Chondral Lesion Plus Partial Medial MeniscectomyACTNCT01803880
Mechanical vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
A study testing Mechanical Debridement and RF-Based Debridement in people with Chondral Lesion Plus Partial Medial Meniscectomy, run by Smith & Nephew, Inc. at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chondral Lesion Plus Partial Medial Meniscectomy
- What is being tested?
- Mechanical Debridement and RF-Based Debridement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 7 sitesUnited States
- Study dates
- 8 Mar 2013to 21 Jul 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects MUST meet ALL of the following criteria to be included in the study:
- Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
- Is male or non pregnant female ≥ eighteen (18) years of age
- MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
- Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
- Must be able to understand English (written and oral)
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- Must be available to come to all study related visits and is physically and mentally willing and able to comply with all post-operative evaluations
- Must be in general good health (as determined by the Investigator) based on screening assessments and medical history
- Intra-operative Inclusion Criteria
- Subjects MUST meet ALL of the following criteria to be included in the study:
- 1. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:
- Single, treatable chondral lesion, localized to the medial femoral condyle,
- ICRS Grade 2 with widely displaceable fibrillation or flaps or Grade 3A,
- < 4cm2 in size
Who cannot join
- Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- Body Mass Index (BMI) > 40 or index joint pain is due to BMI (as determined by Investigator)
- Requires bilateral knee surgery
- Any of the following conditions:
- active joint infections
- is immunocompromised, has Sickle Cell disease, has a primary bone disease (e.g., Paget's disease) or disorders that may adversely affect the healing process, or is terminally ill
Show all 48Show fewer
- inflammatory rheumatoid arthritis or other systemic inflammatory arthritis (i.e., gout)
- metastatic and/or neoplastic disease
- infectious, highly communicable diseases (e.g., active tuberculosis or active hepatitis)
- coagulation disorder or patient is receiving anti-coagulants
- documented evidence of a history (e.g. liver testing) of drug/alcohol abuse within 12 months of enrollment into this study
- diagnosed with a behavioral condition which could affect their ability to accurately comply with the study (e.g. developmental delay, attention deficit disorder, and autism)
- Any of the following conditions in the index limb or joint:
- Grade III or greater osteoarthritis as determined by AP radiograph (Kellgren-Lawrence classification)
- systemic steroid therapy or steroid intra-articular therapy within 4 weeks of enrollment into this study
- intra-articular viscosupplementation within 3 months of enrollment into this study
- osteomyelitis, septicemia, or other infections that may spread to other areas of the body
- fractures, osteocysts or osteolysis
- recurrent patellar instability (e.g., subluxation or dislocation)
- severe Varus or Valgus knee deformities (as determined by Investigator)
- symptomatic tear of the lateral meniscus
- avascular necrosis
- synovial disorders (e.g., pigmented villanodular synovitis)
- previous total or partial meniscectomy
- requires reconstruction or replacement of medial or lateral meniscus
- knee instability, malalignment, or patellar tracking dysfunction
- prior treatment for cartilage repair, including but not limited to ACI, Mosaicplasty and/or marrow stimulation procedures
- prior knee tendon and/or ligament repair or patellar surgery within 6 months of enrollment into this study
- Any of the following conditions in the contralateral limb or joint:
- greater than minimal abnormality as shown by clinical exam and/or imaging
- scheduled or to be scheduled for surgery over the course of this study
- involvement causing abnormal ambulation and non-compliance with post-operative rehabilitation guideline
- The subject has implanted metallic devices (insulin pumps, nerve stimulators, etc), medically implanted clips or other electronically, magnetically or mechanically activated implants that would contraindicate undergoing an MRI scan of the knee
- The subject has claustrophobia that would inhibit their ability to undergo an MRI scan of the index knee
- Receiving prescription narcotic pain medication for conditions unrelated to the index knee condition
- Cardiac pacemaker or other electronic implant(s)
- Pregnant and/or intending to become pregnant during this study period
- Participated in a clinical study within 30 days of enrollment into this study, or who is currently participating in another clinical study.
