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.

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.

Surgical repair of symptomatic chronic achilles tendon rupture using synthetic graft augmentation.

BACKGROUND: Surgical repair of symptomatic chronic Achilles tendon (TA) rupture is a challenging problem due to the presence of a large defect between tendon edges. We report the results of surgical repair of symptomatic chronic TA rupture by synthetic graft augmentation. METHODS: Seven consecutive patients with a symptomatic chronic TA rupture underwent surgical repair by VY plasty and augmentation with bio-absorbable synthetic graft (Artelon®). In all patients, the intraoperative tendon gap after debridement was more than 5cm (Myerson Grade 3). The total duration of plaster immobilization was 10 weeks. The complications were recorded prospectively and functional outcome was assessed by AOFAS score and Achilles tendon Total Rupture Score (ATRS). RESULTS: At a mean follow up of 29 months there was no re-rupture or deep infection. All patients reported good functional outcome as shown by AOFAS and ATRS scores. There were no graft related complications. At final follow up, six patients were able to do single stance heel raise however, calf wasting was noted in all patients. CONCLUSIONS: Tendon repair augmented by absorbable synthetic graft is an acceptable technique in Myerson Grade 3 chronic symptomatic TA ruptures. LEVEL OF EVIDENCE: Level IV, Case series.

Effectiveness of the reverse camber shoe in postoperative hallux valgus surgery.

The reverse camber shoe (RCS) is commonly used for forefoot off-loading during mobilization after forefoot surgery. However, patient satisfaction and compliance may be affected because of the altered gait pattern that is conferred. The aim of this study was to investigate the patient-related factors associated with the compliance in the use of this device. The authors retrospectively reviewed a single surgeon series of 64 patients who underwent forefoot surgery and who were subsequently rehabilitated with early mobilization using the RCS. Data on patient age, arthritic comorbidities, adaptation to device, and symptoms during use were collected via a standardized postal questionnaire. In all, 39 patients complied with the use of the RCS for 8 weeks (group A), whereas 11 patients managed it for less than 6 weeks (group C). Also, 14 patients used the shoe for more than 6 weeks but less than 8 weeks (group B). The authors found that compliance in the use of the RCS is lower in older patients following forefoot surgery. This may be related to poor adaptation in the presence of preexisting arthritis.

The flip test: a reappraisal.

STUDY DESIGN: Diagnostic study. OBJECTIVE: To assess the construct validity of the flip test as a sign of nerve root tension. SUMMARY OF BACKGROUND DATA: The flip test is commonly performed in patients with sciatica to confirm or otherwise nerve root tension evidenced by a restricted supine straight leg raise (SLR). Passive extension of the knee with the patient in the erect position and the hip flexed is reported to cause a sudden falling or flipping back of the trunk. Although widely known there are no research articles validating this test. METHODS: Sixty-seven patients with sciatica and magnetic resonance imaging scans confirming disc protrusion and nerve root compression underwent the flip test. The response of the patient was recorded, compared with the supine SLR, and subjected to statistical analysis. RESULTS: Thirty-three percent of patients felt no pain, 39% felt pain on full extension of the knee, and 28% resisted full extension of the knee due to pain. Only one-third of patients demonstrated a "flip." The response was related to the supine SLR, such that patients with high SLRs tended not to show a painful reaction whereas all patients with a supine SLR below 45 degrees showed a painful response. CONCLUSION: We consider that the flip test has been substantially misinterpreted in the past. However, it remains a useful check of nerve root tension but only for patients with supine SLRs below 45 degrees . The most reliable response was not a flip but the demonstration of pain on extension of the knee. We would recommend the term "sitting SLR test," as a more accurate and less misleading name.

Analysis of stress distribution in lumbar interbody fusion.

STUDY DESIGN: A 2-dimensional axisymmetric finite element model of an intervertebral segment was used to investigate the stress patterns in the adjacent vertebrae of fused spinal segment incorporating 4 common cage designs. The same was used to study the effect of maturation of bone graft on stress distribution pattern. OBJECTIVES: To study and compare the stress distribution patterns in a normal spinal segment and in the adjacent vertebrae of a fused spinal segment. The effect of bone graft incorporation around the mesh cage was also investigated. SUMMARY OF BACKGROUND DATA: Lumbar fusion surgery is thought to relieve discogenic low back pain by eliminating the abnormal intersegmental movement at the level of disc degeneration. Successful spinal fusion does not guarantee symptomatic pain relief. Discogenic pain is also known to be associated with an abnormal load transmission pattern across the degenerate disc. We hypothesized that the lumbar interbody fusion results in relief of discogenic pain by normalizing the load distribution pattern. METHODS: We used a 2-dimensional axisymmetric finite element model of an intervertebral segment to investigate the stress patterns in the vertebrae adjacent to a fused spinal segment incorporating 4 common cage designs: (1) anterior lumbar interbody fusion, (2) posterior lumbar interbody fusion rectangular, (3) posterior lumbar interbody fusion threaded, and (4) mesh cage. RESULTS: High stress concentrations and abnormal overall stress patterns were noted for all the cage designs studied. The anterior lumbar interbody fusion cage with its larger contact area showed the least abnormal stress magnitude in comparison with the other cages. Incorporation of bone in and around the mesh cage increased the area of contact and decreased the abnormal high stresses. The spine fusion model representing final bony healing showed restoration of near physiologic stress pattern. CONCLUSIONS: Interbody fusion cages with larger area of contact between cage and vertebral endplate produces a lower stress distribution pattern. A successful bony fusion restores near physiologic stress distribution pattern. Restoration of near normal load distribution pattern may become an important aim of surgery for discogenic low back pain.

Vascular injuries in total hip replacement arthroplasty: a review of the problem.

Considering the proximity of the major endopelvic and exopelvic vascular structures to the hip joint, we find that reported vascular complications of total hip replacement are relatively rare. We encountered 1 case of vascular injury after primary, and 2 cases after revision, total hip arthroplasty. This stimulated us to send a postal survey to the members of the British Hip Society inquiring about such vascular complications, with a view to evaluating their incidence, management, and final outcome. We received 42 valid replies of 82 questionnaires sent. A conservative estimate from this study is 1 vascular injury in 14 consultant life years of practice. A total of 26 vascular injuries were studied in detail, which included 3 of our index cases. There were 14 cases encountered in revision hip replacement, while the rest occurred in primary hip replacement surgery. Three patterns of presentation of vascular injuries were recognized--immediate, early, and late, all of which require prompt recognition and appropriate treatment. The potential of vascular injury seems to be underestimated in primary total hip replacements, leading to late recognition and poor outcome.