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The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 933 - 940
1 Jul 2020
Maempel JF Clement ND Wickramasinghe NR Duckworth AD Keating JF

Aims. The aim was to compare long-term patient-reported outcome measures (PROMs) after operative and nonoperative treatment of acute Achilles tendon rupture in the context of a randomized controlled trial. Methods. PROMs including the Short Musculoskeletal Function Assessment (SMFA), Achilles Tendon Total Rupture Score (ATRS), EuroQol five-dimension (EQ-5D), satisfaction, net promoter score and data regarding re-rupture, and venous thromboembolic rates were collected for patients randomized to receive either operative or nonoperative treatment for acute Achilles tendon rupture in a previous study. Of the 80 patients originally randomized, 64 (33 treated surgically, 31 nonoperatively) patients were followed up at a mean of 15.7 years (13.4 to 17.7). Results. There was no statistically significant difference between operatively and nonoperatively treated patients, in SMFA Dysfunction Index (median 1.56 (interquartile range (IQR) 0 to 5.51) vs 1.47 (IQR 0 to 5.15); p = 0.289), SMFA Bother Index (2.08 (IQR 0 to 12.50) vs 0.00 (IQR 0 to 6.25); p = 0.074), ATRS (94 (IQR 86 to 100) vs 95 (IQR 81 to 100); p = 0.313), EQ-5D-5L (1 (IQR 0.75 to 1) vs 1 (IQR 0.84 to 1); p = 0.137) or EQ-5D health today visual analogue score (85 (IQR 72.5 to 95) vs 85 (IQR 8 to 95); p = 0.367). There was no statistically significant difference between operative and nonoperative groups in terms of satisfaction (84% vs 100%; p = 0.119) or willingness to recommend treatment to friends or family (79% vs 87%; p = 0.255). Four nonoperative patients and two in the operative group sustained a re-rupture (p = 0.306). Conclusion. Both patient groups reported good results at long-term follow-up. The findings give no evidence of superior long-term patient reported outcomes (as measured by the SMFA) for surgical treatment over nonoperative treatment. There was no demonstrable difference in other patient reported outcome measures, satisfaction, or re-rupture rates at long-term follow-up. Cite this article: Bone Joint J 2020;102-B(7):933–940


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 8 | Pages 1071 - 1078
1 Aug 2011
Keating JF Will EM

A total of 80 patients with an acute rupture of tendo Achillis were randomised to operative repair using an open technique (39 patients) or non-operative treatment in a cast (41 patients). Patients were followed up for one year. Outcome measures included clinical complications, range of movement of the ankle, the Short Musculoskeletal Function Assessment (SMFA), and muscle function dynamometry evaluating dorsiflexion and plantar flexion of the ankle. The primary outcome measure was muscle dynamometry. Re-rupture occurred in two of 37 patients (5%) in the operative group and four of 39 (10%) in the non-operative group, which was not statistically significant (p = 0.68). There was a slightly greater range of plantar flexion and dorsiflexion of the ankle in the operative group at three months which was not statistically significant, but at four and six months the range of dorsiflexion was better in the non-operative group, although this did not reach statistically significance either. After 12 weeks the peak torque difference of plantar flexion compared with the normal side was less in the operative than the non-operative group (47% vs 61%, respectively, p < 0.005). The difference declined to 26% and 30% at 26 weeks and 20% and 25% at 52 weeks, respectively. The difference in dorsiflexion peak torque from the normal side was less than 10% by 26 weeks in both groups, with no significant differences. The mean SMFA scores were significantly better in the operative group than the non-operative group at three months (15 vs 20, respectively, p < 0.03). No significant differences were observed after this, and at one year the scores were similar in both groups. We were unable to show a convincing functional benefit from surgery for patients with an acute rupture of the tendo Achillis compared with conservative treatment in plaster


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 636 - 640
1 May 2014
Korim MT Payne R Bhatia M