- Is a prisoner, or is known or suspected to be transient
- Is involved with Worker's Compensation unrelated to the index knee
- Is involved with health-related litigation
- Intra-operative Exclusion Criteria
- Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- Has more than 1 chondral lesion requiring treatment
- Requires concomitant procedures (i.e., anterior cruciate ligament repair, high tibial osteotomy), excluding partial medial meniscectomy
- Has a medial meniscal tear not requiring treatment
- Has a medial meniscal tear requiring a procedure other than partial meniscectomy
- Has a lateral meniscal tear requiring treatment
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Ohio State University
Columbus, Ohio, 43221
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, 46143
Andrews Research and Education Foundation, Inc.
Gulf Breeze, Florida, 32561
Methodist Center For Orthopedic Surgery
Houston, Texas, 77070
Basin Orthopedic Surgical Specialists
Odessa, Texas, 79761
University Orthopedics Center
State College, Pennsylvania, 16801
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
About this study
Official title: A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
The purpose of this study is to evaluate changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.
Read the detailed description
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration will be until the last subject enrolled reaches 104 weeks post-operative.
The study will be comprised of two parts:
Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Investigators must be qualified by training to perform procedures prior to use of either study device. This purpose of Part I will be to minimize variability with the recommended directions for use established in the instructions for use (IFU). Part I subjects will be followed per protocol follow-up requirements, and will be included in the safety population only. These subjects will be additive (to the safety population) to the 82 randomized subjects planned as part of the primary evaluation in Part II.
Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate enrollment of subjects in this part of the study following completion of Part I requirements. The Part II study implements a randomized adaptive study design, whereby an interim analysis will be conducted for sample size re-assessment. There is no intention of reducing the sample size as a result of this interim analysis; however, the sample size may be increased to either establish the non-inferiority and/or may be increased sufficiently to establish superiority depending on the results of the interim analysis.
- Being tested
- Mechanical Debridement, RF-Based Debridement
- Keywords
- Articular cartilage, Cartilage lesion, Cartilage defect, Radiofrequency, Debridement, Cartilage, Coblation, Knee, Meniscus, Meniscectomy, MR imaging, Mechanical debridement, Mechanical shaver, Torn meniscus, Arthroscopic knee surgery, Damaged cartilage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical DebridementDevice
Also called Mechanical Shaver
mechanical shaver that removes areas of damaged tissue
RF-Based DebridementDevice
Also called Paragon T2 ICW, FLOW 50 wand
Electrical energy that removes areas of damaged tissue (Coblation®)
| Study group | Role | What they receive |
|---|---|---|
| Mechanical Debridement | Active comparator | Mechanical shaver removes areas of damaged tissue Receives: Device: Mechanical Debridement |
| RF-based Debridement | Active comparator | Electrical energy removes areas of damaged tissue (Coblation®) Receives: Device: RF-Based Debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living [ADL], Function in Sport and Recreation [Sport/Rec] and knee related Quality of Life [QoL]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method).
Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems.
KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
Measured: Postop Week 52
Secondary outcomes (13)
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
The scores of three domains of IKDC Subjective Knee Evaluation Form (i.e., [1] symptoms, including pain, stiffness, swelling, locking/catching, and giving way; [2] sports and daily activities; and [3] current knee function) at Baseline, each of scheduled post-operative visits and changes from Baseline were summarized descriptively by treatment group.
Change from Baseline in IKDC = IKDC at Baseline + Pseudo-site + Treatment + Treatment*Pseudo-site
The IKDC score was interpreted by summing the scores for the individual questions and then transforming the score to a scale that ranged from 0 to 100:
Individual domain IKDC score = [raw score - lowest possible score/range of scores] x 100
The IKDC total score was interpreted as higher scores = higher function, lower scores = lower function.
Treatment*Pseudo-site interaction term was non-significant at the 0.05 level and hence was dropped from the statistical method.
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
Knee examination with respect to generalized laxity (tight, normal, lax) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.
The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.
