An interventional study of Mechanical Debridement and RF-Based Debridement in Chondral Lesion Plus Partial Medial Meniscectomy, sponsored by Smith & Nephew, Inc.. Terminated at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-28.
Sponsored by Smith & Nephew, Inc. · Not applicable, Interventional, and Treatment
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.
Smith & Nephew, Inc. is the lead sponsor of 132 studies on the registry; 10 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects MUST meet ALL of the following criteria to be included in the study:
Intra-operative Inclusion Criteria
Subjects MUST meet ALL of the following criteria to be included in the study:
Exclusion Criteria
Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
Any of the following conditions:
Any of the following conditions in the index limb or joint:
Any of the following conditions in the contralateral limb or joint:
Intra-operative Exclusion Criteria
Subjects will be excluded from the study, if they meet ANY one (1) of the following criteria:
Mechanical shaver removes areas of damaged tissue
Device: Mechanical Debridement
Electrical energy removes areas of damaged tissue (Coblation®)
Device: RF-Based Debridement
mechanical shaver that removes areas of damaged tissue
Also known as: Mechanical Shaver
Electrical energy that removes areas of damaged tissue (Coblation®)
Also known as: Paragon T2 ICW, FLOW 50 wand
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
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
There were 148 subjects who initially signed a consent form, although 72 subjects withdrew consent prior to starting the study. This resulted in only 76 subjects actually starting the study and proceeding with study treatment.
| Milestone | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|---|
| Started | 19 | 28 | 29 |
| Completed | 13 | 18 | 14 |
| Not completed | 6 | 10 | 15 |
| Withdrew: Adverse event | 1 | 0 | 0 |
| Withdrew: Withdrawal by subject | 1 | 1 | 4 |
| Withdrew: Physician decision | 0 | 0 | 1 |
| Withdrew: Unable to return for follow-up visits | 0 | 1 | 2 |
| Withdrew: Lost to follow-up | 1 | 2 | 3 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Withdrew: Early study termination | 0 | 6 | 5 |
| Withdrew: Incomplete data entry by sites | 2 | 0 | 0 |
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)
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Change From Baseline in Knee and Osteoarthritis Outcomes Scores (KOOS) at Week 52 Post-operative | 31.94 ± 3.991 | 39.36 ± 4.210 |
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.
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| IKDC Summary Total Scores (Baseline) | 39.4 ± 14.56 | 37.3 ± 14.40 |
| Week 6 | 60.7 ± 15.42 | 64.4 ± 16.39 |
| Week 6 (Change from Baseline) | 21.0 ± 13.30 | 27.0 ± 22.17 |
| Week 12 | 69.8 ± 20.63 | 70.3 ± 20.24 |
| Week 12 (Change from Baseline) | 30.6 ± 19.57 | 33.1 ± 20.55 |
| Week 24 | 72.9 ± 21.21 | 70.2 ± 17.31 |
| Week 24 (Change from Baseline) | 33.4 ± 17.71 | 32.7 ± 21.07 |
| Week 36 | 70.2 ± 25.61 | 78.8 ± 15.50 |
| Week 36 (Change from Baseline) | 30.6 ± 22.05 | 41.1 ± 18.25 |
| Week 52 | 75.7 ± 25.61 | 80.4 ± 20.26 |
| Week 52 (Change from Baseline) | 30.6 ± 22.05 | 45.3 ± 21.20 |
