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The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1416 - 1425
1 Dec 2024
Stroobant L Jacobs E Arnout N Van Onsem S Tampere T Burssens A Witvrouw E Victor J

Aims

Approximately 10% to 20% of knee arthroplasty patients are not satisfied with the result, while a clear indication for revision surgery might not be present. Therapeutic options for these patients, who often lack adequate quadriceps strength, are limited. Therefore, the primary aim of this study was to evaluate the clinical effect of a novel rehabilitation protocol that combines low-load resistance training (LL-RT) with blood flow restriction (BFR).

Methods

Between May 2022 and March 2024, we enrolled 45 dissatisfied knee arthroplasty patients who lacked any clear indication for revision to this prospective cohort study. All patients were at least six months post-surgery and had undergone conventional physiotherapy previously. The patients participated in a supervised LL-RT combined with BFR in 18 sessions. Primary assessments included the following patient-reported outcome measures (PROMs): Knee injury and Osteoarthritis Outcome Score (KOOS); Knee Society Score: satisfaction (KSSs); the EuroQol five-dimension five-level questionnaire (EQ-5D-5L); and the pain catastrophizing scale (PCS). Functionality was assessed using the six-minute walk Test (6MWT) and the 30-second chair stand test (30CST). Follow-up timepoints were at baseline, six weeks, three months, and six months after the start.


The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1451 - 1460
1 Dec 2024
Mandalia K Le Breton S Roche C Shah SS

Aims

A recent study used the RAND Corporation at University of California, Los Angeles (RAND/UCLA) method to develop anatomical total shoulder arthroplasty (aTSA) appropriateness criteria. The purpose of our study was to determine how patient-reported outcome measures (PROMs) vary based on appropriateness.

Methods

Clinical data from a multicentre database identified patients who underwent primary aTSA from November 2004 to January 2023. A total of 390 patients (mean follow-up 48.1 months (SD 42.0)) were included: 97 (24.9%) were classified as appropriate, 218 (55.9%) inconclusive, and 75 (19.2%) inappropriate. Patients were classified as “appropriate”, “inconclusive”, or “inappropriate”, using a modified version of an appropriateness algorithm, which accounted for age, rotator cuff status, mobility, symptomatology, and Walch classification. Multiple pre- and postoperative scores were analyzed using Pearson’s chi-squared test and one-way analysis of variance (ANOVA). Postoperative complications were also analyzed.


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. 106-B, Issue 11 | Pages 1263 - 1272
1 Nov 2024
Amador IE Hao KA Buchanan TR Damrow DS Hones KM Simcox T Schoch BS Farmer KW Wright TW LaMonica TJ King JJ Wright JO

Aims

We sought to compare functional outcomes and survival between non-smokers, former smokers, and current smokers who underwent anatomical total shoulder arthroplasty (aTSA) in a large cohort of patients.

Methods

A retrospective review of a prospectively collected shoulder arthroplasty database was performed between August 1991 and September 2020 to identify patients who underwent primary aTSA. Patients were excluded for preoperative diagnoses of fracture, infection, or oncological disease. Three cohorts were created based on smoking status: non-smokers, former smokers, and current smokers. Outcome scores (American Shoulder and Elbow Surgeons (ASES), Constant-Murley score, Shoulder Pain and Disability Index (SPADI), Simple Shoulder Test (SST), University of California, Los Angeles activity scale (UCLA)), range of motion (external rotation (ER), forward elevation (FE), internal rotation, abduction), and shoulder strength (ER, FE) evaluated at two- to four-year follow-up were compared between cohorts. Evaluation of revision-free survival was performed using the Kaplan-Meier method to final follow-up.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1206 - 1215
1 Nov 2024
Fontalis A Buchalter D Mancino F Shen T Sculco PK Mayman D Haddad FS Vigdorchik J

Understanding spinopelvic mechanics is important for the success of total hip arthroplasty (THA). Despite significant advancements in appreciating spinopelvic balance, numerous challenges remain. It is crucial to recognize the individual variability and postoperative changes in spinopelvic parameters and their consequential impact on prosthetic component positioning to mitigate the risk of dislocation and enhance postoperative outcomes. This review describes the integration of advanced diagnostic approaches, enhanced technology, implant considerations, and surgical planning, all tailored to the unique anatomy and biomechanics of each patient. It underscores the importance of accurately predicting postoperative spinopelvic mechanics, selecting suitable imaging techniques, establishing a consistent nomenclature for spinopelvic stiffness, and considering implant-specific strategies. Furthermore, it highlights the potential of artificial intelligence to personalize care.

