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 range
40 Years
Sex
ALL
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 \[e.g. diabetes pump\])
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire scores