| Week 104/ET | 77.2 ± 20.63 | 80.0 ± 21.66 |
| Week 104/ET (Change from Baseline) | 36.8 ± 21.84 | 45.8 ± 20.46 |
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
| Participants | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| IKDC Score at Baseline - Generalized Laxity — Tight | 0 | 1 |
| IKDC Score at Baseline - Generalized Laxity — Normal | 28 | 28 |
| IKDC Score at Baseline - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 6 - Generalized Laxity — Tight | 0 | 0 |
| IKDC Score at Week 6 - Generalized Laxity — Normal | 26 | 26 |
| IKDC Score at Week 6 - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 12 - Generalized Laxity — Tight | 0 | 0 |
| IKDC Score at Week 12 - Generalized Laxity — Normal | 25 | 26 |
| IKDC Score at Week 12 - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 24 - Generalized Laxity — Tight | 0 | 0 |
| IKDC Score at Week 24 - Generalized Laxity — Normal | 24 | 23 |
| IKDC Score at Week 24 - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 36 - Generalized Laxity — Tight | 0 | 1 |
| IKDC Score at Week 36 - Generalized Laxity — Normal | 19 | 21 |
| IKDC Score at Week 36 - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 52 - Generalized Laxity — Tight | 0 | 0 |
| IKDC Score at Week 52 - Generalized Laxity — Normal | 20 | 20 |
| IKDC Score at Week 52 - Generalized Laxity — Lax | 0 | 0 |
| IKDC Score at Week 104/ET - Generalized Laxity — Tight | 0 | 0 |
| IKDC Score at Week 104/ET - Generalized Laxity — Normal | 20 | 15 |
| IKDC Score at Week 104/ET - Generalized Laxity — Lax | 0 | 0 |
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
| Participants | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| IKDC Score at Baseline - Alignment — Obvious Varus | 1 | 0 |
| IKDC Score at Baseline - Alignment — Normal | 26 | 29 |
| IKDC Score at Baseline - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 6 - Alignment — Obvious Varus | 1 | 0 |
| IKDC Score at Week 6 - Alignment — Normal | 25 | 26 |
| IKDC Score at Week 6 - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 12 - Alignment — Obvious Varus | 0 | 1 |
| IKDC Score at Week 12 - Alignment — Normal | 25 | 25 |
| IKDC Score at Week 12 - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 24 - Alignment — Obvious Varus | 0 | 0 |
| IKDC Score at Week 24 - Alignment — Normal | 24 | 23 |
| IKDC Score at Week 24 - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 36 - Alignment — Obvious Varus | 0 | 1 |
| IKDC Score at Week 36 - Alignment — Normal | 19 | 21 |
| IKDC Score at Week 36 - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 52 - Alignment — Obvious Varus | 1 | 0 |
| IKDC Score at Week 52 - Alignment — Normal | 19 | 20 |
| IKDC Score at Week 52 - Alignment — Obvious Valgus | 0 | 0 |
| IKDC Score at Week 104/ET - Alignment — Obvious Varus | 1 | 1 |
| IKDC Score at Week 104/ET - Alignment — Normal | 19 | 14 |
| IKDC Score at Week 104/ET - Alignment — Obvious Valgus | 0 | 0 |
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
| Participants | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| IKDC Scores at Baseline - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Baseline - Patella Position — Normal | 28 | 29 |