Cite this article: Bone Joint J 2024;106-B(11):1206–1215.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1301 - 1305
1 Nov 2024
Prajapati A Thakur RPS Gulia A Puri A

Aims. Reconstruction after osteoarticular resection of the proximal ulna for tumours is technically difficult and little has been written about the options that are available. We report a series of four patients who underwent radial neck to humeral trochlea transposition arthroplasty following proximal ulnar osteoarticular resection. Methods. Between July 2020 and July 2022, four patients with primary bone tumours of the ulna underwent radial neck to humeral trochlea transposition arthroplasty. Their mean age was 28 years (12 to 41). The functional outcome was assessed using the range of motion (ROM) of the elbow, rotation of the forearm and stability of the elbow, the Musculoskeletal Tumor Society score (MSTS), and the nine-item abbreviated version of the Disabilities of the Arm, Shoulder and Hand questionnaire (QuickDASH-9) score. Results. All patients were available for follow-up at a mean of 33 months (25 to 43) and were disease-free. The mean flexion arc was 0° to 105°. Three patients had complications. One had neuropraxia of the ulnar nerve. The symptoms resolved after three months. In one patient, the screw used for fixation of the triceps tendon became exposed and was removed, six months postoperatively. One patient with wound dehiscence required a local flap for soft-tissue cover, four months postoperatively. At a mean follow-up of 33 months (25 to 43), the mean flexion arc was 0° to 105°. All patients had full supination (85°) but none had any pronation. The mean MSTS score was 23.5 (23 to 24) and mean QuickDASH-9 score was 26.13 (16.5 to 35.75). Three patients had varus-valgus instability on examination, although only one had a sense of instability while working. Conclusion. Radial neck to humeral trochlea transposition offers a satisfactory and cost-effective biological reconstructive option after osteoarticular resection of the proximal ulna, in the short term. It provides good elbow function and, being a biological reconstruction option using native bone, is likely to provide long-term stability and durability. Cite this article: Bone Joint J 2024;106-B(11):1301–1305


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1293 - 1300
1 Nov 2024
O’Malley O Craven J Davies A Sabharwal S Reilly P

Aims

Reverse shoulder arthroplasty (RSA) has become the most common type of shoulder arthroplasty used in the UK, and a better understanding of the outcomes after revision of a failed RSA is needed. The aim of this study was to review the current evidence systematically to determine patient-reported outcome measures and the rates of re-revision and complications for patients undergoing revision of a RSA.

Methods

MEDLINE, Embase, CENTRAL, and the Cochrane Database of Systematic Reviews were searched. Studies involving adult patients who underwent revision of a primary RSA for any indication were included. Those who underwent a RSA for failure of a total shoulder arthroplasty or hemiarthroplasty were excluded. Pre- and postoperative shoulder scores were evaluated in a random effects meta-analysis to determine the mean difference. The rates of re-revision and complications were also calculated.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1240 - 1248
1 Nov 2024
Smolle MA Keintzel M Staats K Böhler C Windhager R Koutp A Leithner A Donner S Reiner T Renkawitz T Sava M Hirschmann MT Sadoghi P

Aims

This multicentre retrospective observational study’s aims were to investigate whether there are differences in the occurrence of radiolucent lines (RLLs) following total knee arthroplasty (TKA) between the conventional Attune baseplate and its successor, the novel Attune S+, independent from other potentially influencing factors; and whether tibial baseplate design and presence of RLLs are associated with differing risk of revision.

Methods

A total of 780 patients (39% male; median age 70.7 years (IQR 62.0 to 77.2)) underwent cemented TKA using the Attune Knee System) at five centres, and with the latest radiograph available for the evaluation of RLL at between six and 36 months from surgery. Univariate and multivariate logistic regression models were performed to assess associations between patient and implant-associated factors on the presence of tibial and femoral RLLs. Differences in revision risk depending on RLLs and tibial baseplate design were investigated with the log-rank test.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1327 - 1332
1 Nov 2024
Ameztoy Gallego J Diez Sanchez B Vaquero-Picado A Antuña S Barco R

Aims

In patients with a failed radial head arthroplasty (RHA), simple removal of the implant is an option. However, there is little information in the literature about the outcome of this procedure. The aim of this study was to review the mid-term clinical and radiological results, and the rate of complications and removal of the implant, in patients whose initial RHA was undertaken acutely for trauma involving the elbow.

