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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
148
mechanical shaver that removes areas of damaged tissue
Electrical energy that removes areas of damaged tissue (Coblation®)
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Andrews Research and Education Foundation, Inc.
Gulf Breeze, Florida, United States
Orthopaedic Research Foundation, Inc.
Greenwood, Indiana, United States
Ohio State University
Columbus, Ohio, United States
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)
Time frame: Postop Week 52
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.
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
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University Orthopedics Center
State College, Pennsylvania, United States
Methodist Center For Orthopedic Surgery
Houston, Texas, United States
Basin Orthopedic Surgical Specialists
Odessa, Texas, United States
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
Time frame: 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
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
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
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
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
Time frame: 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
Time frame: 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
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
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
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
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
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)
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
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)
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
Time frame: 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.
Time frame: 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%
Time frame: Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET