Chondral Lesion Plus Partial Medial Meniscectomy Clinical Trial
Official title:
A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
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.
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled,
adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites.
Study duration will be until the last subject enrolled reaches 104 weeks post-operative.
The study will be comprised of two parts:
Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2
Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand.
Investigators must be qualified by training to perform procedures prior to use of either
study device. This purpose of Part I will be to minimize variability with the recommended
directions for use established in the instructions for use (IFU). Part I subjects will be
followed per protocol follow-up requirements, and will be included in the safety population
only. These subjects will be additive (to the safety population) to the 82 randomized
subjects planned as part of the primary evaluation in Part II.
Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate
enrollment of subjects in this part of the study following completion of Part I requirements.
The Part II study implements a randomized adaptive study design, whereby an interim analysis
will be conducted for sample size re-assessment. There is no intention of reducing the sample
size as a result of this interim analysis; however, the sample size may be increased to
either establish the non-inferiority and/or may be increased sufficiently to establish
superiority depending on the results of the interim analysis.
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