Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions (NCT01803880) | Clinical Trial Compass
TerminatedNot Applicable
Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
Stopped: Unable to meet enrollment goals
United States148 participantsStarted 2013-03-08
Plain-language summary
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.
Who can participate
Age range
18 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
. Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
. Is male or non pregnant female ≥ eighteen (18) years of age
. MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
. Must present with pain in the index knee of moderate or severe (\> 30 mm) as measured by the VAS
. Must be able to understand English (written and oral)
. Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations
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 From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
. Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
. Single, treatable chondral lesion, localized to the medial femoral condyle,
Exclusion criteria
. Body Mass Index (BMI) \> 40 or index joint pain is due to BMI (as determined by Investigator)
. Requires bilateral knee surgery
. Any of the following conditions:
. active joint infections
. is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
. inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
. metastatic and/or neoplastic disease
. infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)