Cost-Utility Analysis of Total Ankle Replacement Compared with Ankle Arthrodesis for Patients Aged 50-85 Years with End-Stage Ankle Osteoarthritis: The TARVA Study.

BACKGROUND: Patients with end-stage ankle osteoarthritis suffer from reduced mobility and quality of life and the main surgical treatments are total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVES: Our aim was to calculate the mean incremental cost per quality-adjusted life-year (QALY) of TAR compared with AF in patients with end-stage ankle osteoarthritis, over 52 weeks and over the patients' lifetime. METHOD: We conducted a cost-utility analysis of 282 participants from 17 UK centres recruited to a randomised controlled trial (TARVA). QALYs were calculated using index values from EQ-5D-5L. Resource use information was collected from case report forms and self-completed questionnaires. Primary analysis was within-trial analysis from the National Health Service (NHS) and Personal Social Services (PSS) perspective, while secondary analyses were within-trial analysis from wider perspective and long-term economic modelling. Adjustments were made for baseline resource use and index values. RESULTS: Total cost at 52 weeks was higher in the TAR group compared with the AF group, from the NHS and PSS perspective (mean adjusted difference £2539, 95% confidence interval [CI] £1142, £3897). The difference became very small from the wider perspective (£155, 95% CI -  £1947, £2331). There was no significant difference between TAR and AF in terms of QALYs (mean adjusted difference 0.02, 95% CI -  0.015, 0.05) at 52 weeks post-operation. The incremental cost-effectiveness ratio (ICER) was £131,999 per QALY gained 52 weeks post-operation. Long-term economic modelling resulted in an ICER of £4200 per QALY gained, and there is a 69% probability of TAR being cost effective at a cost-effectiveness threshold of £20,000 per QALY gained. CONCLUSION: TAR does not appear to be cost effective over AF 52 weeks post-operation. A decision model suggests that TAR can be cost effective over the patients' lifetime but there is a need for longer-term prospectively collected data. Clinical trial registration ISRCTN60672307 and ClinicalTrials.gov NCT02128555.

Outcomes in Ankle Replacement Study (OARS).

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. Results: Data from 238 patients were analyzed. There were significant improvements in MOXFQ and EQ-5D-5L among people who underwent TAA at six- and 12-month assessments compared with preoperative scores (p < 0.001). Most improvement occurred between preoperative and six months, with little further improvement at 12 months. A greater improvement in MOXFQ outcome postoperatively was associated with older age and more advanced radiological signs of ankle osteoarthritis at baseline. Conclusion: TAA significantly benefits patients with end-stage ankle disease. The lack of substantial further overall change between six and 12 months suggests that capturing PROMs at six months is sufficient to assess the success of the procedure. Older patients and those with advanced radiological disease had the greater gains. These outcome predictors can be used to counsel younger patients and those with earlier ankle disease on the expectations of TAA.

Total Ankle Replacement Versus Arthrodesis for End-Stage Ankle Osteoarthritis: A Randomized Controlled Trial.

BACKGROUND: End-stage ankle osteoarthritis causes severe pain and disability. There are no randomized trials comparing the 2 main surgical treatments: total ankle replacement (TAR) and ankle fusion (AF). OBJECTIVE: To determine which treatment is superior in terms of clinical scores and adverse events. DESIGN: A multicenter, parallel-group, open-label randomized trial. (ISRCTN registry number: 60672307). SETTING: 17 National Health Service trusts across the United Kingdom. PATIENTS: Patients with end-stage ankle osteoarthritis, aged 50 to 85 years, and suitable for either procedure. INTERVENTION: Patients were randomly assigned to TAR or AF surgical treatment. MEASUREMENTS: The primary outcome was change in Manchester-Oxford Foot Questionnaire walking/standing (MOXFQ-W/S) domain scores between baseline and 52 weeks after surgery. No blinding was possible. RESULTS: Between 6 March 2015 and 10 January 2019, a total of 303 patients were randomly assigned; mean age was 68 years, and 71% were men. Twenty-one patients withdrew before surgery, and 281 clinical scores were analyzed. At 52 weeks, the mean MOXFQ-W/S scores improved for both groups. The adjusted difference in the change in MOXFQ-W/S scores from baseline was -5.6 (95% CI, -12.5 to 1.4), showing that TAR improved more than AF, but the difference was not considered clinically or statistically significant. The number of adverse events was similar between groups (109 vs. 104), but there were more wound healing issues in the TAR group and more thromboembolic events and nonunion in the AF group. The symptomatic nonunion rate for AF was 7%. A post hoc analysis suggested superiority of fixed-bearing TAR over AF (-11.1 [CI, -19.3 to -2.9]). LIMITATION: Only 52-week data; pragmatic design creates heterogeneity of implants and surgical techniques. CONCLUSION: Both TAR and AF improve MOXFQ-W/S and had similar clinical scores and number of harms. Total ankle replacement had greater wound healing complications and nerve injuries, whereas AF had greater thromboembolism and nonunion, with a symptomatic nonunion rate of 7%. PRIMARY FUNDING SOURCE: National Institute for Health and Care Research Heath Technology Assessment Programme.