Most of the literature on surgical site infections following the surgical treatment of fractures of the ankle is based on small series of patients, focusing on diabetics or the elderly. None have described post-operative functional scores in those patients who develop an infection. We performed an age- and gender-matched case–control study to identify patient- and surgery-related risk factors for surgical site infection following open reduction and internal fixation of a fracture of the ankle. Logistic regression analysis was used to identify significant risk factors for infection and to calculate odds ratios (OR). Function was assessed using the Olerud and Molander Ankle Score. The incidence of infection was 4% (29/717) and 1.1% (8/717) were deep infections. The median ankle score was significantly lower in the infection group compared with the control group (60 vs 90, Mann–Whitney test p < 0.0001). Multivariate regression analysis showed that diabetes (OR = 15, p = 0.031), nursing home residence (OR = 12, p = 0.018) and Weber C fractures (OR = 4, p = 0.048) were significant risk factors for infection.

A low incidence of infection following open reduction and internal fixation of fractures of the ankle was observed. Both superficial and deep infections result in lower functional scores.

Cite this article: Bone Joint J 2014;96-B:636–40.


The Bone & Joint Journal
Vol. 105-B, Issue 4 | Pages 382 - 388
15 Mar 2023
Haque A Parsons H Parsons N Costa ML Redmond AC Mason J Nwankwo H Kearney RS

Aims. The aim of this study was to compare the longer-term outcomes of operatively and nonoperatively managed patients treated with a removable brace (fixed-angle removable orthosis) or a plaster cast immobilization for an acute ankle fracture. Methods. This is a secondary analysis of a multicentre randomized controlled trial comparing adults with an acute ankle fracture, initially managed either by operative or nonoperative care. Patients were randomly allocated to receive either a cast immobilization or a fixed-angle removable orthosis (removable brace). Data were collected on baseline characteristics, ankle function, quality of life, and complications. The Olerud-Molander Ankle Score (OMAS) was the primary outcome which was used to measure the participant’s ankle function. The primary endpoint was at 16 weeks, with longer-term follow-up at 24 weeks and two years. Results. Overall, 436 patients (65%) completed the final two-year follow-up. The mean difference in OMAS at two years was -0.3 points favouring the plaster cast (95% confidence interval -3.9 to 3.4), indicating no statistically significant difference between the interventions. There was no evidence of differences in patient quality of life (measured using the EuroQol five-dimension five-level questionnaire) or Disability Rating Index. Conclusion. This study demonstrated that patients treated with a removable brace had similar outcomes to those treated with a plaster cast in the first two years after injury. A removable brace is an effective alternative to traditional immobilization in a plaster cast for patients with an ankle fracture. Cite this article: Bone Joint J 2023;105-B(4):382–388


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 942 - 948
1 Sep 2024
Kingery MT Kadiyala ML Walls R Ganta A Konda SR Egol KA

Aims. This study evaluated the effect of treating clinician speciality on management of zone 2 fifth metatarsal fractures. Methods. This was a retrospective cohort study of patients with acute zone 2 fifth metatarsal fractures who presented to a single large, urban, academic medical centre between December 2012 and April 2022. Zone 2 was the region of the fifth metatarsal base bordered by the fourth and fifth metatarsal articulation on the oblique radiograph. The proportion of patients allowed to bear weight as tolerated immediately after injury was compared between patients treated by orthopaedic surgeons and podiatrists. The effects of unrestricted weightbearing and foot and/or ankle immobilization on clinical healing were assessed. A total of 487 patients with zone 2 fractures were included (mean age 53.5 years (SD 16.9), mean BMI 27.2 kg/m. 2. (SD 6.0)) with a mean follow-up duration of 2.57 years (SD 2.64). Results. Overall, 281 patients (57.7%) were treated by orthopaedic surgeons, and 206 patients (42.3%) by podiatrists. When controlling for age, sex, and time between symptom onset and presentation, the likelihood of undergoing operative treatment was significantly greater when treated by a podiatrist (odds ratio (OR) 2.9 (95% CI 1.2 to 8.2); p = 0.029). A greater proportion of patients treated by orthopaedic surgeons were allowed to immediately bear weight on the injured foot (70.9% (178/251) vs 47.3% (71/150); p < 0.001). Patients treated by podiatrists were immobilized for significantly longer (mean 8.4 weeks (SD 5.7) vs 6.8 weeks (SD 4.3); p = 0.002) and experienced a significantly longer mean time to clinical healing (12.1 (SD 10.6) vs 9.0 weeks (SD 7.3), p = 0.003). Conclusion. Although there was considerable heterogeneity among zone 2 fracture management, orthopaedic surgeons were less likely to treat patients operatively and more likely to allow early full weightbearing compared to podiatrists. Cite this article: Bone Joint J 2024;106-B(9):942–948


