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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical Debridement | Active Comparator | Mechanical shaver removes areas of damaged tissue |
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| RF-based Debridement | Active Comparator | Electrical energy removes areas of damaged tissue (Coblation®) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mechanical Debridement | Device | mechanical shaver that removes areas of damaged tissue |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) | Postop Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria
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:
1. Arthroscopic confirmation of a lesion requiring treatment meeting the following parameters:
Exclusion Criteria
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:
Any of the following conditions in the contralateral limb or joint:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Jack Farr II, MD | Orthopaedic Research Foundation, Inc. | Principal Investigator |
| Beate Hansen, MD, PhD | Vice President, Global Clinical Strategy | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson Orthopaedic Institute | Tucson | Arizona | 85712 | United States | ||
| Andrews Research and Education Foundation, Inc. |
Part I required all qualified investigators to perform 1 to 3 procedures using the study devices for the purpose of minimizing variability with the recommended directions for use established in the instructions for use. Part I subjects were to be included in the safety population only.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part I | Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only. |
| FG001 | Part II: RF-based Debridement |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 27, 2016 | Sep 4, 2018 |
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| RF-Based Debridement | Device | Electrical energy that removes areas of damaged tissue (Coblation®) |
|
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| 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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% | Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET |
| Gulf Breeze |
| Florida |
| 32561 |
| United States |
| Orthopaedic Research Foundation, Inc. | Greenwood | Indiana | 46143 | United States |
| Ohio State University | Columbus | Ohio | 43221 | United States |
| University Orthopedics Center | State College | Pennsylvania | 16801 | United States |
| Methodist Center For Orthopedic Surgery | Houston | Texas | 77070 | United States |
| Basin Orthopedic Surgical Specialists | Odessa | Texas | 79761 | United States |
Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself. |
| FG002 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Part I | Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only. |
| BG001 | Part II: RF-based Debridement | Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself. |
| BG002 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Total pre-debridement lesion size | Count of Participants | Participants |
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| Duration (days) since onset of symptoms for index knee | Count of Participants | Participants |
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| Knee Alignment | Count of Participants | Participants |
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| Narrowest width of meniscal rim post-operatively (radial measurement of meniscus post resection) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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) | ITT Population | Posted | Least Squares Mean | Standard Error | score on a scale | Postop Week 52 |
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| Secondary | 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. | Not all participants completed the IKDC score questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/Early Termination (ET) |
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| Secondary | 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 | Not all participants completed the IKDC score questionnaires. | Posted | Count of Participants | Participants | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the IKDC score questionnaires. | Posted | Count of Participants | Participants | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the IKDC score questionnaires. | Posted | Count of Participants | Participants | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the IKDC score questionnaires. | Posted | Count of Participants | Participants | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the KOOS questionnaires. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the VAS pain score questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the SF-12 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the SF-12 questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Postop Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the EQ-5D-5L questionnaire. | Posted | Mean | Standard Deviation | units on a scale | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | 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 | Not all participants completed the EQ-VAS questionnaire. | Posted | Mean | Standard Deviation | score on a scale | Baseline, Postop Day 10, Weeks 6, 12, 24, 36, 52, and 104/ET |
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| Secondary | Subject Satisfaction Postoperatively at Weeks 52 and 104 | Subjects were questioned regarding their satisfaction with study treatment for knee pain. | Not all participants completed the subject satisfaction questionnaire. | Posted | Count of Participants | Participants | Postop Weeks 52 and 104/ET |