| IKDC Scores at Baseline - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 6 - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 6 - Patella Position — Normal | 26 | 26 |
| IKDC Scores at Week 6 - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 12 - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 12 - Patella Position — Normal | 25 | 26 |
| IKDC Scores at Week 12 - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 24 - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 24 - Patella Position — Normal | 24 | 23 |
| IKDC Scores at Week 24 - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 36 - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 36 - Patella Position — Normal | 19 | 22 |
| IKDC Scores at Week 36 - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 52 - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 52 - Patella Position — Normal | 20 | 20 |
| IKDC Scores at Week 52 - Patella Position — Obvious Alta | 0 | 0 |
| IKDC Scores at Week 104/ET - Patella Position — Obvious Baja | 0 | 0 |
| IKDC Scores at Week 104/ET - Patella Position — Normal | 20 | 15 |
| IKDC Scores at Week 104/ET - Patella Position — Obvious Alta | 0 | 0 |
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
| Participants | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| IKDC Scores at Baseline - Subluxation/Dislocation — Centered | 28 | 29 |
| IKDC Scores at Baseline - Subluxation/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Baseline - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Baseline - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 6 - Subluxation/Dislocation — Centered | 26 | 25 |
| IKDC Scores at Week 6 - Subluxation/Dislocation — Subluxable | 0 | 1 |
| IKDC Scores at Week 6 - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 6 - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 12 - Subluxation/Dislocation — Centered | 25 | 26 |
| IKDC Scores at Week 12 - Subluxation/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Week 12 - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 12 - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 24 - Subluxation/Dislocation — Centered | 24 | 23 |
| IKDC Scores at Week 24 - Subluxation/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Week 24 - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 24 - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 36 - Subluxation/Dislocation — Centered | 19 | 21 |
| IKDC Scores at Week 36 - Subluxation/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Week 36 - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 36 - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 52 - Subluxation/Dislocation — Centered | 20 | 20 |
| IKDC Scores at Week 52 - Subluxation/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Week 52 - Subluxation/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 52 - Subluxation/Dislocation — Dislocated | 0 | 0 |
| IKDC Scores at Week 104/ET - Sublux/Dislocation — Centered | 20 | 15 |
| IKDC Scores at Week 104/ET - Sublux/Dislocation — Subluxable | 0 | 0 |
| IKDC Scores at Week 104/ET - Sublux/Dislocation — Subluxed | 0 | 0 |
| IKDC Scores at Week 104/ET - Sublux/Dislocation — Dislocated | 0 | 0 |