Methods

A total of 11 patients in whom removal of a RHA without reimplantation was undertaken as a revision procedure were reviewed at a mean follow-up of 8.4 years (6 to 11). The range of motion (ROM) and stability of the elbow were recorded. Pain was assessed using a visual analogue scale (VAS). The functional outcome was assessed using the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), and the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH). Radiological examination included the assessment of heterotopic ossification (HO), implant loosening, capitellar erosion, overlengthening, and osteoarthritis. Complications and the rate of further surgery were also recorded.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1284 - 1292
1 Nov 2024
Moroder P Poltaretskyi S Raiss P Denard PJ Werner BC Erickson BJ Griffin JW Metcalfe N Siegert P

Aims

The objective of this study was to compare simulated range of motion (ROM) for reverse total shoulder arthroplasty (rTSA) with and without adjustment for scapulothoracic orientation in a global reference system. We hypothesized that values for simulated ROM in preoperative planning software with and without adjustment for scapulothoracic orientation would be significantly different.

Methods

A statistical shape model of the entire humerus and scapula was fitted into ten shoulder CT scans randomly selected from 162 patients who underwent rTSA. Six shoulder surgeons independently planned a rTSA in each model using prototype development software with the ability to adjust for scapulothoracic orientation, the starting position of the humerus, as well as kinematic planes in a global reference system simulating previously described posture types A, B, and C. ROM with and without posture adjustment was calculated and compared in all movement planes.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1273 - 1283
1 Nov 2024
Mahmud H Wang D Topan-Rat A Bull AMJ Heinrichs CH Reilly P Emery R Amis AA Hansen UN

Aims

The survival of humeral hemiarthroplasties in patients with relatively intact glenoid cartilage could theoretically be extended by minimizing the associated postoperative glenoid erosion. Ceramic has gained attention as an alternative to metal as a material for hemiarthroplasties because of its superior tribological properties. The aim of this study was to assess the in vitro wear performance of ceramic and metal humeral hemiarthroplasties on natural glenoids.

Methods

Intact right cadaveric shoulders from donors aged between 50 and 65 years were assigned to a ceramic group (n = 8, four male cadavers) and a metal group (n = 9, four male cadavers). A dedicated shoulder wear simulator was used to simulate daily activity by replicating the relevant joint motion and loading profiles. During testing, the joint was kept lubricated with diluted calf serum at room temperature. Each test of wear was performed for 500,000 cycles at 1.2 Hz. At intervals of 125,000 cycles, micro-CT scans of each glenoid were taken to characterize and quantify glenoid wear by calculating the change in the thickness of its articular cartilage.


The Bone & Joint Journal
Vol. 106-B, Issue 11 | Pages 1231 - 1239
1 Nov 2024
Tzanetis P Fluit R de Souza K Robertson S Koopman B Verdonschot N

Aims

The surgical target for optimal implant positioning in robotic-assisted total knee arthroplasty remains the subject of ongoing discussion. One of the proposed targets is to recreate the knee’s functional behaviour as per its pre-diseased state. The aim of this study was to optimize implant positioning, starting from mechanical alignment (MA), toward restoring the pre-diseased status, including ligament strain and kinematic patterns, in a patient population.

Methods

We used an active appearance model-based approach to segment the preoperative CT of 21 osteoarthritic patients, which identified the osteophyte-free surfaces and estimated cartilage from the segmented bones; these geometries were used to construct patient-specific musculoskeletal models of the pre-diseased knee. Subsequently, implantations were simulated using the MA method, and a previously developed optimization technique was employed to find the optimal implant position that minimized the root mean square deviation between pre-diseased and postoperative ligament strains and kinematics.


