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

NCT03678948 | Terminated FDA Device

• 1 other identifier: 2018H0244
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Articular Cartilage Disorder of Knee

Outcome Measures

Primary Outcomes (1)

• Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale

  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.

  change from baseline at week 52 post-op

Secondary Outcomes (6)

• Visual Analogue Scale (VAS)

  change from baseline at week 52 post-op

• 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

• Work Productivity and Activity Impairment (WPAI V2.0)

  change from 1 week post op to 6 weeks post-op

Study Arms (2)

Radiofrequency-Based Debridement

ACTIVE COMPARATOR

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.

Device: Radiofrequency-Based Debridement

Mechanical Debridement

ACTIVE COMPARATOR

Device: Mechanical Debridement

Interventions

Radiofrequency-Based Debridement DEVICE

In this process, radiofrequency energy is used to excite the water molecules in a conductive medium, such as an electrolyte (saline) solution, to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds (16-18), excising or dissolving (i.e. ablating) soft tissue at relatively low temperatures (typically 40ºC to 70ºC).

Also known as: Werewolf Coblation Wand

Radiofrequency-Based Debridement

Mechanical Debridement DEVICE

Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement

Mechanical Debridement

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Given written informed consent on the IRB approved consent form specific to the study, prior to study participation
• 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)
• or more chondral lesion(s) as noted on MRI

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Kaeding: lead
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute

Columbus, Ohio, 43202, United States

Location

Study Officials

• Christopher Kaeding, M.D.

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study subject will not be made aware of the treatment received until after completion of the research study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor - Clinical

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 20, 2018
• Study Start: November 8, 2018
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: September 30, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)