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1099 - 1107
1 Oct 2023
Henry JK Shaffrey I Wishman M Palma Munita J Zhu J Cody E Ellis S Deland J Demetracopoulos C

Aims

The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

Methods

This is a single-centre retrospective review of patients who underwent primary total ankle arthroplasty (TAA) with a Vantage implant between November 2017 and February 2020, with a minimum of two years’ follow-up. Four surgeons contributed patients. The primary outcome was reoperation and revision rate of the Vantage implant at two years. Secondary outcomes included radiological alignment, peri-implant complications, and pre- and postoperative patient-reported outcomes.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1535 - 1541
1 Nov 2020
Yassin M Myatt R Thomas W Gupta V Hoque T Mahadevan D

Aims. Functional rehabilitation has become an increasingly popular treatment for Achilles tendon rupture (ATR), providing comparably low re-rupture rates to surgery, while avoiding risks of surgical complications. Limited evidence exists on whether gap size should affect patient selection for this treatment option. The aim of this study was to assess if size of gap between ruptured tendon ends affects patient-reported outcome following ATR treated with functional rehabilitation. Methods. Analysis of prospectively collected data on all 131 patients diagnosed with ATR at Royal Berkshire Hospital, UK, from August 2016 to January 2019 and managed non-operatively was performed. Diagnosis was confirmed on all patients by dynamic ultrasound scanning and gap size measured with ankle in full plantarflexion. Functional rehabilitation using an established protocol was the preferred treatment. All non-operatively treated patients with completed Achilles Tendon Rupture Scores (ATRS) at a minimum of 12 months following injury were included. Results. In all, 82 patients with completed ATRS were included in the analysis. Their mean age was 51 years (standard deviation (SD) 14). The mean ATRS was 76 (SD 19) at a mean follow-up of 20 months (SD 11) following injury. Gap inversely affected ATRS with a Pearson’s correlation of -0.30 (p = 0.008). Mean ATRS was lower with gaps > 5 mm compared with ≤ 5 mm (73 (SD 21) vs 82 (SD 16); p = 0.031). Mean ATRS was lowest (70 (SD 23)) with gaps > 10 mm, with significant differences in perceived strength and pain. The overall re-rupture rate was two out of 131 (1.5%). Conclusion. Increasing gap size predicts lower patient-reported outcome, as measured by ATRS. Tendon gap > 5 mm may be a useful predictor in physically demanding individuals, and tendon gap > 10 mm for those with low physical demand. Further studies that control for gap size when comparing non-operative and operative treatment are required to assess if these patients may benefit from surgery, particularly when balanced against the surgical risks. Cite this article: Bone Joint J 2020;102-B(11):1535–1541


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 256 - 261
1 Mar 2024
Goodall R Borsky K Harrison CJ Welck M Malhotra K Rodrigues JN

Aims

The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual’s response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ.

Methods

This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed.


