Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee (NCT03699046) | Clinical Trial Compass
UnknownNot Applicable
Evaluating the Effectiveness of Subchondroplasty for Treating Bone Marrow Lesions of the Knee
Canada18 participantsStarted 2018-10-18
Plain-language summary
The primary objective of this randomized pilot study is to evaluate whether subchondroplasty combined with knee arthroscopy is more effective at reducing knee pain and improving knee function compared to knee arthroscopy alone. All knee function outcomes will be assessed at initial presentation, 3 months, 6 months, 12 months, and 24 months following surgery using validated questionnaires. Patient-reported pain will also be recorded at 2 weeks after surgery.
The secondary objective of the study is to determine whether the subchondroplasty and knee arthroscopy group has better bone quality and bone micro-architecture compared to the group receiving knee arthroscopy alone. Bone quality/micro-architecture will be evaluated at baseline, 3 months, and 12 months following surgery using Magnetic resonance imaging (MRI) and High-Resolution Peripheral Quantitative CT (HR-pQCT) imaging and at baseline, 3 months, 12 months, and 24 months after surgery using X-rays.
Who can participate
Age range40 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 40 years of age or older
✓. Kellgren-Lawrence grade 1-3 osteoarthritis in the affected knee
✓. Has experienced pain in the affected knee for at least 3 months
✓. Candidate for knee arthroscopy (moderate to severe symptoms, lack of response to non-operative care, and/or mechanical symptoms)
✓. Stable ligament exam
✓. No additional injuries affecting the study knee or contralateral knee
✓. Candidate for MRI (no pacemaker, aneurysmal clip, eye prosthesis, pregnancy, neurostimulator, implanted stimulator \[e.g. diabetes pump\])
✓. Confirmed visualization of at least 1 bone marrow lesions using T2 weighted MRI
Exclusion criteria
✕. Determined to not be a surgical candidate
✕. Kellgren-Lawrence grade 4 osteoarthritis
What they're measuring
1
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores