RecruitingACTRN12607000505404

A study assessing Periarticular Knee Osteotomy Surgery Outcomes with or without Autologous Chrondrocyte Implantation (MACI technique).

A prospective Controlled Trial assessing Periarticular Knee Osteotomy Surgery Outcomes with or without Autologous Chrondrocyte Implantation (MACI technique).


Sponsor

Sydney Orthopaedic Research Institute

Enrollment

20 participants

Start Date

Sep 30, 2007

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: -2147483648 N/As

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining a type of knee surgery called high tibial osteotomy (HTO) — which realigns the knee to shift weight off the damaged joint — with a cartilage repair technique called MACI (where a patient's own cartilage cells are grown and implanted) gives better results than HTO alone. Both procedures aim to relieve knee pain and improve function in people with osteoarthritis (wear and tear) affecting one side of the knee. Outcomes will be measured with clinical assessments and imaging, including MRI scans. You may be eligible if: - You are 18 years of age or older - You are on the waiting list for high tibial osteotomy - You are willing to take part and understand you can withdraw at any time You may NOT be eligible if: - You have severe claustrophobia that prevents you from having an MRI scan - You have a sensitivity (allergy) to gadolinium (the dye used in some MRI scans) - You choose to withdraw from the study Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 th

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.


Locations(1)

Australia

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