Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy (NCT00613535) | Clinical Trial Compass
TerminatedPhase 4
Knee Articular Cartilage Debridement in Conjunction With Partial Meniscectomy
Stopped: The correlation coefficient at the interim analysis with results for all three groups pooled, did not reach the level of statistical significance of (p\<0.05).
United States165 participantsStarted 2008-04
Plain-language summary
The aim of this study is to describe changes at the site of the study patient's articular cartilage lesion on the femoral condyle with multiple magnetic resonance imaging (MRI) outcomes 6 months after treatment using one of three standard surgical treatment methods: 1) lavage debridement; 2) mechanical debridement; 3) mechanical and radiofrequency-based debridement.
Who can participate
Age range18 Years – 60 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:Screening
* Age between 18 and 60 years
* BMI \<35
* Meniscal tear (medial or lateral) diagnosed by H+P exam and/or imaging in the index knee
* No severe joint space narrowing (IKDC Classification) seen on weight-bearing AP X-ray in the index knee
* No avascular necrosis in the index knee as evidenced by preop MRI obtained within 6 months prior to randomization
* No Varus (\>10 degrees) or Valgus (\>15 degrees)knee deformities as seen by AP X-ray in the index knee
* Minimal or no abnormality of contralateral knee as shown by clinical exam and/or imaging
* Candidate for unilateral arthroscopic treatment of the knee
* Visual Analog Scale (VAS) pain score of 30 mm or greater in the index knee at the time of screening
* Must be able to undergo MRI at required time points per appendix D
* Physically and mentally willing and able to comply with study requirements
* Must be willing and able to follow the standardized rehabilitation protocol (Appendix C)
* Subject must sign IRB approved informed consent form
Arthroscopy Inclusion Criteria:
* Arthroscopic confirmation of ICRS Grade II or III chondral lesion on the medial or lateral femoral condyle
Exclusion Criteria: Screening
* Knee instability, malalignment, or patellar tracking dysfunction in the index knee
* Inflammatory rheumatoid arthritis or other systemic inflammatory arthritis in the index knee or contralateral knee
* Previous total meniscectomy in the index knee
* Previous surgical treatment of the in…
What they're measuring
1
In vivo magnetic resonance imaging (MRI) features of the femoral condyle chondral lesion