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
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Pain - Baseline | 46.2 ± 17.26 | 50.6 ± 13.10 |
| Pain - Week 6 | 70.9 ± 19.62 | 80.4 ± 14.90 |
| Pain - Week 6 (Change from Baseline) | 25.3 ± 16.92 | 29.9 ± 19.66 |
| Pain - Week 12 | 80.6 ± 20.05 | 82.3 ± 17.23 |
| Pain - Week 12 (Change from Baseline) | 35.8 ± 21.92 | 30.3 ± 19.83 |
| Pain - Week 24 | 78.5 ± 22.15 | 80.4 ± 15.39 |
| Pain - Week 24 (Change from Baseline) | 32.5 ± 21.91 | 29.1 ± 18.37 |
| Pain - Week 36 | 78.7 ± 25.98 | 89.0 ± 9.55 |
| Pain - Week 36 (Change from Baseline) | 29.6 ± 25.92 | 36.8 ± 12.94 |
| Pain - Week 52 | 81.5 ± 24.91 | 87.6 ± 18.30 |
| Pain - Week 52 (Change from Baseline) | 35.8 ± 21.98 | 38.2 ± 18.79 |
| Pain - Week 104/ET | 88.3 ± 15.18 | 88.5 ± 17.47 |
| Pain - Week 104/ET (Change from Baseline) | 38.9 ± 21.50 | 39.3 ± 15.17 |
| Other Symptoms - Baseline | 58.4 ± 20.72 | 54.7 ± 16.70 |
| Other Symptoms - Week 6 | 73.5 ± 17.64 | 75.7 ± 18.48 |
| Other Symptoms - Week 6 (Change from Baseline) | 16.0 ± 20.76 | 20.6 ± 22.70 |
| Other Symptoms - Week 12 | 81.3 ± 19.73 | 83.1 ± 15.14 |
| Other Symptoms - Week 12 (Change from Baseline) | 25.0 ± 25.63 | 28.3 ± 20.92 |
| Other Symptoms - Week 24 | 79.8 ± 20.22 | 80.4 ± 13.99 |
| Other Symptoms - Week 24 (Change from Baseline) | 21.9 ± 22.55 | 25.2 ± 18.67 |
| Other Symptoms - Week 36 | 74.1 ± 23.17 | 87.7 ± 10.61 |
| Other Symptoms - Week 36 (Change from Baseline) | 17.0 ± 24.90 | 31.7 ± 17.26 |
| Other Symptoms - Week 52 | 78.7 ± 24.12 | 88.0 ± 14.53 |
| Other Symptoms - Week 52 (Change from Baseline) | 19.8 ± 26.33 | 34.6 ± 19.15 |
| Other Symptoms - Week 104/ET | 83.9 ± 17.71 | 85.7 ± 15.57 |
| Other Symptoms -Week 104/ET (Change from Baseline) | 24.5 ± 23.53 | 34.8 ± 17.78 |
| ADLs - Baseline | 53.5 ± 21.48 | 57.3 ± 15.31 |
| ADLs - Week 6 | 76.6 ± 21.09 | 86.2 ± 12.18 |
| ADLs - Week 6 (Change from Baseline) | 23.3 ± 18.43 | 29.6 ± 16.26 |
| ADLs - Week 12 | 84.1 ± 21.02 | 85.3 ± 14.36 |
| ADLs - Week 12 (Change from Baseline) | 32.0 ± 24.33 | 27.0 ± 16.16 |
| ADLs - Week 24 | 84.6 ± 20.88 | 87.9 ± 12.05 |
| ADLs - Week 24 (Change from Baseline) | 31.1 ± 24.53 | 31.0 ± 16.94 |
| ADLs - Week 36 | 78.7 ± 23.58 | 91.3 ± 11.06 |
| ADLs - Week 36 (Change from Baseline) | 24.3 ± 24.32 | 32.0 ± 14.51 |
| ADLs - Week 52 | 83.6 ± 23.85 | 89.2 ± 17.98 |
| ADLs - Week 52 (Change from Baseline) | 30.4 ± 24.06 | 32.3 ± 18.07 |
| ADLs - Week 104/ET | 89.0 ± 16.72 | 90.8 ± 13.39 |
| ADLs - Week 104/ET (Change from Baseline) | 32.6 ± 24.53 | 36.3 ± 16.67 |
| Sport/Rec - Baseline | 29.9 ± 22.68 | 30.2 ± 23.58 |
| Sport/Rec - Week 6 | 54.1 ± 25.87 | 61.5 ± 24.25 |
| Sport/Rec - Week 6 (Change from Baseline) | 23.1 ± 27.00 | 29.4 ± 35.06 |
| Sport/Rec - Week 12 | 72.0 ± 24.66 | 67.0 ± 25.96 |
| Sport/Rec - Week 12 (Change from Baseline) | 42.3 ± 30.24 | 38.2 ± 28.53 |
| Sport/Rec - Week 24 | 65.6 ± 30.59 | 69.3 ± 22.88 |
| Sport/Rec - Week 24 (Change from Baseline) | 34.9 ± 32.46 | 40.4 ± 32.68 |
| Sport/Rec - Week 36 | 63.0 ± 33.02 | 75.9 ± 24.33 |
| Sport/Rec - Week 36 (Change from Baseline) | 32.8 ± 35.60 | 45.2 ± 29.38 |
| Sport/Rec - Week 52 | 73.0 ± 30.28 | 78.3 ± 25.09 |
| Sport/Rec - Week 52 (Change from Baseline) | 41.4 ± 30.56 | 51.5 ± 26.81 |