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1165 - 1175
1 Oct 2024
Frost Teilmann J Petersen ET Thillemann TM Hemmingsen CK Olsen Kipp J Falstie-Jensen T Stilling M

Aims. The aim of this study was to evaluate the kinematics of the elbow following increasing length of the radius with implantation of radial head arthroplasties (RHAs) using dynamic radiostereometry (dRSA). Methods. Eight human donor arms were examined by dRSA during motor-controlled flexion and extension of the elbow with the forearm in an unloaded neutral position, and in pronation and supination with and without a 10 N valgus or varus load, respectively. The elbows were examined before and after RHA with stem lengths of anatomical size, + 2 mm, and + 4 mm. The ligaments were maintained intact by using a step-cut lateral humeral epicondylar osteotomy, allowing the RHAs to be repeatedly exchanged. Bone models were obtained from CT scans, and specialized software was used to match these models with the dRSA recordings. The flexion kinematics of the elbow were described using anatomical coordinate systems to define translations and rotations with six degrees of freedom. Results. The greatest kinematic changes in the elbows were seen with the longest, + 4 mm, implant, which imposed a mean joint distraction of 2.8 mm in the radiohumeral joint and of 1.1 mm in the ulnohumeral joint, an increased mean varus angle of up to 2.4° for both the radius and the ulna, a mean shift of the radius of 2.0 mm in the ulnar direction, and a mean shift of the ulna of 1.0 mm posteriorly. Conclusion. The kinematics of the elbow deviated increasingly from those of the native joint with a 2 mm to a 4 mm lengthening of the radius. This confirms the importance of restoring the natural length of the radius when undertaking RHA. Cite this article: Bone Joint J 2024;106-B(10):1165–1175


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1190 - 1196
1 Oct 2024
Gelfer Y McNee AE Harris JD Mavrotas J Deriu L Cashman J Wright J Kothari A

Aims

The aim of this study was to gain a consensus for best practice of the assessment and management of children with idiopathic toe walking (ITW) in order to provide a benchmark for practitioners and guide the best consistent care.

Methods

An established Delphi approach with predetermined steps and degree of agreement based on a standardized protocol was used to determine consensus. The steering group members and Delphi survey participants included members from the British Society of Children’s Orthopaedic Surgery (BSCOS) and the Association of Paediatric Chartered Physiotherapists (APCP). The statements included definition, assessment, treatment indications, nonoperative and operative interventions, and outcomes. Descriptive statistics were used for analysis of the Delphi survey results. The AGREE checklist was followed for reporting the results.


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1044 - 1049
1 Oct 2024
Abelleyra Lastoria DA Ogbolu C Olatigbe O Beni R Iftikhar A Hing CB

Aims

To determine whether obesity and malnutrition have a synergistic effect on outcomes from skeletal trauma or elective orthopaedic surgery.

Methods

Electronic databases including MEDLINE, Global Health, Embase, Web of Science, ScienceDirect, and PEDRo were searched up to 14 April 2024, as well as conference proceedings and the reference lists of included studies. Studies were appraised using tools according to study design, including the Oxford Levels of Evidence, the Institute of Health Economics case series quality appraisal checklist, and the CLARITY checklist for cohort studies. Studies were eligible if they reported the effects of combined malnutrition and obesity on outcomes from skeletal trauma or elective orthopaedic surgery.


The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1158 - 1164
1 Oct 2024
Jakobi T Krieg I Gramlich Y Sauter M Schnetz M Hoffmann R Klug A

Aims. The aim of this study was to evaluate the outcome of complex radial head fractures at mid-term follow-up, and determine whether open reduction and internal fixation (ORIF) or radial head arthroplasty (RHA) should be recommended for surgical treatment. Methods. Patients who underwent surgery for complex radial head fractures (Mason type III, ≥ three fragments) were divided into two groups (ORIF and RHA) and propensity score matching was used to individually match patients based on patient characteristics. Ultimately, 84 patients were included in this study. After a mean follow-up of 4.1 years (2.0 to 9.5), patients were invited for clinical and radiological assessment. The Mayo Elbow Performance Score (MEPS), Oxford Elbow Score (OES), and Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire score were evaluated. Results. Patients treated with ORIF showed significantly better postoperative range of motion for flexion and extension (121.1° (SD 16.4°) vs 108.1° (SD 25.8°); p = 0.018). Postoperative functional scores also showed significantly better results in the ORIF group (MEPS 90.1 (SD 13.6) vs 78 (SD 20.5); p = 0.004). There was no significant difference between the groups in terms of the complication rate (RHA 23.8% (n = 10) vs ORIF 26.2% (n = 11)). Implant-related complications occurred in six cases (14.3%) in the RHA group and in five cases (11.9%) in the ORIF group. Conclusion. Irrespective of the patient’s age, sex, type of injury, or number of fracture fragments, ORIF of the radial head should be attempted initially, if a stable reconstruction can be achieved, as it seems to provide a superior postoperative outcome for the patient compared to primary RHA. If reconstruction is not feasible, RHA is still a viable alternative. In the surgical treatment of complex radial head fractures, reconstruction shows superior postoperative outcomes compared to RHA. Good postoperative results can be achieved even after failed reconstruction and conversion to secondary RHA. Therefore, we encourage surgeons to favour reconstruction of complex radial head fractures, regardless of injury type or number of fragments, as long as a stable fixation can be achieved. Cite this article: Bone Joint J 2024;106-B(10):1158–1164


