ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03678948
Recruitment Status : Not yet recruiting
First Posted : September 20, 2018
Last Update Posted : September 20, 2018
Sponsor:
Collaborator:
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Christopher Kaeding, Ohio State University

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.

Condition or disease Intervention/treatment Phase
Articular Cartilage Disorder of Knee Device: Radiofrequency-Based Debridement Device: Mechanical Debridement Phase 4

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Masking Description: Study subject will not be made aware of the treatment received until after completion of the research study.
Primary Purpose: Treatment
Official Title: Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Active Comparator: 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.
Device: 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).
Other Name: Werewolf Coblation Wand

Active Comparator: Mechanical Debridement Device: Mechanical Debridement
Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement




Primary Outcome Measures :
  1. Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale [ Time Frame: 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 :
  1. Visual Analogue Scale (VAS) [ Time Frame: 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.

  2. International Knee Documentation Committee (IKDC) subjective knee evaluation [ Time Frame: change from baseline at week 52 post-op ]
  3. International Knee Documentation Committee (IKDC) objective knee [ Time Frame: change from baseline at week 52 post-op ]
  4. Marx Activity Rating Scale (MARS) [ Time Frame: 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).

  5. Work Productivity and Activity Impairment (WPAI V2.0) [ Time Frame: 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

  6. MRI [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03678948


Contacts
Contact: Courtney K Wright 614-293-2410 Courtney.Wright@osumc.edu

Locations
United States, Ohio
The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
Columbus, Ohio, United States, 43202
Sponsors and Collaborators
Christopher Kaeding
Smith & Nephew, Inc.
Investigators
Principal Investigator: Christopher Kaeding, M.D. Ohio State University
  Study Documents (Full-Text)

Documents provided by Christopher Kaeding, Ohio State University:
Informed Consent Form  [PDF] July 9, 2018
Study Protocol  [PDF] July 2, 2018


Responsible Party: Christopher Kaeding, Professor - Clinical, Ohio State University
ClinicalTrials.gov Identifier: NCT03678948     History of Changes
Other Study ID Numbers: 2018H0244
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: September 20, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Cartilage Diseases
Musculoskeletal Diseases
Connective Tissue Diseases