Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions

Not Applicable

Terminated

• Conditions: Articular Cartilage Disorder of Knee
• Interventions: Device: Mechanical Debridement; Device: Radiofrequency-Based Debridement

• Registration Number: NCT03678948
• Lead Sponsor: Christopher Kaeding

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.

Study Timeline

• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-09-18
• Study First Posted: 2018-09-20
• Study Start: 2018-11-08
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-24
• Last Update Posted: 2021-09-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mechanical Debridement	Mechanical Debridement	-
Radiofrequency-Based Debridement	Radiofrequency-Based Debridement	The Smith and Nephew WEREWOLF COBLATION System is indicated for all soft tissue types in the knee. The WEREWOLF COBLATION System is a FDA cleared bipolar, radiofrequency electrosurgical system designed for use in orthopaedic/arthroscopic surgical procedures.

Primary Outcome Measures

Name	Time	Method
Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale	change from baseline at week 52 post-op	The previous week is the time period considered when answering the questions. Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale.

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	change from baseline at week 52 post-op	Using a ruler, the score is determined by mea-suring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
International Knee Documentation Committee (IKDC) subjective knee evaluation	change from baseline at week 52 post-op
International Knee Documentation Committee (IKDC) objective knee	change from baseline at week 52 post-op
Marx Activity Rating Scale (MARS)	change from baseline at week 52 post-op	MARS includes 4 items that assess the frequency of running, cutting, decelerating, and pivoting based on the subjects "healthiest and most active state in the past year." A higher score indicates more functional demand on the knee joint and potentially a higher risk of injury. Each item is scored on a 5-point ordinal scale ranging from 0 (less than 1 time in a month) to 4 (4 or more times in a week), and the total scale score is obtained by summing the individual items' scores (range, 0-16).
Work Productivity and Activity Impairment (WPAI V2.0)	change from 1 week post op to 6 weeks post-op	Asks about the effect of patient knee injury on their ability to work and perform normal daily activities
MRI	change from baseline at week 52 post-op	Baseline MRI will be compared to MRI at 52 weeks to evaluate knee morphology, cartilage signal, osteophytes, bone marrow edema, subarticular cysts, effusions and loose bodies. The international cartilage repair score will be used.

Trial Locations

Locations (1)

The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute; 🇺🇸 Columbus, Ohio, United States