There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:
IKDC score = (raw score - lowest possible score / range of scores) x100
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
Knee examination with respect to alignment (obvious varus, normal, obvious valgus) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.
The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.
There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:
IKDC score = (raw score - lowest possible score / range of scores) x100
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
Knee examination with respect to patella position (obvious baja, normal, obvious alta) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.
The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.
There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:
IKDC score = (raw score - lowest possible score / range of scores) x100
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
Knee examination with respect to patella subluxation/ dislocation (centered, subluxable, subluxed and dislocated) were summarized as number and percent of subjects in treatment group for Baseline and post-operative follow-up visits.
The IKDC Knee Evaluation Form was comprised of 3 domains: 1) symptoms including pain, stiffness, swelling, locking/catching, and giving way; 2) sports and daily activities; and 3) current knee function and knee function prior to knee injury.
There were 18 questions and the raw score was transformed to a 0 to 100 scale score as follows:
IKDC score = (raw score - lowest possible score / range of scores) x100
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in KOOS Scores From Baseline
The scores of 5 subscales of Knee Injury and Osteoarthritis Outcome Score (KOOS) (i.e., pain, other symptoms, function in daily living [ADL], function in sport and recreation [Sport/Rec], and knee-related Quality of Life [QoL]) change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the KOOS subscale score at each of the scheduled post-operative visits.
Each subscale response was based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). A score of 100 indicated no problems and a score of 0 indicated extreme problems.
The KOOS calculations were calculated as follows:
Individual KOOS subscale scores = 100 - (mean of the observed items within the subscale x100) / 4
Change from Baseline in KOOS at Week (x) or Day (x) = KOOS at Week (x) or Day (x) - KOOS at Baseline
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in Visual Analog Scale (VAS) Scores From Baseline
The VAS knee pain scores were assessed at Baseline, post-operative visits (Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET) and change from Baseline were summarized descriptively by treatment group. An ANCOVA model was used to compare the differences in the devices for change from Baseline in the VAS knee pain score at each of the scheduled post-operative visits. The model had change in VAS knee pain as the response variable and treatment, Baseline VAS knee pain, site, treatment-by-site interaction, lesion-grade, and lesion-grade interaction as independent variables.
Scores ranged from 0 to 100 with pain intensity measured as none, mild, moderate, or severe:
No pain (0-4) Mild pain (5-44) Moderate pain (45-74) Severe pain (75-100)
VAS scores were calculated as:
Change in VAS knee pain score from Baseline at Week (x) or Day (x) = VAS knee pain at Week (x) or Day (x) - VAS knee pain at Baseline
Measured: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
SF-12 PCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52 and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 PCS scores at each of the scheduled post-operative visits. The model had change in SF-12 PCS score as the response variable and treatment, Baseline SF-12 PCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables.
Results were expressed as the PCS. Scores could range from 0 (the worst) to 100 (the best).
SF-12 scores for PCS were calculated as:
Change in SF-12 PCS score from Baseline at Week (x) = PCS score at Week (x) - PCS score at Baseline
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
SF-12 MCS scores at Baseline, post-operative visits (Weeks 6, 12, 24, 36, 52, and 104) and changes from Baseline were summarized descriptively by treatment group. The SF-12 health survey categories included: physical functioning, role functioning physical, bodily pain, general health, vitality, social functioning, role functioning emotional, and mental health. An ANCOVA model was used to compare the difference in the devices for change from Baseline in the SF-12 MCS scores at each of the scheduled post-operative visits. The model had change in SF-12 MCS score as the response variable and treatment, Baseline SF-12 MCS score, site, treatment-by-site interaction, lesion-grade and treatment-by-lesion grade interaction as independent variables.
Results were expressed as the MCS. Scores could range from 0 (the worst) to 100 (the best).
SF-12 scores for MCS were calculated as:
Change in SF-12 MCS score from Baseline at Week (x) = MCS score at Week (x) - MCS score at Baseline
Measured: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses. Each individual category calculated a score of between -1 and +1. A score of -1 showed the worst improvement and a score of +1 showed the most improvement.
