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 range18 Years
SexALL
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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
✓. 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
What they're measuring
1
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
. 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)