The reliability of radiographic measures of total ankle replacement position: an analysis from the OARS cohort.

OBJECTIVE: There is no validated radiographic measurement to diagnose prosthetic complication(s) following total ankle replacements (TARs) although a number of angular and linear measurements, used to define the TAR position on postoperative radiographs, have been recommended to detect prosthetic loosening. The aim of this study was to test the intra- and interobserver reliability of these measurements. MATERIALS AND METHODS: This is a prospective study embedded within a multicentre cohort study. Following sample size calculation, 62 patients were analysed. Six measurements were performed on the first postoperative anteroposterior and lateral ankle radiographs: angles α and ß, and length "a" defined the craniocaudal position of the tibial component, while angle γ, and lengths "b" and "c" defined the angular position of the talar component. Measurements were recorded by three independent observers. Inter- and intraobserver reliability was assessed with intraclass correlation coefficient (ICC), Bland-Altman plots, and within-subject coefficients of variation (CV). RESULTS: The intrarater ICC was "almost perfect" (ICC 0.83-0.97) for all six measurements. The interrater ICC was "substantial" to "almost perfect" (ICC 0.69-0.93). The mean difference in intrarater angular measurements was ≤ 0.6° and ≤ 0.8 mm for linear measurements, and ≤ 2.2° and ≤ 2.1 mm for interrater measurements. Maximum CV for the interrater linear measurements (≤ 17.7%) more than doubled that of the angular measurements (≤ 8.0%). The maximum width of the 95% limits of agreement was 6.5° and 8.4 mm for intrarater measures, and 8.9° and 10.6 mm for interrater measurements. CONCLUSION: Angular measures are more reliable than linear measures and have potential in routine clinical practice for TAR position assessment.

Diabetes: a major risk factor in trauma and orthopaedic surgery.

Diabetes mellitus is a growing epidemic and places a great burden on healthcare services in the UK. Trauma and orthopaedic surgeons find themselves dealing with patients with diabetes on an increasingly regular basis. Any level of surgical trauma can lead to a physiological stress response involving the hypothalamic-pituitary-adrenal axis. The resultant hormone releases can have negative effects on glucose homeostasis. General risks of operating on patients with diabetes include endothelial dysfunction, postoperative sepsis, impaired wound healing and cerebral ischaemia. Polytrauma patients with diabetes have a significantly greater risk of mortality than patients who do not have diabetes. Non-union of fractures is more common in patients with diabetes, as are deep-seated postoperative infections. National guidelines from the Joint British Diabetes Societies for Inpatient Care advise how to manage patients with diabetes in the perioperative period. Trauma and orthopaedic surgeons must be aware of these increased risks of operating and ensure that patients are involved in surgical decision making.

Closing the gap on Achilles tendon rupture: A cadaveric study quantifying the tendon apposition achieved with commonly used immobilisation practices.