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 985 - 992
1 Sep 2023
Arshad Z Haq II Bhatia M

Aims

This scoping review aims to identify patient-related factors associated with a poorer outcome following total ankle arthroplasty (TAA).

Methods

A scoping review was performed using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A computer-based literature search was performed in PubMed, Embase, Cochrane trials, and Web of Science. Two reviewers independently performed title/abstract and full-text screening according to predetermined selection criteria. English-language original research studies reporting patient-related factors associated with a poorer outcome following TAA were included. Outcomes were defined as patient-reported outcome measures (PROMs), perioperative complications, and failure.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 301 - 306
1 Mar 2023
Jennison T Ukoumunne O Lamb S Sharpe I Goldberg AJ

Aims

Despite the increasing numbers of ankle arthroplasties, there are limited studies on their survival and comparisons between different implants. The primary aim of this study was to determine the failure rates of primary ankle arthroplasties commonly used in the UK.

Methods

A data linkage study combined National Joint Registry (NJR) data and NHS Digital data. The primary outcome of failure was defined as the removal or exchange of any components of the implanted device. Life tables and Kaplan-Meier survival charts were used to illustrate survivorship. Cox proportional hazards regression models were fitted to compare failure rates between 1 April 2010 and 31 December 2018.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1443 - 1450
1 Dec 2024
Down B Ferguson J Loizou C McNally M Ramsden A Stubbs D Kendal A

Aims

Calcaneal osteomyelitis remains a difficult condition to treat with high rates of recurrence and below-knee amputation, particularly in the presence of severe soft-tissue destruction. This study assesses the outcomes of single-stage orthoplastic surgical treatment of calcaneal osteomyelitis with large soft-tissue defects.

Methods

A retrospective review was performed of all patients who underwent combined single-stage orthoplastic treatment of calcaneal osteomyelitis (01/2008 to 12/2022). Primary outcome measures were osteomyelitis recurrence and below-knee amputation (BKA). Secondary outcome measures included flap failure, operating time, complications, and length of stay.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 949 - 956
1 Sep 2024
Matthews PA Scammell BE Coughlin TA Nightingale J Ollivere BJ

Aims

This study aimed to compare the outcomes of two different postoperative management approaches following surgical fixation of ankle fractures: traditional cast immobilization versus the Early Motion and Directed Exercise (EMADE) programme.

Methods

A total of 157 patients aged 18 years or older who underwent successful open reduction and internal fixation (ORIF) of Weber B (AO44B) ankle fractures were recruited to this randomized controlled trial. At two weeks post-surgical fixation, participants were randomized to either light-weight cast-immobilization or the EMADE programme, consisting of progressive home exercises and weekly advice and education. Both groups were restricted to non-weightbearing until six weeks post-surgery. The primary outcome was assessed using the Olerud-Molander Ankle Score (OMAS) questionnaire at 12 weeks post-surgery, with secondary measures at two, six, 24, and 52 weeks. Exploratory cost-effectiveness analyses were also performed.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1689 - 1696
1 Dec 2020
Halai MM Pinsker E Mann MA Daniels TR

