incidence of pseudotumour in the two groups. Patients and Methods. Between December 2009 and December 2011, 62 patients underwent MoM THA with a large femoral head (Magnum group) and 57 patients an MoM THA with a conventional femoral head (conventional group). Clinical outcome was assessed using the Harris Hip score, University of California, Los Angeles (UCLA) activity score and EuroQol-5D (EQ-5D). Blood metal ion levels were measured and MRI scans were analyzed at a minimum of five years postoperatively. Results. No acetabular component was implanted with more than 50° of inclination in either group. The Harris Hip Score, UCLA activity score, and EQ-5D improved postoperatively in both groups; no significant clinical differences were noted between the groups. The blood cobalt ion levels in the conventional group continued to rise postoperatively to five years while reaching a plateau at two years postoperatively in the Magnum group. At five years, the mean cobalt ion level of 1.16 μg/l (. sd. 1.32) in the Magnum group was significantly lower than the 3.77 μg/l (. sd. 9.80) seen in the conventional group (p = 0.0015). The incidence of moderate to severe pseudotumour was 4.7% in the Magnum group and 20.6% in the conventional group. There were no dislocations in the Magnum group and two in the conventional group. One patient in the Magnum group underwent revision for pseudotumour at 4.7 years postoperatively. Conclusion. At five years, a well-positioned large head MoM THA has a significantly lower level of metal ion release and a lower incidence of moderate to severe pseudotumour than a MoM bearing of conventional size. Cite this article: Bone Joint J 2018;100-B:1018–24


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 908 - 915
1 May 2021
O’Donnell JA Wu M Cochrane NH Belay E Myntti MF James GA Ryan SP Seyler TM

Aims

Periprosthetic joint infections (PJIs) are among the most devastating complications after joint arthroplasty. There is limited evidence on the efficacy of different antiseptic solutions on reducing biofilm burden. The purpose of the present study was to test the efficacy of different antiseptic solutions against clinically relevant microorganisms in biofilm.

Methods

We conducted an in vitro study examining the efficacy of several antiseptic solutions against clinically relevant microorganisms. We tested antiseptic irrigants against nascent (four-hour) and mature (three-day) single-species biofilm created in vitro using a drip-flow reactor model.


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 553 - 561
1 Mar 2021
Smolle MA Leithner A Kapper M Demmer G Trost C Bergovec M Windhager R Hobusch GM

Aims

The aims of the study were to analyze differences in surgical and oncological outcomes, as well as quality of life (QoL) and function in patients with ankle sarcomas undergoing three forms of surgical treatment, minor or major limb salvage surgery (LSS), or amputation.

Methods

A total of 69 patients with ankle sarcomas, treated between 1981 and 2017 at two tumour centres, were retrospectively reviewed (mean age at surgery: 46.3 years (SD 22.0); 31 females (45%)). Among these 69 patients 25 were analyzed prospectively (mean age at latest follow-up: 61.2 years (SD 20.7); 11 females (44%)), and assessed for mobility using the Prosthetic Limb Users Survey of Mobility (PLUS-M; for amputees only), the Toronto Extremity Salvage Score (TESS), and the University of California, Los Angeles (UCLA) Activity Score. Individual QoL was evaluated in these 25 patients using the five-level EuroQol five-dimension (EQ-5D-5L) and Fragebogen zur Lebenszufriedenheit/Questions on Life Satisfaction (FLZ).


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 319 - 324
1 Mar 2014
Abolghasemian M Sadeghi Naini M Tangsataporn S Lee P Backstein D Safir O Kuzyk P Gross AE

