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
|Condition or disease||Intervention/treatment||Phase|
|Articular Cartilage Disorder of Knee||Device: Radiofrequency-Based Debridement Device: Mechanical Debridement||Phase 4|
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|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Study subject will not be made aware of the treatment received until after completion of the research study.|
|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|
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
- 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.
- 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.
- International Knee Documentation Committee (IKDC) subjective knee evaluation [ Time Frame: change from baseline at week 52 post-op ]
- International Knee Documentation Committee (IKDC) objective knee [ Time Frame: change from baseline at week 52 post-op ]
- 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).
- 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
- 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.
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
|Contact: Courtney K Wright||614-293-2410||Courtney.Wright@osumc.edu|
|United States, Ohio|
|The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute|
|Columbus, Ohio, United States, 43202|
|Principal Investigator:||Christopher Kaeding, M.D.||Ohio State University|