Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
| Status: | Not yet recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 9/22/2018 |
| Start Date: | September 2018 |
| End Date: | December 2020 |
| Contact: | Courtney K Wright |
| Email: | Courtney.Wright@osumc.edu |
| Phone: | 614-293-2410 |
Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
The purpose of this study is to evaluate the changes in clinical and imaging outcomes
following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or
Mechanical Debridement in subjects 18-50 years of age.
following arthroscopic treatment of chondral lesion(s) by Radiofrequency-Based debridement or
Mechanical Debridement in subjects 18-50 years of age.
This is a non-inferiority, prospective, single blinded, randomized, single-center study
design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study).
The sample size of 82 participants was calculated from a power analysis. The study was
powered to detect at least a seven point change in KOOS pain score based on achieving 80%
statistical power to detect a non-inferiority margin. Study duration will be until the last
subject enrolled reaches 52 weeks post-operative.
The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand
treatment group or mechanical debridement treatment group. Subjects will be blinded to their
treatment assignment until they complete all study visits. Upon withdraw from the study,
termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy,
the blinded assignment will be revealed to the subject.
design with enrollment of 82 randomized subjects (to assure 70 subjects complete the study).
The sample size of 82 participants was calculated from a power analysis. The study was
powered to detect at least a seven point change in KOOS pain score based on achieving 80%
statistical power to detect a non-inferiority margin. Study duration will be until the last
subject enrolled reaches 52 weeks post-operative.
The 82 randomized subjects will be randomized at a 1:1 ratio into the Werewolf Coblation wand
treatment group or mechanical debridement treatment group. Subjects will be blinded to their
treatment assignment until they complete all study visits. Upon withdraw from the study,
termination from the study, or new or recurrent symptoms requiring a subsequent arthroscopy,
the blinded assignment will be revealed to the subject.
Inclusion Criteria:
- Given written informed consent on the IRB approved consent form specific to the study,
prior to study participation
- 18-50 years old
- Male or Female
- Suspected chondral damage in the following locations where debridement is indicated:
- Medial femoral condyle
- Lateral femoral condyle
- Trochlea
- Patella
- < 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg)
- 1 or more chondral lesion(s) as noted on MRI
Exclusion Criteria:
- Previous chondral treatment in the same compartment (prior debridement and lavage
performed more than three months prior to baseline are acceptable)
- Focal chondral defect indicated for concomitant procedures (i.e., microfracture, ACI,
MACI, OATs)
- Concomitant procedures that are not allowed:
- Lateral retinacular release
- Excision of osteophytes
- Subchondroplasty
- Manipulation under anesthesia
- ACL reconstruction
- Quad tendon repair
- Patellar tendon repair
- Patellar tendon debridement
- Multiligament reconstruction
- Pregnant and/or intending to become pregnant during this study period
We found this trial at
1
site
Columbus, Ohio 43202
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