Back to resultsRadiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Primary Purpose
Articular Cartilage Disorder of Knee
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Radiofrequency-Based Debridement
Mechanical Debridement
Sponsored by
About this trial
This is an interventional treatment trial for Articular Cartilage Disorder of Knee
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
Sites / Locations
- The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Radiofrequency-Based Debridement
Mechanical Debridement
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Visual Analogue Scale (VAS)
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
International Knee Documentation Committee (IKDC) objective knee
Marx Activity Rating Scale (MARS)
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)
Asks about the effect of patient knee injury on their ability to work and perform normal daily activities
MRI
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.
Full Information
NCT ID
NCT03678948
First Posted
August 30, 2018
Last Updated
September 24, 2021
Sponsor
Christopher Kaeding
Collaborators
Smith & Nephew, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03678948
Brief Title
Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Official Title
Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor discontinuing research
Study Start Date
November 8, 2018 (Actual)
Primary Completion Date
February 8, 2021 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christopher Kaeding
Collaborators
Smith & Nephew, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Articular Cartilage Disorder of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Study subject will not be made aware of the treatment received until after completion of the research study.
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiofrequency-Based Debridement
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Mechanical Debridement
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Radiofrequency-Based Debridement
Other Intervention Name(s)
Werewolf Coblation Wand
Intervention Description
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
Intervention Name(s)
Mechanical Debridement
Intervention Description
Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement
Primary Outcome Measure Information:
Title
Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale
Description
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.
Time Frame
change from baseline at week 52 post-op
Secondary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
change from baseline at week 52 post-op
Title
International Knee Documentation Committee (IKDC) subjective knee evaluation
Time Frame
change from baseline at week 52 post-op
Title
International Knee Documentation Committee (IKDC) objective knee
Time Frame
change from baseline at week 52 post-op
Title
Marx Activity Rating Scale (MARS)
Description
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).
Time Frame
change from baseline at week 52 post-op
Title
Work Productivity and Activity Impairment (WPAI V2.0)
Description
Asks about the effect of patient knee injury on their ability to work and perform normal daily activities
Time Frame
change from 1 week post op to 6 weeks post-op
Title
MRI
Description
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.
Time Frame
change from baseline at week 52 post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher Kaeding, M.D.
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
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