Expired Study
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Columbus, Ohio 43202


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03678948


Primary Contact:

Principal Investigator
Christopher Kaeding, M.D.
Ohio State University

Courtney K Wright
Phone: 614-293-2410
Email: Courtney.Wright@osumc.edu


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43202
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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