| Sport/Rec - Week 104/ET | 76.0 ± 26.49 | 77.8 ± 27.88 |
| Sport/Rec - Week 104/ET (Change from Baseline) | 44.2 ± 25.90 | 53.8 ± 29.38 |
| QoL - Baseline | 28.8 ± 16.78 | 28.4 ± 14.90 |
| QoL - Week 6 | 59.7 ± 21.11 | 59.7 ± 19.79 |
| QoL - Week 6 (Change from Baseline) | 31.0 ± 25.09 | 31.3 ± 26.69 |
| QoL - Week 12 | 66.5 ± 24.13 | 66.6 ± 25.55 |
| QoL - Week 12 (Change from Baseline) | 39.0 ± 27.56 | 37.7 ± 31.00 |
| QoL - Week 24 | 67.2 ± 26.98 | 70.7 ± 21.02 |
| QoL - Week 24 (Change from Baseline) | 36.2 ± 34.4 | 41.0 ± 24.70 |
| QoL - Week 36 | 66.3 ± 32.66 | 77.3 ± 23.82 |
| QoL - Week 36 (Change from Baseline) | 35.9 ± 31.86 | 47.4 ± 25.34 |
| QoL - Week 52 | 72.5 ± 28.42 | 75.6 ± 26.59 |
| QoL - Week 52 (Change from Baseline) | 41.9 ± 25.50 | 47.5 ± 27.01 |
| QoL - Week 104/ET | 79.1 ± 21.77 | 76.7 ± 25.38 |
| QoL - Week 104/ET (Change from Baseline) | 46.9 ± 25.29 | 50.8 ± 22.89 |
| Average KOOS Score - Baseline | 43.4 ± 17.82 | 44.2 ± 13.56 |
| Average KOOS Score - Week 6 | 67.0 ± 19.77 | 72.7 ± 14.47 |
| Average KOOS Score - Week 6 (Change from Baseline) | 23.7 ± 18.85 | 28.2 ± 20.86 |
| Average KOOS Score - Week 12 | 76.9 ± 20.81 | 76.9 ± 18.59 |
| Average KOOS Score - Week 12 (Change/Baseline) | 34.8 ± 23.84 | 32.3 ± 21.05 |
| Average KOOS Score - Week 24 | 75.1 ± 22.69 | 77.8 ± 15.70 |
| Average KOOS Score - Week 24 (Change/Baseline) | 31.3 ± 23.01 | 33.3 ± 20.17 |
| Average KOOS Score - Week 36 | 71.6 ± 26.41 | 84.2 ± 14.59 |
| Average KOOS Score - Week 36 (Change/Baseline) | 27.9 ± 25.78 | 38.6 ± 16.82 |
| Average KOOS Score - Week 52 | 77.9 ± 25.41 | 83.7 ± 19.66 |
| Average KOOS Score - Week 52 (Change/Baseline) | 33.9 ± 23.42 | 40.8 ± 19.97 |
| Average KOOS Score - Week 104/ET | 83.3 ± 17.88 | 83.9 ± 19.16 |
| Average KOOS Score - Week 104/ET (Change/Baseline) | 37.4 ± 21.47 | 43.0 ± 18.22 |
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
| units on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Baseline | 57.6 ± 19.68 | 59.8 ± 16.15 |
| Day 10 | 28.7 ± 23.62 | 17.6 ± 18.69 |
| Day 10 (Change from Baseline) | -29.0 ± 21.29 | -42.2 ± 23.77 |
| Week 6 | 17.8 ± 23.05 | 13.8 ± 18.71 |
| Week 6 (Change from Baseline) | -38.1 ± 22.75 | -44.5 ± 19.90 |
| Week 12 | 12.6 ± 17.71 | 15.2 ± 17.79 |
| Week 12 (Change from Baseline) | -45.8 ± 23.98 | -41.3 ± 21.18 |
| Week 24 | 15.3 ± 23.88 | 13.9 ± 15.38 |
| Week 24 (Change from Baseline) | -42.6 ± 21.98 | -44.2 ± 18.64 |
| Week 36 | 19.1 ± 26.63 | 7.9 ± 13.53 |
| Week 36 (Change from Baseline) | -37.5 ± 28.20 | -49.6 ± 17.18 |
| Week 52 | 11.5 ± 20.08 | 9.3 ± 19.97 |
| Week 52 (Change from Baseline) | -45.8 ± 20.74 | -49.5 ± 24.54 |
| Week 104/ET | 8.4 ± 14.22 | 9.9 ± 20.60 |
| Week 104/ET (Change from Baseline) | -47.9 ± 25.92 | -50.7 ± 30.82 |
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
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Baseline PCS | 36.5 ± 10.65 | 38.6 ± 9.63 |
| Week 6 PCS | 45.1 ± 9.14 | 46.6 ± 8.27 |
| Week 6 PCS (Change from Baseline) | 8.2 ± 12.62 | 6.7 ± 9.31 |
| Week 12 PCS | 50.0 ± 7.87 | 46.6 ± 8.27 |
| Week 12 PCS (Change from Baseline) | 13.4 ± 13.14 | 9.4 ± 10.49 |
| Week 24 PCS | 48.5 ± 9.60 | 50.2 ± 8.19 |