Summary total scores for EQ-5D-5L were calculated as:
Change in EQ-5D-5L score from Baseline at Week (x) or Day (x) = EQ-5D-5L score at Week (x) or Day (x) - EQ-5D-5L score at Baseline
Measured: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
The EQ-5D-5L and EQ-VAS surveys were assessed at the specified time points. The EQ-5D-5L score was composed of 5 dimensions to assess mobility, self-care, usual activities, pain/discomfort, and anxiety/depression based on participant's responses.
The EQ-VAS score ranged from 0 to 100 with higher scores representing better health and lower scores representing worse health.
Summary total scores for EQ-VAS were calculated as:
Change in EQ-VAS score from Baseline at Week (x) or Day (x) = EQ-VAS score at Week (x) or Day (x) - EQ-VAS score at Baseline
Measured: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Subject Satisfaction Postoperatively at Weeks 52 and 104
Subjects were questioned regarding their satisfaction with study treatment for knee pain.
Measured: Postop Weeks 52 and 104/ET
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
MRIs were obtained post-operatively at Day 10, obtained during the time period of Day 10 through Week 52, and again obtained during the time period of Week 52 through Week 104/ET). The images were evaluated using ICRS assessments of chondral lesions to determine the percentage of change in cartilage lesions over time post-operatively.
ICRS partial-thickness chondral lesion assessment scores:
Low-grade defect = less than 50% High-grade defect = 50% to 99%
Measured: Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study start8 Mar 2013
- Primary completion4 May 2017
- Study completion21 Jul 2017
Why it stopped: Unable to meet enrollment goals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chondral Lesion Plus Partial Medial MeniscectomyStudies of the same condition, open and under way.
- More trials run by Smith & Nephew, Inc.The sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Smith & Nephew, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jack Farr II, MD, Principal investigator, Orthopaedic Research Foundation, Inc.Beate Hansen, MD, PhD, Study chair, Vice President, Global Clinical Strategy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803880
- Sponsor's protocol ID
- SM-2012-02
- Acronym
- ACT
- Status last verified
- Mar 2019
- First submitted
- 15 Feb 2013
- Last updated
- 28 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double Blinded, Multicenter, Randomized, Controlled Trial to Evaluate Mechanical Debridement vs. Radiofrequency-Based Debridement in the Treatment of Articular Cartilage Lesions
- ClinicalTrials.gov ID
- NCT01803880
- Acronym / sponsor ID
- ACT / SM-2012-02
- Keywords
- Articular cartilage, Cartilage lesion, Cartilage defect, Radiofrequency, Debridement, Cartilage, Coblation, Knee
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to meet enrollment goals
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Smith & Nephew, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Mar 2013 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 21 Jul 2017 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Posted 28 Mar 2019
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 changes in clinical and imaging outcomes following arthroscopic treatment of a single medial femoral chondral lesion plus partial medial meniscectomy by Radiofrequency-Based debridement or Mechanical Debridement in subjects ≥ eighteen (18) years of age.
Detailed description
This is a non-inferiority, prospective, double blinded, multi-center, randomized, controlled, adaptive study design with enrollment of 82 randomized subjects at up to 13 study sites. Study duration will be until the last subject enrolled reaches 104 weeks post-operative.
The study will be comprised of two parts:
Part I: Part I will require all Investigators perform 1 to 3 procedures using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Investigators must be qualified by training to perform procedures prior to use of either study device. This purpose of Part I will be to minimize variability with the recommended directions for use established in the instructions for use (IFU). Part I subjects will be followed per protocol follow-up requirements, and will be included in the safety population only. These subjects will be additive (to the safety population) to the 82 randomized subjects planned as part of the primary evaluation in Part II.
