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

NCT ID: NCT03678948

Last Updated: 2021-09-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-08
• Study Completion Date: 2021-02-08

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.

Conditions

Articular Cartilage Disorder of Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Radiofrequency-Based Debridement

Intervention Type: 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).

Mechanical Debridement

Group Type: ACTIVE_COMPARATOR

Mechanical Debridement

Intervention Type: DEVICE

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

Interventions

Radiofrequency-Based Debridement

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).

Intervention Type: DEVICE

Mechanical Debridement

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

Intervention Type: DEVICE

Other Intervention Names

Werewolf Coblation Wand

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role: collaborator

Christopher Kaeding

OTHER

Sponsor Role: lead

Responsible Party

Christopher Kaeding

Professor - Clinical

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Christopher Kaeding, M.D.

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018H0244

Identifier Type: -

Identifier Source: org_study_id