We retrospectively reviewed 44 consecutive patients (50 hips) who underwent acetabular re-revision after a failed previous revision that had been performed using structural or morcellised allograft bone, with a cage or ring for uncontained defects. Of the 50 previous revisions, 41 cages and nine rings were used with allografts for 14 minor-column and 36 major-column defects. We routinely assessed the size of the acetabular bone defect at the time of revision and re-revision surgery. This allowed us to assess whether host bone stock was restored. We also assessed the outcome of re-revision surgery in these circumstances by means of radiological characteristics, rates of failure and modes of failure. We subsequently investigated the factors that may affect the potential for the restoration of bone stock and the durability of the re-revision reconstruction using multivariate analysis. At the time of re-revision, there were ten host acetabula with no significant defects, 14 with contained defects, nine with minor-column, seven with major-column defects and ten with pelvic discontinuity. When bone defects at re-revision were compared with those at the previous revision, there was restoration of bone stock in 31 hips, deterioration of bone stock in nine and remained unchanged in ten. This was a significant improvement (p <  0.001). Morselised allografting at the index revision was not associated with the restoration of bone stock. . In 17 hips (34%), re-revision was possible using a simple acetabular component without allograft, augments, rings or cages. There were 47 patients with a mean follow-up of 70 months (6 to 146) available for survival analysis. Within this group, the successful cases had a minimum follow-up of two years after re-revision. There were 22 clinical or radiological failures (46.7%), 18 of which were due to aseptic loosening. The five and ten year Kaplan–Meier survival rate was 75% (95% CI, 60 to 86) and 56% (95% CI, 40 to 70) respectively with aseptic loosening as the endpoint. The rate of aseptic loosening was higher for hips with pelvic discontinuity (p = 0.049) and less when the allograft had been in place for longer periods (p = 0.040). . The use of a cage or ring over structural allograft bone for massive uncontained defects in acetabular revision can restore host bone stock and facilitate subsequent re-revision surgery to a certain extent. Cite this article: Bone Joint J 2014;96-B:319–24


The Bone & Joint Journal
Vol. 103-B, Issue 1 | Pages 148 - 156
1 Jan 2021
Tsirikos AI Carter TH

Aims

To report the surgical outcome of patients with severe Scheuermann’s kyphosis treated using a consistent technique and perioperative management.

Methods

We reviewed 88 consecutive patients with a severe Scheuermann's kyphosis who had undergone posterior spinal fusion with closing wedge osteotomies and hybrid instrumentation. There were 55 males and 33 females with a mean age of 15.9 years (12.0 to 24.7) at the time of surgery. We recorded their demographics, spinopelvic parameters, surgical correction, and perioperative data, and assessed the impact of surgical complications on outcome using the Scoliosis Research Society (SRS)-22 questionnaire.


Bone & Joint Research
Vol. 5, Issue 4 | Pages 122 - 129
1 Apr 2016
Small SR Rogge RD Malinzak RA Reyes EM Cook PL Farley KA Ritter MA

Objectives. Initial stability of tibial trays is crucial for long-term success of total knee arthroplasty (TKA) in both primary and revision settings. Rotating platform (RP) designs reduce torque transfer at the tibiofemoral interface. We asked if this reduced torque transfer in RP designs resulted in subsequently reduced micromotion at the cemented fixation interface between the prosthesis component and the adjacent bone. Methods. Composite tibias were implanted with fixed and RP primary and revision tibial trays and biomechanically tested under up to 2.5 kN of axial compression and 10° of external femoral component rotation. Relative micromotion between the implanted tibial tray and the neighbouring bone was quantified using high-precision digital image correlation techniques. Results. Rotational malalignment between femoral and tibial components generated 40% less overall tibial tray micromotion in RP designs than in standard fixed bearing tibial trays. RP trays reduced micromotion by up to 172 µm in axial compression and 84 µm in rotational malalignment models. Conclusions. Reduced torque transfer at the tibiofemoral interface in RP tibial trays reduces relative component micromotion and may aid long-term stability in cases of revision TKA or poor bone quality. Cite this article: Mr S. R. Small. Micromotion at the tibial plateau in primary and revision total knee arthroplasty: fixed versus rotating platform designs. Bone Joint Res 2016;5:122–129. DOI: 10.1302/2046-3758.54.2000481


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 391 - 397
1 Feb 2021
Houdek MT Wunder JS Abdel MP Griffin AM Hevesi M Rose PS Ferguson PC Lewallen DG

Aims

Hip reconstruction after resection of a periacetabular chondrosarcoma is complex and associated with a high rate of complications. Previous reports have compared no reconstruction with historical techniques that are no longer used. The aim of this study was to compare the results of tantalum acetabular reconstruction to both historical techniques and no reconstruction.

Methods

We reviewed 66 patients (45 males and 21 females) with a mean age of 53 years (24 to 81) who had undergone acetabular resection for chondrosarcoma. A total of 36 patients (54%) underwent acetabular reconstruction, most commonly with a saddle prosthesis (n = 13; 36%) or a tantalum total hip arthroplasty (THA) (n = 10; 28%). Mean follow-up was nine years (SD 4).