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| Secondary | 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% | Only Baseline subjects and subjects showing a percentage change in cartilage signal were included in the imaging results. | Posted | Mean | Standard Deviation | units on a scale | Postop Day 10, Day 10 to Week 52, Week 52 to Week 104/ET |
|
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.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Part I | Part I: All Investigators were required to perform 1 to 3 procedures using the study device to minimize variability relating to the technique recommended in the IFU. These subjects were followed per protocol and analyzed for safety findings only. | 0 | 19 | 1 | 19 | 13 | 19 |
| EG001 | Part II: RF-based Debridement | Radiofrequency-Based Debridement was performed using the Quantum 2 Controller plus Paragon T2 ICW Wand or the WEREWOLF Controller plus FLOW 50 Wand. Both systems use a controlled RF-based plasma process (with the trademark 'COBLATION'). In this process, RF energy is used to excite the water molecules in a conductive medium to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds excising or dissolving (i.e., ablating) soft tissue at relatively low temperatures (typically 40 degrees C to 70 degrees C). The mechanism of action is a chemical process and not a function of the RF energy itself. | 0 | 28 | 2 | 28 | 26 | 28 |
| EG002 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. | 0 | 29 | 1 | 29 | 19 | 29 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia | General disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Glioblastoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
| |
| Patella fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Papillary thyroid cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (18.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment | Note: only 1 reported event of Arthralgia was assessed as related to study device. |
|
| Urinary tract infection | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| VIIth nerve paralysis | Nervous system disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | CTCAE v4.03 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Joint swelling | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Hernia Pain | General disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Flank pain | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | CTCAE v4.03 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Joint effusion | Musculoskeletal and connective tissue disorders | CTCAE v4.03 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (18.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA (18.1) | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA (18.1) | Systematic Assessment |
|
Due to early termination of the study, all inferential analyses were noted as descriptive and the clinical outcome results should be interpreted with caution.
Authorship and contents of publications shall be discussed between each Principal Investigator and Sponsor. Sponsor shall serve as coordinator of multi-center study disclosures and, in event of a disagreement among investigators, Sponsor shall determine resolution of any such dispute. Sponsor shall be furnished copies of any proposed multi-center publication or disclosure at least 90 days prior to the proposed date for submission for publication or disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Mangin, Director, Global Clinical Strategy | Smith & Nephew, Inc | M +1 (512) 913-8192 | stephan.mangin@smith-nephew.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 10, 2017 | Sep 4, 2018 | SAP_001.pdf |
| ≥40 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black or African American |
|
| Other |
|
| Hispanic |
|
| >2-4 cm^2 |
|
| Missing |
|
| Subacute: 31 days - 6 months |
|
| Chronic: >6 months |
|
| Missing |
|
| Valgus malalignment |
|
| Normal |
|
| >3º |
|
| Missing |
|
| Non-Inferiority |
Non-inferiority Margin = 10 points. Non-inferiority of study device was concluded if lower limit of one-sided 97.5% CI for treatment difference <10. Superiority of study device was established if LS means of treatment difference and lower limit of one-sided 97.5% CI for treatment difference ≤0. |
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| Part II: Mechanical Debridement |
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| Part II: Mechanical Debridement |
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 |
| Part II: Mechanical Debridement |
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| OG001 |
| Part II: Mechanical Debridement |
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| OG002 | Part II: Mechanical Debridement | Mechanical debridement (i.e., mechanical shaver) was used as the control debridement for the treatment of chondral lesions. |
|
|
| Normal |
|
| Lax |
|
| Normal |
|
| Lax |
|
| Normal |
|
| Lax |
|
| Normal |
|
| Lax |
|
| Normal |
|
| Lax |
|
| Normal |
|
| Lax |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Valgus |
|
| Normal |
|
| Obvious Alta |
|
| Normal |
|
| Obvious Alta |
|
| Normal |
|
| Obvious Alta |
|
| Normal |
|
| Obvious Alta |
|
| Normal |
|
| Obvious Alta |
|
| Normal |
|
| Obvious Alta |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Subluxable |
|
| Subluxed |
|
| Dislocated |
|
| Very Satisfied |
|
| Somewhat Satisfied |
|
| Somewhat Dissatisfied |
|
| Very Dissatisfied |
|
| Extremely Dissatisfied |
|