None listed
Conditions
Brief summary
This study aims to compare the outcomes of two different ways of treating cartilage injuries in the ankle. The different techniques are known as a) microfracture and b) micro-fracture with JointRep. The current best surgical practice is to use the microfracture, however, a new technique, which uses JointRep, a specific type of gel, may offer potentially a more favorable outcome. In small cartilage injuries of the ankle that require surgery, the affected area is smoothed out, and then the bone is punctured. These puncture holes cause a small amount of bleeding. This blood forms a clot, from which chemicals encourage healing and formation of new tissue to fill the injured area of cartilage. JointRep is an injectable gel which can be applied during the same surgery. This has been shown to stabilize the clot. This may allow a more concentrated delivery of the healing factors from the blood. participants will be randomized to either procedure. Following surgery, all participants will have the same follow up in orthopaedic outpatient clinics along with regular physiotherapy sessions. at each follow up clinic patients may be asked to complete a survey questionnaire about their recovery and function. Alternatively, study follow up questionnaires (6 and 12 weeks, 6 and 12 months, 2 and 5 years) may also be collected via a secure online survey link sent via email. Some patients may be required to have an additional MRI scan of their ankle at 12 months following their injury to assess which treatment is showing a greater amount of healing tissue. For other patients participating in this study, they will require no additional tests.
Interventions
Microfracture plus Autologous Bio-scaffold Enhanced Chondrogenesis (ABEC)
Randomised intervention patients.
JointRep is a clot stabiliser designed to maintain the pro-chondrogenetic factors released following microfracture in a defect for a longer period.
Each patient will have a diagnostic ankle arthroscopy using medial and lateral portals. Lesion debrided with subsequent creation of stable smooth surrounding articular surface. Microfracture performed with an awl. The subchondral plate is pla
Microfracture plus Autologous Bio-scaffold Enhanced Chondrogenesis (ABEC) Randomised intervention patients. JointRep is a clot stabiliser designed to maintain the pro-chondrogenetic factors released following microfracture in a defect for a longer period. Each patient will have a diagnostic ankle arthroscopy using medial and lateral portals. Lesion debrided with subsequent creation of stable smooth surrounding articular surface. Microfracture performed with an awl. The subchondral plate is plate punctured 3-4mm apart, from the peripheral to the centre of the lesion. Additional procedures performed as required. JointRep to be utilised as per the manufacturer instructions: JointRep prepared during arthroscopy. The defect localised with a 14-gauge needle. The inflow irrigation is stopped, the arthroscope removed but the sleeve is left in. An air circulation is created inside the joint with an inflow sleeve and an outflow suction cannula which is allowed to run for a few minutes. Arthroscope returned to joint. Surgeon injects the desired volume of JointRep™ into the defect under direct visualization. After 2-3 minutes of immobilisation of the ankle, the joint is then closed. This additional step will take 5 minutes. The microfracture which will be performed in both intervention and control groups is variable, dependent on the complexity of the debridement and requirement for additional procedures, but is likely to be less than 1 hour surgical time. This will occur in the operating theatre of the designed orthopaedic surgeon. It will happen once. The person administrating the intervention will be a trained orthopaedic surgeon or designated registrar.
Sponsors
Capital and Coast District Health Board (CCDHB)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
• Symptomatic osteochondral lesion of the talus where microfracture has been offered, with at least 6 months of non-surgical management, as confirmed on MRI, in patients with skeletally mature ankles, aged 18 to 60 years old. • Able to consent to trial inclusion • Medically fit for surgery
Exclusion criteria
• Lesions too small to be considered for microfracture or a specific contra-indication to microfracture • Declared intolerance or allergy to crustaceans or D-glucosamine • Bipolar lesions (kissing lesions of the tibial plafond and talus) • Diffuse arthritic changes • Previous ankle operation • Pregnancy • Neuromuscular disorders • Metabolic arthropathy • Active infection • Self-funded surgery
Outcome results
None listed