| Week 24 PCS (Change from Baseline) | 11.1 ± 13.14 | 11.6 ± 11.12 |
| Week 36 PCS | 46.8 ± 11.49 | 52.5 ± 6.98 |
| Week 36 PCS (Change from Baseline) | 9.3 ± 13.81 | 13.1 ± 10.43 |
| Week 52 PCS | 48.9 ± 10.24 | 52.5 ± 8.72 |
| Week 52 PCS (Change from Baseline) | 11.6 ± 10.99 | 14.6 ± 11.55 |
| Week 104/ET PCS | 51.9 ± 6.96 | 51.6 ± 8.35 |
| Week 104/ET PCS (Change from Baseline) | 14.1 ± 11.02 | 15.3 ± 11.42 |
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
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Baseline MCS | 55.9 ± 9.98 | 55.1 ± 9.52 |
| Week 6 MCS | 55.1 ± 8.44 | 57.5 ± 9.63 |
| Week 6 MCS (Change from Baseline) | -0.1 ± 8.87 | 3.4 ± 8.27 |
| Week 12 MCS | 55.6 ± 7.47 | 55.9 ± 7.75 |
| Week 12 MCS (Change from Baseline) | 0.5 ± 10.97 | 1.2 ± 8.05 |
| Week 24 MCS | 56.6 ± 5.32 | 56.9 ± 8.47 |
| Week 24 MCS (Change from Baseline) | 0.7 ± 10.17 | 2.6 ± 8.32 |
| Week 36 MCS | 55.5 ± 6.49 | 57.1 ± 4.81 |
| Week 36 MCS (Change from Baseline) | 0.1 ± 10.63 | 1.8 ± 7.61 |
| Week 52 MCS | 56.1 ± 7.19 | 56.1 ± 4.90 |
| Week 52 MCS (Change from Baseline) | 0.6 ± 9.46 | 1.5 ± 10.35 |
| Week 104/ET MCS | 56.1 ± 5.17 | 55.7 ± 9.91 |
| Week 104/ET MCS (Change from Baseline) | -0.4 ± 10.84 | 0.1 ± 10.54 |
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
| units on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| EQ-5D-5L Summary Total Score (Baseline) | 0.714 ± 0.1503 | 0.745 ± 0.910 |
| Day 10 | 0.738 ± 0.1309 | 0.788 ± 0.0967 |
| Day 10 (Change from Baseline) | 0.024 ± 0.1331 | 0.043 ± 0.1151 |
| Week 6 | 0.791 ± 0.1528 | 0.825 ± 0.0999 |
| Week 6 (Change from Baseline) | 0.083 ± 0.1080 | 0.081 ± 0.1318 |
| Week 12 | 0.823 ± 0.1614 | 0.854 ± 0.1145 |
| Week 12 (Change from Baseline) | 0.116 ± 0.1182 | 0.094 ± 0.1137 |
| Week 24 | 0.814 ± 0.1473 | 0.854 ± 0.1047 |
| Week 24 (Change from Baseline) | 0.100 ± 0.1436 | 0.105 ± 0.1269 |
| Week 36 | 0.806 ± 0.1650 | 0.914 ± 0.0895 |
| Week 36 (Change from Baseline) | 0.096 ± 0.1524 | 0.143 ± 0.0743 |
| Week 52 | 0.835 ± 0.1950 | 0.911 ± 0.1267 |
| Week 52 (Change from Baseline) | 0.135 ± 0.1502 | 0.162 ± 0.1362 |
| Week 104/ET | 0.843 ± 0.1290 | 0.906 ± 0.1298 |
| Week 104/ET (Change from Baseline) | 0.106 ± 0.1381 | 0.167 ± 0.1470 |
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
| score on a scale | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| EQ-VAS Summary Total Score (Baseline) | 74.9 ± 21.70 | 76.3 ± 17.90 |
| Day 10 | 80.7 ± 16.85 | 88.0 ± 8.87 |
| Day 10 (Change from Baseline) | 5.8 ± 18.42 | 11.7 ± 16.80 |
| Week 6 | 84.0 ± 13.99 | 89.5 ± 7.41 |
| Week 6 (Change from Baseline) | 10.5 ± 14.82 | 14.1 ± 17.87 |
| Week 12 | 84.6 ± 14.35 | 90.1 ± 7.06 |
| Week 12 (Change from Baseline) | 10.8 ± 13.11 | 14.3 ± 18.55 |
| Week 24 | 87.3 ± 12.97 | 88.4 ± 10.98 |
| Week 24 (Change from Baseline) | 13.3 ± 16.09 | 14.0 ± 16.63 |
| Week 36 | 84.7 ± 12.97 | 91.0 ± 6.01 |
| Week 36 (Change from Baseline) | 13.3 ± 16.09 | 15.0 ± 17.81 |
| Week 52 | 84.1 ± 18.50 | 90.2 ± 8.60 |
| Week 52 (Change from Baseline) | 8.6 ± 18.55 | 15.1 ± 17.24 |
| Week 104/ET | 87.1 ± 12.96 | 90.3 ± 11.55 |
| Week 104/ET (Change from Baseline) | 9.2 ± 13.04 | 14.9 ± 13.27 |
Subjects were questioned regarding their satisfaction with study treatment for knee pain.