The relative benefits of surgical and conservative treatment of Achilles tendon rupture are widely debated. With modern conservative management protocols, the re-rupture risk appears to fall to one similar to surgical repair with negligible loss of function. Conservative management typically employs a period of time in an equinus cast with sequential ankle dorsiflexion in a functional orthosis. The optimal duration of immobilisation and rate of dorsiflexion is unknown. We aimed to quantify the change in Achilles tendon approximation achieved in common immobilisation techniques to assist the design of rehabilitation protocols. Twelve fresh-frozen cadaveric specimens had 2.5cm of Achilles tendon excised. The gap between the tendon ends were measured via windowed full equinus casts and compared with functional boots with successively removed heel wedges. The greatest tendon apposition was achieved with the equinus cast. Each wedge removed decreased the reapproximation by approximately 5mm. This paper supports the early use of maximal equinus casting in early management of acute Achilles tendon ruptures.

A comparative prospective cohort health economic analysis comparing ankle fusion, isolated great toe fusion and hallux valgus surgery.

BACKGROUND: This study assessed the health economics and outcomes of three common foot and ankle operations. METHODS: Between July 2013 and October 2014 all patients undergoing ankle fusion (AF) for osteoarthritis, first metatarsophalangeal joint fusion for osteoarthritis (MF) or hallux valgus surgery (HV) were included. Patients having additional procedures were excluded. Patients completed the Manchester-Oxford Foot Questionnaire (MOX-FQ), the EuroQol EQ-5D-5L questionnaire and the EQ-VAS on presentation and at least 6 months post-operatively. RESULTS: 63 patients undergoing AF (n=22), MF (n=22), or HV (n=32) completed preoperative and postoperative questionnaires. 76 completed preoperative questionnaires and 63 completed the follow up questionnaires. The follow up questionnaires were completed at a median of 12 months (range 6-24 months) following surgery. The mean age at surgery was 59 years (range 26-85 years). Pre-operative MOX-FQ and EQ-5D-5L scores differed significantly between the three groups with AF and MF patients reporting worse scores compared to HV patients. MOX-FQ and EQ-5D-5L significantly improved in all groups from pre-operative levels. MOX-FQ: AF from 53.8 (CI 56.8-50.8) to 22.9 (CI 30.9-14.9), MF from 43.0 (CI 46.4-39.6) to 12.1 (CI 18.3-5.9), HV from 35.4 (CI 39.0-31.7) to 15.6 (CI 21.1-10.1). EQ-5D-5L: AF from 0.30 (CI 0.43-0.17) to 0.66 (CI 0.77-0.55), MF from 0.45(CI 0.52-0.38) to 0.83 (CI 0.90-0.76), HV from 0.71(CI 0.74-0.68) to 0.82 (CI 0.88-0.76). There was no significant difference in the EQ-VAS suggesting it may not be representative of foot and ankle health. Health economics analysis using the EQ-5D-5L data to estimate quality-adjusted life years (QALYs) suggested all three procedures were favourable compared to threshold levels of cost-effectiveness. There were differences in estimated costs between the three operations with AF at £2950 (threshold cost <£5400) and MF at £1197 (threshold cost <£5780) and HV varying from £625 to £1688 (threshold cost <£1640). CONCLUSIONS: This study reveals that the joint-specific (MOX-FQ) and generic health (EQ-5D-5L) outcome scores of patients improved after AF, MF and HV. The greatest benefit from surgery was gained in the arthritic patient groups. In the future, the use of large population patient reported outcome measures data may also potentially have implications for prioritisation of healthcare provision, acting as an indicator of foot and ankle surgical procedures that produce the most benefit to patients.

Radiological assessment of ankle syndesmotic reduction.

INTRODUCTION: The intraoperative assessment of adequacy of syndesmotic reduction is challenging. The aim of this study was to develop a radiographic measure based on the lateral ankle view to assess both the normal and abnormal relationship between the tibia and fibula after simulated syndesmotic malreduction and to evaluate the effect on commonly used mortise measurements. METHODS: Mortise and talar dome lateral radiographs were obtained in eight fresh-frozen cadaveric specimens before and following syndesmosis division and posterior fibular displacement of 2mm increments. Using the technique described, on the lateral radiograph the anterior fibular line ratio (AFL ratio) and posterior fibular line distance (PFL distance) were measured. Both measures were based on the anterior and posterior distal tibia articular margins and flat borders of the fibula. RESULTS: Inter- and intraobserver reliability of the AFL ratio and PFL distance measured almost perfect agreement. In all uninjured specimens the AFL lay just anterior to the midpoint of the tibia and the PFL intersected the posterior tibia articular margin or lay just anterior to it, not posterior. At 2, 4 and 6mm of posterior fibular displacement the decrease in AFL ratio and PFL distance showed significant differences between all pairwise comparisons. CONCLUSION: The proposed new measures of syndesmotic reduction are reproducible and capable of detecting from 2mm of sagittal fibula displacement and can be useful adjuncts in the assessment of syndesmotic reduction.