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 338 - 346
1 Feb 2021
Khow YZ Liow MHL Lee M Chen JY Lo NN Yeo SJ

Aims

This study aimed to identify the tibial component and femoral component coronal angles (TCCAs and FCCAs), which concomitantly are associated with the best outcomes and survivorship in a cohort of fixed-bearing, cemented, medial unicompartmental knee arthroplasties (UKAs). We also investigated the potential two-way interactions between the TCCA and FCCA.

Methods

Prospectively collected registry data involving 264 UKAs from a single institution were analyzed. The TCCAs and FCCAs were measured on postoperative radiographs and absolute angles were analyzed. Clinical assessment at six months, two years, and ten years was undertaken using the Knee Society Knee score (KSKS) and Knee Society Function score (KSFS), the Oxford Knee Score (OKS), the 36-Item Short-Form Health Survey questionnaire (SF-36), and range of motion (ROM). Fulfilment of expectations and satisfaction was also recorded. Implant survivorship was reviewed at a mean follow-up of 14 years (12 to 16). Multivariate regression models included covariates, TCCA, FCCA, and two-way interactions between them. Partial residual graphs were generated to identify angles associated with the best outcomes. Kaplan-Meier analysis was used to compare implant survivorship between groups.


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 10 | Pages 1382 - 1389
1 Oct 2012
Sewell MD Kang SN Al-Hadithy N Higgs DS Bayley I Falworth M Lambert SM

There is little information about the management of peri-prosthetic fracture of the humerus after total shoulder replacement (TSR). This is a retrospective review of 22 patients who underwent a revision of their original shoulder replacement for peri-prosthetic fracture of the humerus with bone loss and/or loose components. There were 20 women and two men with a mean age of 75 years (61 to 90) and a mean follow-up 42 months (12 to 91): 16 of these had undergone a previous revision TSR. Of the 22 patients, 12 were treated with a long-stemmed humeral component that bypassed the fracture. All their fractures united after a mean of 27 weeks (13 to 94). Eight patients underwent resection of the proximal humerus with endoprosthetic replacement to the level of the fracture. Two patients were managed with a clam-shell prosthesis that retained the original components. The mean Oxford shoulder score (OSS) of the original TSRs before peri-prosthetic fracture was 33 (14 to 48). The mean OSS after revision for fracture was 25 (9 to 31). Kaplan-Meier survival using re-intervention for any reason as the endpoint was 91% (95% confidence interval (CI) 68 to 98) and 60% (95% CI 30 to 80) at one and five years, respectively. There were two revisions for dislocation of the humeral head, one open reduction for modular humeral component dissociation, one internal fixation for nonunion, one trimming of a prominent screw and one re-cementation for aseptic loosening complicated by infection, ultimately requiring excision arthroplasty. Two patients sustained nerve palsies. Revision TSR after a peri-prosthetic humeral fracture associated with bone loss and/or loose components is a salvage procedure that can provide a stable platform for elbow and hand function. Good rates of union can be achieved using a stem that bypasses the fracture. There is a high rate of complications and function is not as good as with the original replacement


Bone & Joint Research
Vol. 5, Issue 4 | Pages 145 - 152
1 Apr 2016
Bodalia PN Balaji V Kaila R Wilson L

Objectives. We performed a systematic review of the literature to determine the safety and efficacy of bone morphogenetic protein (BMP) compared with bone graft when used specifically for revision spinal fusion surgery secondary to pseudarthrosis. Methods. The MEDLINE, EMBASE and Cochrane Library databases were searched using defined search terms. The primary outcome measure was spinal fusion, assessed as success or failure in accordance with radiograph, MRI or CT scan review at 24-month follow-up. The secondary outcome measure was time to fusion. Results. A total of six studies (three prospective and three retrospective) reporting on the use of BMP2 met the inclusion criteria (203 patients). Of these, four provided a comparison of BMP2 and bone graft whereas the other two solely investigated the use of BMP2. The primary outcome was seen in 92.3% (108/117) of patients following surgery with BMP2. Although none of the studies showed superiority of BMP2 to bone graft for fusion, its use was associated with a statistically quicker time to achieving fusion. BMP2 did not appear to increase the risk of complication. Conclusion. The use of BMP2 is both safe and effective within the revision setting, ideally in cases where bone graft is unavailable or undesirable. Further research is required to define its optimum role. Cite this article: Mr P. Bodalia. Effectiveness and safety of recombinant human bone morphogenetic protein-2 for adults with lumbar spine pseudarthrosis following spinal fusion surgery: A systematic review. Bone Joint Res 2016;5:145–152. DOI: 10.1302/2046-3758.54.2000418


