None listed
Conditions
Brief summary
This research project seeks to ascertain the impact of differential functional rehabilitation on the short-term outcome of Matrix-Induced Autologous Chondrocyte Implantation (MACI), a surgical technique established for the treatment of articular cartilage defects in the knee. It aims to test the hypothesis that MACI patients who undergo accelerated functional rehabilitation exhibit superior subjective, functional, biomechanical and radiographic outcomes, compared to patients who follow a conservative course of rehabilitation following MACI surgery.
Interventions
This study will provide two differing approaches to post-operative rehabilitation following autologous chondrocyte implantation (ACI), a technique to address articular cartilage defects in the knee.
All patients are enrolled in the rehabilitation program for 12 weeks, and will attend rehabilitation for two sessions per week (1-2 hours duration). These sessions will be fully supervised (one-to-one supervision) by an Accredited Exercise Physiotherapist. Whilst progressive resistance, range of mot
This study will provide two differing approaches to post-operative rehabilitation following autologous chondrocyte implantation (ACI), a technique to address articular cartilage defects in the knee. All patients are enrolled in the rehabilitation program for 12 weeks, and will attend rehabilitation for two sessions per week (1-2 hours duration). These sessions will be fully supervised (one-to-one supervision) by an Accredited Exercise Physiotherapist. Whilst progressive resistance, range of motion and hydrotherapy exercises will be the same for both rehabilitation groups, the gradient and time to full weight bearing (WB) following surgery will differ. The traditionally ‘conservative’ protocol (Group 1) consists of a five week period of WB at 20% (toe-touch) body weight (BW), followed by a progressive increase to full WB at 11 weeks post-surgery. The ‘accelerated’ protocol progressively increases WB immediately with full WB attained at eight weeks post-surgery.
Sponsors
University of Western Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Male or female subjects; Aged between 16-65 years; Localised, full thickness medial or lateral femoral condylar defects (<10cm2 upon MRI evaluation); Trochlear or patella defects, provided they are in conjunction with a primary condylar defect; Chondral or osteochondral lesions; Ligamentous deficiencies, provided they are addressed prior to or at the time of surgery; Acceptance of rehabilitation procedure by subject; Having provided written informed consent.
Exclusion criteria
Multiple defects; Isolated trochlear or patella defects; Presence of ongoing, progressive inflammatory arthritis; Unstable knee joint; Obesity exceeding >35 using the body mass index (BMI); Varus or valgus abnormalities (>+2°; <-5° (tibiofemoral anatomical angle)); Known allergy towards gentamycin or hypersensitivity; Known allergy towards products of bovine or porcine origin; Osteonecrosis; Chondrocalcinosis; Osteoarthritis; Rheumatoid arthritis; Infectious diseases; and Pregnancy.
Outcome results
None listed