- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03678948
Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43202
- The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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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.
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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 Names:
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Active Comparator: Mechanical Debridement
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Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale
Time Frame: change from baseline at week 52 post-op
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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.
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change from baseline at week 52 post-op
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analogue Scale (VAS)
Time Frame: change from baseline at week 52 post-op
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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.
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change from baseline at week 52 post-op
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International Knee Documentation Committee (IKDC) subjective knee evaluation
Time Frame: change from baseline at week 52 post-op
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change from baseline at week 52 post-op
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International Knee Documentation Committee (IKDC) objective knee
Time Frame: change from baseline at week 52 post-op
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change from baseline at week 52 post-op
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Marx Activity Rating Scale (MARS)
Time Frame: change from baseline at week 52 post-op
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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).
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change from baseline at week 52 post-op
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Work Productivity and Activity Impairment (WPAI V2.0)
Time Frame: change from 1 week post op to 6 weeks post-op
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Asks about the effect of patient knee injury on their ability to work and perform normal daily activities
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change from 1 week post op to 6 weeks post-op
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MRI
Time Frame: change from baseline at week 52 post-op
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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.
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change from baseline at week 52 post-op
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Christopher Kaeding, M.D., Ohio State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018H0244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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