Part II: Part II will consist of 82 randomized subjects. Each Investigator may initiate enrollment of subjects in this part of the study following completion of Part I requirements. The Part II study implements a randomized adaptive study design, whereby an interim analysis will be conducted for sample size re-assessment. There is no intention of reducing the sample size as a result of this interim analysis; however, the sample size may be increased to either establish the non-inferiority and/or may be increased sufficiently to establish superiority depending on the results of the interim analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mechanical Debridement | Active comparator | Device: Mechanical DebridementMechanical shaver removes areas of damaged tissue |
| RF-based Debridement | Active comparator | Device: RF-Based DebridementElectrical energy removes areas of damaged tissue (Coblation®) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Given written informed consent on the IRB/REB approved Consent Form specific to the study, prior to study participation
- Is male or non pregnant female ≥ eighteen (18) years of age
- MRI within 9 months of enrollment into this study confirming presence of a medial femoral chondral lesion and medial meniscal tear requiring a partial meniscectomy (as determined by the Investigator)
- Must present with pain in the index knee of moderate or severe (> 30 mm) as measured by the VAS
- Must be able to understand English (written and oral)
Key exclusion criteria (48 listed)
- Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
- Body Mass Index (BMI) > 40 or index joint pain is due to BMI (as determined by Investigator)
- Requires bilateral knee surgery
- Any of the following conditions:
- Any of the following conditions in the index limb or joint:
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 |
|---|---|---|
| Mechanical DebridementAlso: Mechanical Shavermechanical shaver that removes areas of damaged tissue | Device | Mechanical Debridement |
| RF-Based DebridementAlso: Paragon T2 ICW, FLOW 50 wandElectrical energy that removes areas of damaged tissue (Coblation®) | Device | RF-based Debridement |
Primary outcome
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative
Time frame: Postop Week 52
The scores of 5 subscales of KOOS (i.e., Pain, other Symptoms, Function in daily living [ADL], Function in Sport and Recreation [Sport/Rec] and knee related Quality of Life [QoL]) at Baseline, Week 52 and change from Baseline were summarized descriptively by treatment group. The average of KOOS subscale scores was considered as the primary endpoint. For any subject if the value of effectiveness parameter was missing at Week 52 then it was imputed by last observed post-Baseline value (LOCF method). Each subscale response is based on a 5-point Likert system with each response score ranging from 0 (no problems) to 4 (extreme problems). Each subscale score is calculated independently. A score of 100 indicated no problems and a score of 0 indicated extreme problems. KOOS subscale score = 100 - (mean of the observed items within the subscale x100 / 4)
13 secondary outcomes
Change in International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form Scores From Baseline.
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET)
Number of Participants Stratified by Generalized Laxity Level on IKDC Knee Evaluation
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Alignment Level on IKDC Knee Evaluation
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Patellar Position Level on IKDC Knee Evaluation
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Number of Participants Stratified by Patella Subluxation/Dislocation Level on IKDC Knee Evaluation
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in KOOS Scores From Baseline
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in Visual Analog Scale (VAS) Scores From Baseline
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Change in 12-Item Short Form Survey (SF-12) Scores From Baseline - Physical Component Summary (PCS) Score
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in SF-12 Scores From Baseline - Mental Component Summary (MCS) Score
Time frame: Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET
Change in EuroQoL 5 Dimensions, 5 Level Scale (EQ-5D-5L) Scores From Baseline (EQ-5D-5L Summary Total Score)
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Change in EQ-5D-5L Scores From Baseline (EQ-VAS Summary Total Score)
Time frame: Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET
Subject Satisfaction Postoperatively at Weeks 52 and 104
Time frame: Postop Weeks 52 and 104/ET
Magnetic Resonance Imaging (MRI) and International Cartilage Repair Society (ICRS) Chondral Lesion Assessments
Time frame: Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Jack Farr II, MD principal investigator
Orthopaedic Research Foundation, Inc.
Beate Hansen, MD, PhD study chair
Vice President, Global Clinical Strategy
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical Debridement and RF-Based Debridement in people with Chondral Lesion Plus Partial Medial Meniscectomy, run by Smith & Nephew, Inc. at 7 sites 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 14 inclusion and 48 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 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
Yes. Results are posted in the registry (first posted 28 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative (time frame: Postop Week 52). 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 28 Mar 2019.