Articular Cartilage Disorder of KneeNCT03678948
Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
A study testing Radiofrequency-Based Debridement and Mechanical Debridement in people with Articular Cartilage Disorder of Knee, run by Christopher Kaeding at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Articular Cartilage Disorder of Knee
- What is being tested?
- Radiofrequency-Based Debridement and Mechanical Debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2018to 8 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center Jameson Crane Sports Medicine Institute
Columbus, Ohio, 43202
About this study
Official title: Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
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.
Read the 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
- Being tested
- Radiofrequency-Based Debridement, Mechanical Debridement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiofrequency-Based DebridementDevice
Also called Werewolf Coblation Wand
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 DebridementDevice
Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement
| Study group | Role | What they receive |
|---|---|---|
| Radiofrequency-Based Debridement | Active comparator | 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. Receives: Device: Radiofrequency-Based Debridement |
| Mechanical Debridement | Active comparator | Not described Receives: Device: Mechanical Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: change from baseline at week 52 post-op
Secondary outcomes (6)
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.
Measured: change from baseline at week 52 post-op
International Knee Documentation Committee (IKDC) subjective knee evaluation
Measured: change from baseline at week 52 post-op
International Knee Documentation Committee (IKDC) objective knee
Measured: change from baseline at week 52 post-op
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).
Measured: change from baseline at week 52 post-op
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
Measured: change from 1 week post op to 6 weeks post-op
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.
Measured: change from baseline at week 52 post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start8 Nov 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
Why it stopped: Sponsor discontinuing research
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Disorder of KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christopher Kaeding
- Sponsor type
- University, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Responsible party
- Sponsor-investigator, Christopher Kaeding, Ohio State University
- Investigators
- Christopher Kaeding, M.D., Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03678948
- Sponsor's protocol ID
- 2018H0244
- Status last verified
- Sep 2021
- First submitted
- 30 Aug 2018
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Radiofrequency-Based Debridement vs. Mechanical Debridement for the Treatment of Articular Cartilage Lesions
- ClinicalTrials.gov ID
- NCT03678948
- Acronym / sponsor ID
- 2018H0244
- Conditions
- Articular Cartilage Disorder of Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor discontinuing research
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Christopher KaedingUniversity, hospital or other
- Collaborators
- Smith & Nephew, Inc.
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radiofrequency-Based Debridement | Active comparator | Device: Radiofrequency-Based DebridementThe 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. |
| Mechanical Debridement | Active comparator | Device: Mechanical Debridement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- < 30% joint space narrowing as seen on x-ray (merchant view, AP and PA Rosenberg)
Key exclusion criteria (13 listed)
- 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:
- Pregnant and/or intending to become pregnant during this study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiofrequency-Based DebridementAlso: Werewolf Coblation WandIn 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). | Device | Radiofrequency-Based Debridement |
| Mechanical DebridementArthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement | Device | Mechanical Debridement |
Primary outcome
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.
6 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: change from baseline at week 52 post-op
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
Work Productivity and Activity Impairment (WPAI V2.0)
Time frame: change from 1 week post op to 6 weeks post-op
MRI
Time frame: change from baseline at week 52 post-op
Results and safety
The study was stopped early (reason given: Sponsor discontinuing research). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher Kaeding, M.D. principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Radiofrequency-Based Debridement and Mechanical Debridement in people with Articular Cartilage Disorder of Knee, run by Christopher Kaeding at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor discontinuing research). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee and Osteoarthritis Outcome Scores (KOOS) activity subscale (time frame: change from baseline at week 52 post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2021.