Guy Wansbrough

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus

Background: Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. Methods: In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject’s outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. Results: VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. Conclusion: A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level of Evidence: Level I, prospective randomized study.

Correlation of Hallux Rigidus Grade With Motion, VAS Pain, Intraoperative Cartilage Loss, and Treatment Success for First MTP Joint Arthrodesis and Synthetic Cartilage Implant:

Background: Grading systems are used to assess severity of any condition and as an aid in guiding treatment. This study examined the relationship of baseline motion, pain, and observed intraoperative cartilage loss with hallux rigidus grade. Methods: A prospective, randomized study examining outcomes of arthrodesis compared to synthetic cartilage implant was performed. Patients underwent preoperative clinical examination, radiographic assessment, hallux rigidus grade assignment, and intraoperative assessment of cartilage loss. Visual analog scale (VAS) score for pain was obtained preoperatively and at 24 months. Correlation was made between active peak dorsiflexion, VAS pain, cartilage loss, and hallux rigidus grade. Fisher’s exact test was used to assess grade impact on clinical success (P < .05). Results: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (–0.069, P = .327) or VAS pain (–0.078, P = .271). Rank correlations between grade and cartilage loss were significant, but correlations were small. When stratified by grade, composite success rates between the 2 treatments were nearly identical. Conclusions: Irrespective of the grade, positive outcomes were demonstrated for both fusion and synthetic cartilage implant. Clinical symptoms and signs should be used to guide treatment, rather than a grade consisting of radiographic, symptoms, and range of motion factors. Level of Evidence: Level II, randomized clinical trial.

A comparison of energy consumption between the use of a walking frame, crutches and a Stride-on rehabilitation scooter

BACKGROUND Following foot and ankle surgery, patients may be required to mobilise non-weight bearing, requiring a walking aid such as crutches, walking frame or a Stride-on rehabilitation scooter, which aims to reduce the amount of work required. The energy consumption of mobilising using a Stride-on scooter has not previously been investigated, and we aim to establish this. METHODS Ten healthy volunteers (5 males:5 females) aged 20-40 years mobilised independently, then with each mobility device for 3min at 1km/h on a treadmill, with rest periods, whilst undergoing Cardio-Pulmonary Exercise Testing (CPET). Oxygen consumption (VO2), carbon dioxide excretion (VCO2), minute ventilation (MV), respiratory rate (RR) and pulse (HR) were measured at baseline, and after 3min of walking, without and with all 3 devices. Wilcoxon signed rank test was carried out to calculate significance with non-parametric values with Bonferroni correction. RESULTS Three-point crutch mobilisation demonstrated significant increases in VO2 (0.7L), VCO2 (0.7L), MV (16.7L/min), pulse (24.8bpm) and RR (11.4breaths/min) compared to walking (p<0.05). Mobilisation with a frame produced significant (p<0.05) increases compared to walking; VO2 (0.7L), VCO2 (0.7L), MV (18.3L/min), pulse (35.9bpm), and RR (11.7breaths/min). Tests using the Stride-on demonstrated no significant increase compared to walking with regards to VO2 (0.1L; p=0.959), VCO2 (0.2L; p=0.332), pulse (10.1bpm; p=0.575), and RR (4.7breaths/min; p=0.633). The MV was significantly higher compared to walking (4.3L/min; p<0.05). DISCUSSION Energy required for unit distance ambulation with a Stride-on device is similar to walking, and significantly lower than with a walking frame in single legged stance and three-point crutch mobilisation. This justifies its use as part of routine practice aiding early mobilisation of patients requiring restricted weight bearing or single legged weight bearing, especially in those with reduced cardio-pulmonary reserve as it is less physiologically demanding and does not rely on upper body strength.