Aims. Preoperative talar valgus deformity ≥ 15° is considered a contraindication for total ankle arthroplasty (TAA). We compared operative procedures and clinical outcomes of TAA in patients with talar valgus deformity ≥ 15° and < 15°. Methods. A matched cohort of patients similar for demographics and components used but differing in preoperative coronal-plane tibiotalar valgus deformity ≥ 15° (valgus, n = 50; 52% male, mean age 65.8 years (SD 10.3), mean body mass index (BMI) 29.4 (SD 5.2)) or < 15° (control, n = 50; 58% male, mean age 65.6 years (SD 9.8), mean BMI 28.7 (SD 4.2)), underwent TAA by one surgeon. Preoperative and postoperative radiographs, Ankle Osteoarthritis Scale (AOS) pain and disability and 36-item Short Form Health Survey (SF-36) version 2 scores were collected prospectively. Ancillary procedures, secondary procedures, and complications were recorded. Results. At mean 5.1 years follow-up (SD 2.6) (valgus) and 6.6 years (SD 3.3) (controls), mean AOS scores decreased and SF-36 scores increased significantly in both groups. Improvements in scores were similar for both groups – AOS pain: valgus, mean 26.2 points (SD 24.2), controls, mean 22.3 points (SD 26.4); AOS disability: valgus, mean 41.2 points (SD 25.6); controls, mean 34.6 points (SD 24.3); and SF-36 PCS: valgus, mean 9.1 points (SD 14.1), controls, mean 7.4 points (SD 9.8). Valgus ankles underwent more ancillary procedures during TAA (40 (80%) vs 13 (26%)) and more secondary procedures postoperatively (18 (36%) vs 7 (14%)) than controls. Tibiotalar deformity improved significantly (p < 0.001) towards a normal weightbearing axis in valgus ankles. Three valgus and four control ankles required subsequent fusion, including two for deep infections (one in each group). Conclusion. Satisfactory mid-term results were achieved in patients with preoperative valgus malalignment ≥ 15°, but they required more adjunctive procedures during and after TAA. Valgus coronal-plane deformity ≥ 15° is not an absolute contraindication for TAA if associated deformities are addressed. Cite this article: Bone Joint J 2020;102-B(12):1689–1696


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 895 - 904
1 Aug 2023
Smith TO Dainty J Loveday DT Toms A Goldberg AJ Watts L Pennington MW Dawson J van der Meulen J MacGregor AJ

Aims

The aim of this study was to capture 12-month outcomes from a representative multicentre cohort of patients undergoing total ankle arthroplasty (TAA), describe the pattern of patient-reported outcome measures (PROMs) at 12 months, and identify predictors of these outcome measures.

Methods

Patients listed for a primary TAA at 19 NHS hospitals between February 2016 and October 2017 were eligible. PROMs data were collected preoperatively and at six and 12 months including: Manchester-Oxford Foot and Ankle Questionnaire (MOXFQ (foot and ankle)) and the EuroQol five-dimension five-level questionnaire (EQ-5D-5L). Radiological pre- and postoperative data included Kellgren-Lawrence score and implant position measurement. This was supplemented by data from the National Joint Registry through record linkage to determine: American Society of Anesthesiologists (ASA) grade at index procedure; indication for surgery, index ankle previous fracture; tibial hind foot alignment; additional surgery at the time of TAA; and implant type. Multivariate regression models assessed outcomes, and the relationship between MOXFQ and EQ-5D-5L outcomes, with patient characteristics.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1431 - 1442
1 Dec 2024
Poutoglidou F van Groningen B McMenemy L Elliot R Marsland D

Lisfranc injuries were previously described as fracture-dislocations of the tarsometatarsal joints. With advancements in modern imaging, subtle Lisfranc injuries are now more frequently recognized, revealing that their true incidence is much higher than previously thought. Injury patterns can vary widely in severity and anatomy. Early diagnosis and treatment are essential to achieve good outcomes. The original classification systems were anatomy-based, and limited as tools for guiding treatment. The current review, using the best available evidence, instead introduces a stability-based classification system, with weightbearing radiographs and CT serving as key diagnostic tools. Stable injuries generally have good outcomes with nonoperative management, most reliably treated with immobilization and non-weightbearing for six weeks. Displaced or comminuted injuries require surgical intervention, with open reduction and internal fixation (ORIF) being the most common approach, with a consensus towards bridge plating. While ORIF generally achieves satisfactory results, its effectiveness can vary, particularly in high-energy injuries. Primary arthrodesis remains niche for the treatment of acute injuries, but may offer benefits such as lower rates of post-traumatic arthritis and hardware removal. Novel fixation techniques, including suture button fixation, aim to provide flexible stabilization, which theoretically could improve midfoot biomechanics and reduce complications. Early findings suggest promising functional outcomes, but further studies are required to validate this method compared with established techniques. Future research should focus on refining stability-based classification systems, validation of weightbearing CT, improving rehabilitation protocols, and optimizing surgical techniques for various injury patterns to ultimately enhance patient outcomes.