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 970 - 977
1 Sep 2024
De Rus Aznar I Ávila Lafuente JL Hachem A Díaz Heredia J Kany J Elhassan B Ruiz Ibán MÁ

Rotator cuff pathology is the main cause of shoulder pain and dysfunction in older adults. When a rotator cuff tear involves the subscapularis tendon, the symptoms are usually more severe and the prognosis after surgery must be guarded. Isolated subscapularis tears represent 18% of all rotator cuff tears and arthroscopic repair is a good alternative primary treatment. However, when the tendon is deemed irreparable, tendon transfers are the only option for younger or high-functioning patients. The aim of this review is to describe the indications, biomechanical principles, and outcomes which have been reported for tendon transfers, which are available for the treatment of irreparable subscapularis tears.

The best tendon to be transferred remains controversial. Pectoralis major transfer was described more than 30 years ago to treat patients with failed surgery for instability of the shoulder. It has subsequently been used extensively to manage irreparable subscapularis tendon tears in many clinical settings. Although pectoralis major reproduces the position and orientation of the subscapularis in the coronal plane, its position in the axial plane – anterior to the rib cage – is clearly different and does not allow it to function as an ideal transfer. Consistent relief of pain and moderate recovery of strength and function have been reported following the use of this transfer. In an attempt to improve on these results, latissimus dorsi tendon transfer was proposed as an alternative and the technique has evolved from an open to an arthroscopic procedure. Satisfactory relief of pain and improvements in functional shoulder scores have recently been reported following its use. Both pectoralis minor and upper trapezius transfers have also been used in these patients, but the outcomes that have been reported do not support their widespread use.

Cite this article: Bone Joint J 2024;106-B(9):970–977.


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 957 - 963
1 Sep 2024
Baek CH Kim JG Kim BT

Aims

Favourable short-term outcomes have been reported following latissimus dorsi tendon transfer for patients with an irreparable subscapularis (SSC) tendon tear. The aim of this study was to investigate the long-term outcomes of this transfer in these patients.

Methods

This was a retrospective study involving 30 patients with an irreparable SSC tear and those with a SSC tear combined with a reparable supraspinatus tear, who underwent a latissimus dorsi tendon transfer. Clinical scores and active range of motion (aROM), SSC-specific physical examination and the rate of return to work were assessed. Radiological assessment included recording the acromiohumeral distance (AHD), the Hamada grade of cuff tear arthropathy and the integrity of the transferred tendon. Statistical analysis compared preoperative, short-term (two years), and final follow-up at a mean of 8.7 years (7 to 10).


The Bone & Joint Journal
Vol. 106-B, Issue 9 | Pages 916 - 923
1 Sep 2024
Fricka KB Wilson EJ Strait AV Ho H Hopper, Jr RH Hamilton WG Sershon RA

Aims

The optimal bearing surface design for medial unicompartmental knee arthroplasty (UKA) remains controversial. The aim of this study was to compare outcomes of fixed-bearing (FB) and mobile-bearing (MB) UKAs from a single high-volume institution.

Methods

Prospectively collected data were reviewed for all primary cemented medial UKAs performed by seven surgeons from January 2006 to December 2022. A total of 2,999 UKAs were identified, including 2,315 FB and 684 MB cases. The primary outcome measure was implant survival. Secondary outcomes included 90-day and cumulative complications, reoperations, component revisions, conversion arthroplasties, range of motion, and patient-reported outcome measures. Overall mean age at surgery was 65.7 years (32.9 to 94.3), 53.1% (1,593/2,999) of UKAs were implanted in female patients, and demographics between groups were similar (p > 0.05). The mean follow-up for all UKAs was 3.7 years (0.0 to 15.6).


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.