Medial Gastrocnemius Flap for Reconstruction of the Extensor Mechanism of the Knee Following High-Energy Trauma. A minimum 5 year follow-up

INTRODUCTION The purpose of this study was to assess the medium-term results of reconstruction of the extensor mechanism using the medial gastrocnemius while also providing soft tissue coverage. MATERIALS AND METHODS This retrospective review consisted of a consecutive series of four patients (age 28-40 years) with complex high energy traumatic injuries to lower extremity including both soft tissue loss and disruption of the knee extensor mechanism. The medial gastrocnemius rotational flap was used to reconstruct the patellar tendon and restore soft tissue coverage simultaneously. Range of motion and extensor lag; functional recovery was judged by return to work and sports activity. Validated measures included the Oxford Knee Score, Knee Injury and Osteoarthritis Outcome Score, and the modified Cincinnati Score. RESULTS At the final follow up was 61.5 (57-66) months after reconstruction, the mean SF 12 physical component score ranged from 21.7 to 56.8 with a median of 55.3; the mental component from 42.8 to 60.7 with a median of 58.6. The KSS knee score ranged from 50 to 78 with a median of 68; the function score from 65 to 90 with a median of 85. The Oxford knee score ranged from 22 to 45 with a median of 33.5. The KOOS ranged from 28 to 82.7 with a median of 73.7 and the modified Cincinnati score from 38 to 82 with a median of 76.5. Knee range of motion ranged from 0 to 120°. Of the four patients three returned to working fulltime in their profession and returned to sports, including mountain biking and fitness training. CONCLUSIONS For severe traumatic knee injuries with the combination of soft tissue defects and disruption of the extensor mechanism, the medial gastrocnemius flap provides an excellent reconstructive option to address both problems simultaneously. The results of this small case series support the use of this limb salvage technique.

Five-year Outcomes of a Synthetic Cartilage Implant for the First Metatarsophalangeal Joint in Advanced Hallux Rigidus

Introduction/Purpose: Hallux rigidus is the most common arthritic condition of the foot. A prospective, randomized, noninferiority clinical trial of first metatarsophalangeal joint (MTPJ) hemiarthroplasty with a synthetic polyvinyl alcohol hydrogel implant, for moderate to severe hallux rigidus, demonstrated maintenance of MTPJ active dorsiflexion motion and excellent pain relief; additionally, the trial showed functional outcomes and safety equivalent to first MTPJ arthrodesis at 24 months (Baumhauer et al. 2016; FAI:37(5):457-469). Recognizing that many hemiarthroplasty and total toe implants have initially good results that deteriorate over time, the purpose of this study was to prospectively assess the safety and efficacy outcomes for the synthetic cartilage implant population and to determine if the excellent outcomes were maintained at >5 years.

Does cutting a plaster window weaken its strength

INTRODUCTION A plaster window is usually created over a pressure area, or in some cases a wound or suture line. This can relieve pressure at the site, and provide an opportunity to change dressings, check on drainage, and inspect a wound or ulcer. There is concern that this can have an effect on its function to provide fracture stability, and weakens the plaster. The biomechanical effects of windowing on plaster strength were therefore investigated, as it has not previously been reported. METHOD A laboratory study was undertaken to compare the bending, kinking and torsion loads withstood by standardised Plaster of Paris (POP), Softcast and Fibreglass casts compared to those with a 60×40mm window fabricated in the centre at clinically defined endpoints using an Instron machine. RESULTS The addition of a window significantly weakened the load to failure of POP; Fibreglass, and Softcast by 23.1% (473.1N); 25.9% (401.8N), and 29% (146.6N) respectively, during the 4-point bending tests. During the 3-point kinking tests, load to failure was reduced by 38.5% (297.8N); 35.3% (146.9N), and 51.5% (103.8N) respectively. All tests were checked for consistency and carried out in a single orthogonal plane for ease of comparison. DISCUSSION The addition of a 60×40mm window to a cast made up of POP, Fibreglass or Softcast weakens the cast load to failure by up to 51% against a 3-point loading force. Though windowing of casts is necessary in certain situations, we advise precautions such as adding further layers of plaster to the window site, keeping the window as small as possible, and advising the patient of the increased risk of weakening and failure of the plaster so that they can take more care.