Cite this article: Bone Joint J 2024;106-B(12):1431–1442.


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 703 - 708
1 Jun 2022
Najefi A Zaidi R Chan O Hester T Kavarthapu V

Aims

Surgical reconstruction of deformed Charcot feet carries a high risk of nonunion, metalwork failure, and deformity recurrence. The primary aim of this study was to identify the factors contributing to these complications following hindfoot Charcot reconstructions.

Methods

We retrospectively analyzed patients who underwent hindfoot Charcot reconstruction with an intramedullary nail between January 2007 and December 2019 in our unit. Patient demographic details, comorbidities, weightbearing status, and postoperative complications were noted. Metalwork breakage, nonunion, deformity recurrence, concurrent midfoot reconstruction, and the measurements related to intramedullary nail were also recorded.


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 472 - 478
1 Apr 2022
Maccario C Paoli T Romano F D’Ambrosi R Indino C Federico UG

Aims

This study reports updates the previously published two-year clinical, functional, and radiological results of a group of patients who underwent transfibular total ankle arthroplasty (TAA), with follow-up extended to a minimum of five years.

Methods

We prospectively evaluated 89 patients who underwent transfibular TAA for end-stage osteoarthritis. Patients’ clinical and radiological examinations were collected pre- and postoperatively at six months and then annually for up to five years of follow-up. Three patients were lost at the final follow-up with a total of 86 patients at the final follow-up.


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 6 | Pages 772 - 777
1 Jun 2007
von Knoch F Reckord U von Knoch M Sommer C

We investigated the clinical and radiological outcome after unilateral fracture of the lateral process of the talus in 23 snowboarders with a mean follow-up of 3.5 years (12 to 76 months). In this consecutive cohort study both operative and non-operative cases were considered. The mean American Orthopaedic Foot and Ankle Society hindfoot score was 94 (82 to 100). The non-operative group of seven with a minimally-displaced fracture scored higher (98 points) than the operative group of 16 with displaced or unstable fractures (93 points). In 88% of operative cases, significant concomitant hindfoot injuries were found at operation. All but eight (35%) patients (six operative and two non-operative) regained their pre-injury level of sporting activity. Subtalar osteoarthritis was present in nine (45%) of the 20 patients available for radiological review, including one late-diagnosed non-operative case and eight operative cases with associated injuries or fracture comminution. The outcome after fracture of the lateral process of the talus in snowboarders is favourable provided an early diagnosis is made and adequate treatment, which is related to the degree of displacement and associated injuries, is undertaken


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1611 - 1618
1 Oct 2021
Kavarthapu V Budair B

Aims

In our unit, we adopt a two-stage surgical reconstruction approach using internal fixation for the management of infected Charcot foot deformity. We evaluate our experience with this functional limb salvage method.

Methods

We conducted a retrospective analysis of prospectively collected data of all patients with infected Charcot foot deformity who underwent two-stage reconstruction with internal fixation between July 2011 and November 2019, with a minimum of 12 months’ follow-up.


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 696 - 703
1 Apr 2021
Clough TM Ring J

Aims

We report the medium-term outcomes of a consecutive series of 118 Zenith total ankle arthroplasties (TAAs) from a single, non-designer centre.

Methods

Between December 2010 and May 2016, 118 consecutive Zenith prostheses were implanted in 114 patients. Demographic, clinical, and patient-reported outcome measures (PROMs) data were collected. The endpoint of the study was failure of the implant requiring revision of one or all of the components. Kaplan-Meier survival curves were generated with 95% confidence intervals (CIs) and the rate of failure calculated for each year.