| Participants | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|
| Week 52 — Extremely Satisfied | 0 | 0 |
| Week 52 — Very Satisfied | 12 | 16 |
| Week 52 — Somewhat Satisfied | 5 | 2 |
| Week 52 — Somewhat Dissatisfied | 2 | 2 |
| Week 52 — Very Dissatisfied | 0 | 0 |
| Week 52 — Extremely Dissatisfied | 0 | 0 |
| Week 104/ET — Extremely Satisfied | 0 | 0 |
| Week 104/ET — Very Satisfied | 15 | 13 |
| Week 104/ET — Somewhat Satisfied | 5 | 2 |
| Week 104/ET — Somewhat Dissatisfied | 0 | 0 |
| Week 104/ET — Very Dissatisfied | 0 | 0 |
| Week 104/ET — Extremely Dissatisfied | 0 | 0 |
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%
| units on a scale | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|---|
| Postop Day 10 (Baseline) - Percent (%) Lesion Fill | 50.5 ± 15.5 | 52.9 ± 16.6 | 53.5 ± 16.8 |
| Day 10 to Week 52 - <50% Change in Lesion Fill | -0.3 ± 8.1 | -1.9 ± 4.4 | 1.5 ± 6.6 |
| Day 10 to Week 52 - ≥50% Change in Lesion Fill | 1.2 ± 11.1 | -3.4 ± 5.9 | -5.5 ± 10.8 |
| Weeks 52 to 104/ET - <50% Change in Lesion Fill | -5.2 ± 13.4 | 2.9 ± 8.8 | -6.0 ± 11.9 |
| Weeks 52 to 104/ET - ≥50% Change in Lesion Fill | 1.2 ± 14.7 | -3.4 ± 8.6 | 3.7 ± 4.7 |
Collected over AEs were recorded from the time of surgery until subject completion, ET, or study termination, whichever happened first, assessed throughout the 24-month follow-up period.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Part I | 0/19 (0%) | 1/19 (5.3%) | 13/19 (68.4%) |
| Part II: RF-based Debridement | 0/28 (0%) | 2/28 (7.1%) | 26/28 (92.9%) |
| Part II: Mechanical Debridement | 0/29 (0%) | 1/29 (3.4%) | 19/29 (65.5%) |
| Event | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|---|
| GlioblastomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/19 | 0/28 | 0/29 |
| Papillary thyroid cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/19 | 0/28 | 0/29 |
| HerniaGeneral disorders | 0/19 | 1/28 | 0/29 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/19 | 1/28 | 0/29 |
| Patella fractureInjury, poisoning and procedural complications | 0/19 | 0/28 | 1/29 |
| Event | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement |
|---|---|---|---|
| ArthralgiaMusculoskeletal and connective tissue disorders | 5/19 | 20/28 | 13/29 |
| Musculoskeletal painMusculoskeletal and connective tissue disorders | 0/19 | 3/28 | 2/29 |
| Back painMusculoskeletal and connective tissue disorders | 2/19 | 2/28 | 0/29 |
| BursitisMusculoskeletal and connective tissue disorders | 2/19 | 0/28 | 0/29 |
| Joint effusionMusculoskeletal and connective tissue disorders | 2/19 | 0/28 | 0/29 |
| VIIth nerve paralysisNervous system disorders | 0/19 | 2/28 | 0/29 |
| DepressionPsychiatric disorders | 0/19 | 2/28 | 0/29 |
| Joint swellingMusculoskeletal and connective tissue disorders | 1/19 | 2/28 | 2/29 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/19 | 2/28 | 0/29 |
| ConstipationGastrointestinal disorders | 0/19 | 2/28 | 0/29 |
| Age, Continuous(years) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Mean | 54.1 ± 8.15 | 59.9 ± 7.22 | 58.0 ± 9.76 | 57.7 ± 8.68 |
| Age, Customized(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Age of Subjects — <40 years | 1 | 0 | 1 | 2 |
| Age of Subjects — ≥40 years | 18 | 28 | 28 | 74 |
| Sex: Female, Male(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Female | 8 | 13 | 11 | 32 |
| Male | 11 | 15 | 18 | 44 |
| Ethnicity (NIH/OMB)(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 4 | 6 |
| Not Hispanic or Latino | 19 | 26 | 25 | 70 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| White | 17 | 27 | 29 | 73 |
| Black or African American | 2 | 0 | 0 | 2 |
| Other | 0 | 1 | 0 | 1 |
| Hispanic | 0 | 1 | 0 | 1 |
| BMI(kg/m^2) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Mean | 28.4 ± 3.02 | 29.9 ± 3.41 | 29.0 ± 4.02 | 29.2 ± 3.57 |
| Total pre-debridement lesion size(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| ≤2 cm^2 | 13 | 19 | 23 | 55 |
| >2-4 cm^2 | 4 | 9 | 6 | 19 |
| Missing | 2 | 0 | 0 | 2 |
| Duration (days) since onset of symptoms for index knee(Participants) | Part I | Part II: RF-based Debridement | Part II: Mechanical Debridement | Total |
|---|---|---|---|---|
| Acute: ≤30 days | 0 | 3 | 2 | 5 |
| Subacute: 31 days - 6 months | 8 | 16 | 20 | 44 |
| Chronic: >6 months | 11 | 9 | 6 | 26 |
| Missing | 0 | 0 | 1 | 1 |
2 further baseline measures are reported on the registry.
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