Treatment of first metatarsophalangeal joint arthritis using hemiarthroplasty with a synthetic cartilage implant or arthrodesis: A comparison of operative and recovery time

BACKGROUND First metatarsophalangeal joint (MTPJ1) hemiarthroplasty using a novel synthetic cartilage implant was as effective and safe as MTPJ1 arthrodesis in a randomized clinical trial. We retrospectively evaluated operative time and recovery period for implant hemiarthroplasty (n=152) and MTPJ1 arthrodesis (n=50). METHODS Perioperative data were assessed for operative and anaesthesia times. Recovery and return to function were prospectively assessed with the Foot and Ankle Ability Measure (FAAM) Sports and Activities of Daily Living (ADL) subscales and SF-36 Physical Functioning (PF) subscore. RESULTS Mean operative time for hemiarthroplasty was 35±12.3min and 58±21.5min for arthrodesis (p<0.001). Anaesthesia duration was 28min shorter with hemiarthroplasty (p<0.001). At weeks 2 and 6 postoperative, hemiarthroplasty patients demonstrated clinically and statistically significantly higher FAAM Sport, FAAM ADL, and SF-36 PF subscores versus arthrodesis patients. CONCLUSION MTPJ1 hemiarthroplasty with a synthetic cartilage implant took less operative time and resulted in faster recovery than arthrodesis. LEVEL OF EVIDENCE III, Retrospective case control study.

2017 Roger A. Mann Award Winner: Correlation of Hallux Rigidus Coughlin Grade with First MTP Motion, Intra-operative Cartilage Loss and Treatment Success for 1st MTP Arthrodesis and Hemi-Arthroplasty

Category: Midfoot/Forefoot Introduction/Purpose: Hallux rigidus (HR) is a very common symptomatic problem affecting one in 40 patients over the age of 50 years. A variety of treatment options exist and, as is common in surgery, grading systems are used to assess severity of the condition and aid in the guidance of treatment. The most commonly used grading system for HR uses radiographic images, great toe range of motion and clinical symptoms. This study examines the relationship of radiographic and motion findings to observed intra-operative cartilage loss in patients with HR and explores hallux rigidus grade and cartilage loss as predictive variables for treatment outcomes. Methods: A prospective, randomized non-inferiority study examining outcomes of arthrodesis compared to hemiarthroplasty of the first metatarsal phalangeal joint (Cartiva®) was performed.2 All randomized and treated patients were included in this study. Patients underwent pre-operative clinical examination, including measures of joint motion, radiographic assessment and HR grade. Operatively, observations of cartilage loss on the metatarsal head and opposing proximal surfaces were recorded. All patients’ data, irrespective of treatment, were aggregated and Spearman Rank Correlation coefficients used to assess for strength of correlation of active peak dorsiflexion and cartilage loss to HR grade. Outcomes data were then separated by treatment group and two-sided Fisher’s Exact test assessed these variables’ impact on clinical success (p<0.05). Results: In 202 patients, 59 (29%), 110 (55%), and 33 (16%) were classified as Coughlin1 Grades 2, 3, and 4, respectively. There was no correlation between grade and active peak dorsiflexion (-0.02, p=0.78). While rank correlations between grade and cartilage loss on the proximal phalanx and metatarsal head statistically significantly differed from zero, the magnitudes of the correlations were small, 0.176 (p=0.01) and 0.224 (p=0.001), respectively (Table 1). Among Grade 4 patients, 36.4% had no metatarsal cartilage remaining; but this was also found in 8.5% of Grade 2 patients. Similarly, 52.5% of Grade 2 patients had ≥50% metatarsal cartilage remaining; but this was also found in 21.2% of Grade 4 patients. None of the observed factors were significantly associated with likelihood of achieving composite success. Conclusion: This study examines the relationship of motion and intra-operative cartilage loss findings with a commonly used clinical and radiographic grading system for hallux rigidus. This study population included only candidates with HR considered a candidate for arthrodesis based on review of clinical symptoms however the Grade assigned maybe Coughlin Grade 2, 3 or 4. Irrespective of the Grade, positive outcomes were demonstrated within both treatment groups. The weak correlations of preoperative motion and intra-operative cartilage loss to grade suggests that clinical symptoms should be a significant determinant guiding the treatment option rather than radiographic or range of motion factors.