Clinical trial NCT03678948: Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Official title: Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Articular Cartilage Disorder of Knee
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Smith & Nephew, Inc.
First posted: 2018-09-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale
timeFrame: change from baseline at week 52 post-op
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: change from baseline at week 52 post-op
measure: International Knee Documentation Committee (IKDC) subjective knee evaluation
timeFrame: change from baseline at week 52 post-op
measure: International Knee Documentation Committee (IKDC) objective knee
timeFrame: change from baseline at week 52 post-op
measure: Marx Activity Rating Scale (MARS)
timeFrame: change from baseline at week 52 post-op
measure: Work Productivity and Activity Impairment (WPAI V2.0)
timeFrame: change from 1 week post op to 6 weeks post-op
measure: MRI
timeFrame: change from baseline at week 52 post-op
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
state: Ohio
Study officials:
affiliation: Ohio State University
name: Christopher Kaeding, M.D.
role: PRINCIPAL_INVESTIGATOR
References: