None listed
Conditions
Brief summary
The study is a prospective investigation analyzing the outcomes of patients with unicompartmental osteoarthritis undergoing osteotomy (HTO). We will compare the outcomes of patients undergoing HTO alone, to those undergoing the combined procedure of HTO and MACI resurfacing of the arthritic femoral and tibial surfaces of the involved compartment. It has been shown previously that some articular surface regeneration can occur with HTO alone, although the amount and quality of this regenerate is not well defined. The next stage in evolution of regeneration would seem to be to directly promote this by chondrocyte transplantation. Techniques such as MACI have successfully improved patient outcomes in the treatment of isolated chondral defects. The next step would be to show these improvements are possible in patients with more advanced osteoarthritis. Before advocating this however, it is important to show objective advantages of this technique over HTO alone. The outcomes will be assessed radiologically and clinically, and if the combined procedure is shown to have superior results, this would provide greater evidence for increased application of this technology. In addition, this would demonstrate a clear advantage of the MACI technique over periosteal patch techniques due to the difficulty of application of periosteal patches to diffuse arthritic defects.
Interventions
High Tibial Osteotomy (HTO) is a well established operation for osteoarthritis. The principle of this surgery is as follows: in patients with arthritis localised to one side of their joint (usually the medial side) and a corresponding alignment that places the majority of their weight in this area, correcting the alignment to place the body weight towards the other side of the joint will usually relieve symptoms as well as slow the progression of the arthritis. The damaged articular cartilage is
High Tibial Osteotomy (HTO) is a well established operation for osteoarthritis. The principle of this surgery is as follows: in patients with arthritis localised to one side of their joint (usually the medial side) and a corresponding alignment that places the majority of their weight in this area, correcting the alignment to place the body weight towards the other side of the joint will usually relieve symptoms as well as slow the progression of the arthritis. The damaged articular cartilage is thought to then have some potential also to repair or regenerate. Another option is to combine this procedure with another well established technique of articular cartilage transplantation (MACI) to restore the joint surface in the arthritic side of the knee joint. The purpose of this study is to compare the clinical and Magnetic Resonance Imaging (MRI) results of patients who simply have an HTO alone, with those who have an HTO combined with MACI, to determine whether or not addition of this new technique enhances the regeneration and repair of damaged cartilage in knee joints with arthritis. This will have significant implications for our ability to treat arthritis and return arthritic joints back to normal function.
Sponsors
Sydney Orthopaedic Research Institute
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to -2147483648 N/A
Healthy volunteers
No
Inclusion criteria
Inclusion will involve those patients who have been placed on waiting list for high tibial osteotomy. The patients will be offered the opportunity to take part in the trial, with no consequences for early withdrawal.
Exclusion criteria
Patients will be excluded, or removed from the study due to severe claustrophobia in MRI scanner, Gadolinium sensitivity or patients’ withdrawal.
Outcome results
None listed