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 207 - 212
1 Feb 2021
Hurley ET Stewart SK Kennedy JG Strauss EJ Calder J Ramasamy A

The management of symptomatic osteochondral lesions of the talus (OLTs) can be challenging. The number of ways of treating these lesions has increased considerably during the last decade, with published studies often providing conflicting, low-level evidence. This paper aims to present an up-to-date concise overview of the best evidence for the surgical treatment of OLTs. Management options are reviewed based on the size of the lesion and include bone marrow stimulation, bone grafting options, drilling techniques, biological preparations, and resurfacing. Although many of these techniques have shown promising results, there remains little high level evidence, and further large scale prospective studies and systematic reviews will be required to identify the optimal form of treatment for these lesions.

Cite this article: Bone Joint J 2021;103-B(2):207–212.


The Bone & Joint Journal
Vol. 103-B, Issue 3 | Pages 500 - 506
1 Mar 2021
Leonard HJ Ohly NE

Aims

The purpose of this study was to compare the clinical, radiological, and patient-reported outcome measures (PROMs) in the first 100 consecutive patients undergoing total hip arthroplasty (THA) via a direct superior approach (DSA) with a matched group of patients undergoing THA by the same surgeon, using a posterolateral approach (PLA).

Methods

This was a retrospective single surgeon study comparing the first 100 consecutive DSA THA patients with a matched group of patients using a standard PLA. Case notes were examined for patient demographics, length of hospital stay, operating time, intra- and postoperative complications, pain score, satisfaction score, and Oxford Hip Score (OHS). Leg length discrepancy and component positioning were measured from postoperative plain radiographs.


The Bone & Joint Journal
Vol. 96-B, Issue 11 | Pages 1449 - 1454
1 Nov 2014
Imbuldeniya AM Walter WL Zicat BA Walter WK

We describe the clinical and radiological results of cementless primary total hip replacement (THR) in 25 patients (18 women and seven men; 30 THRs) with severe developmental dysplasia of the hip (DDH). Their mean age at surgery was 47 years (23 to 89). In all, 21 hips had Crowe type III dysplasia and nine had Crowe type IV. Cementless acetabular components with standard polyethylene liners were introduced as close to the level of the true acetabulum as possible. The modular cementless S-ROM femoral component was used with a low resection of the femoral neck. A total of 21 patients (25 THRs) were available for review at a mean follow-up of 18.7 years (15.8 to 21.8). The mean modified Harris hip score improved from 46 points pre-operatively to 90 at final follow up (p < 0.001). . A total of 15 patients (17 THRs; 57%) underwent revision of the acetabular component at a mean of 14.6 years (7 to 20.8), all for osteolysis. Two patients (two THRs) had symptomatic loosening. No patient underwent femoral revision. Survival with revision of either component for any indication was 81% at 15 years (95% CI 60.1 to 92.3), with 21 patients at risk. . This technique may reduce the need for femoral osteotomy in severe DDH, while providing a good long-term functional result. Cite this article: Bone Joint J 2014;96-B:1449–54


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 10 | Pages 1411 - 1415
1 Oct 2011
Wainwright C Theis J Garneti N Melloh M

We compared revision and mortality rates of 4668 patients undergoing primary total hip and knee replacement between 1989 and 2007 at a University Hospital in New Zealand. The mean age at the time of surgery was 69 years (16 to 100). A total of 1175 patients (25%) had died at follow-up at a mean of ten years post-operatively. The mean age of those who died within ten years of surgery was 74.4 years (29 to 97) at time of surgery. No change in comorbidity score or age of the patients receiving joint replacement was noted during the study period. No association of revision or death could be proven with higher comorbidity scoring, grade of surgeon, or patient gender. We found that patients younger than 50 years at the time of surgery have a greater chance of requiring a revision than of dying, those around 58 years of age have a 50:50 chance of needing a revision, and in those older than 62 years the prosthesis will normally outlast the patient. Patients over 77 years old have a greater than 90% chance of dying than requiring a revision whereas those around 47 years are on average twice as likely to require a revision than die. This information can be used to rationalise the need for long-term surveillance and during the informed consent process