Functional outcome following an ankle or subtalar arthrodesis in adults.

Arthrodesis surgery aims to give pain relief by abolishing the movement of the joint concerned. Few studies describe the outcome as appreciated by the patient. This was the major concern of the authors, when they set up this retrospective study about the outcome after ankle fusion or subtalar fusion. Inclusion criteria were: pre-existing idiopathic and posttraumatic osteoarthritis, leading to joint pain unresponsive to conservative treatment, clinically and radiologically fused with an open approach between 2007 and 2011. Exclusion criteria were: preexisting joint infection, diabetes, rheumatoid arthritis, nonunion, age below 18 years, decease, and arthroscopic fusion. Fifteen ankle fusions and 18 subtalar fusions fulfilled the criteria. The mean age of the patients was 77 and 69 years, respectively; the average follow-up period was 3 and 4 years. A telephone questionnaire showed that the average patients' satisfaction was 7.86/10 in the ankle group and 7.94/10 in the subtalar group. All patients driving a car prior to surgery were able to do so afterwards. Forty percent walked unaided and without problems (excellent). Fifty-one percent were able to mobilise, but their walking distance was limited and a stick was required (good or fair). Nine percent were unable to mobilise out of their homes (poor), however it was generalized osteoarthritis which limited their mobility. Forty-five percent were involved in sports including judo, swimming, cycling, jogging, gardening, bowling, golf, and boules.

The rheumatoid foot and ankle: current evidence.

The management of rheumatoid patients is a complex process due to the chronic, systemic, multi-joint and extra-articular nature of the disease. In comparison, osteoarthritis and post-traumatic arthritis usually involve a single joint and are hence not comparable to rheumatoid pathology. This review sets out to specifically look at studies on rheumatoid patients with interventions for foot or ankle disease. MEDLINE, EMBASE, the Cochrane databases, Current Controlled Trials and the WHO International Clinical Trials Registry Platform are all searched for relevant studies.

Interventions for treating osteochondral defects of the talus in adults.

BACKGROUND: Osteochondral defects of the talus are usually a consequence of trauma. They can cause chronic pain and serious disability. Various interventions, non-surgical and surgical, have been used for treating these defects. OBJECTIVES: The objective of this review is to determine the benefits and harms of the interventions used for treating osteochondral defects of the talus in adults. SEARCH STRATEGY: We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, MEDLINE In-Process, EMBASE, Current Controlled Trials, the WHO International Clinical Trials Registry Platform and reference lists of articles. Date of last search: December 2009. SELECTION CRITERIA: Eligible for inclusion were any randomised or quasi-randomised controlled clinical trials evaluating interventions for treating osteochondral defects of the talus in adults. Our primary outcomes included pain, ankle function, treatment failure (unresolved symptoms or reoperation) and health-related quality of life. Preference was given to validated, patient-reported outcome measures. DATA COLLECTION AND ANALYSIS: Two review authors independently evaluated trials for inclusion and, for the included trial, independently assessed the risk of bias and extracted data. MAIN RESULTS: One small trial with 15 participants and six months follow-up was included. This trial was published only as a conference abstract, which provided inadequate information to judge the trial's methods and no numerical results. The trial reported that a series of three intra-articular hyaluronan injections started three weeks after arthroscopic microfracture did not to improve pain but may have improved one aspect of mobility. There were no available data to check this claim. AUTHORS' CONCLUSIONS: There is insufficient evidence from randomised trials to determine which interventions are best for osteochondral defects of the talus in adults. High quality randomised trials are required to guide non-surgical and surgical treatment decisions for these injuries.

Lisfranc injuries.

lisfranc injuries are fracture-dislocations of the torsometatarsal joint. They are usually associated with high energy trauma and are regularly overlooked. An early diagnosis and urgent orthopaedic referral is required to minimize the long-term consequences.