The NUsurface® Meniscus Implant Randomized Study is a multi-center, prospective randomized, interventional clinical trial to test the hypothesis that the NUsurface implant is superior to the non-surgical standard of care in treating the target population.The rationale for performing this clinical study is to gather clinical data to evaluate the safety and effectiveness of the NUsurface device compared to the Standard of Care.
The NUsurface® Meniscus Implant is intended for use in patients with medial compartment pain that have had a previous partial medial meniscectomy. Patients who meet the inclusion/exclusion criteria will be assigned by balanced randomization into one of two groups: the Meniscus Implants versus non-surgical standard of care. The KOOS (Knee injury and Osteoarthritis Outcome Score) and IKDC (International Knee Documentation Committee) forms will be used to provide a comprehensive evaluation of the patients' pre-intervention and post-intervention condition including activity levels, pain, swelling, locking, stability, support, sports activity, and quality of life assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
337
The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
OrthoIndy
Indianapolis, Indiana, United States
Brigham and Woman's Hospital
Boston, Massachusetts, United States
New England Baptist Hospital
Roxbury Crossing, Massachusetts, United States
Capital Region Orthopaedics
Overall Success Composite Endpoint
Overall Success is a composite endpoint computed at 24-Months whereby a subject must satisfy the pre-defined KOOS goals (KOOS Success), must have completed 24 Months with no disqualifying surgical intervention, and must have completed 24 Months with no device fracture and no subluxation on MRI confirmation.
Time frame: 2 years
Automatic Study Failure
The automatic treatment failure of the Control Group during the first 24-month period is any surgical intervention of the index knee. The automatic treatment failure of the Investigational Group during the first 24-month period is device removal or MRI detection of a dislocation or device fracture.
Time frame: 2 Years
KOOS Success
KOOS Success is an element that contributes to Overall Success by computing KOOS Pain Subscale at 24 months compared to baseline, and KOOS Overall score at 24 months compared to baseline. Scores for each of the five subscales are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems. For a subject to have KOOS Success their KOOS measures must be: KOOSpain ≥ 86.1 at 24 Months AND KOOSoverall ≥ 86.2 at 24 Months. Alternatively, a subject can have KOOS Success if KOOSpain ∆ (improvement from Baseline) ≥ 20 points at 24 Months AND KOOSoverall ∆ ≥ 20 points at 24 Months AND KOOSpain ≥ 40 points at 24 Months.
Time frame: 2 years
KOOS Subscale - Pain
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Time frame: 2 Years
KOOS Subscale - Symptoms
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
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Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
Albany, New York, United States
Lenox Hill Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
OrthoSouth
Memphis, Tennessee, United States
Advanced Orthopaedics
Richmond, Virginia, United States
Time frame: 2 Years
KOOS Subscale - ADL
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Time frame: 2 Years
KOOS Subscale - Sports and Recreation
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Time frame: 2 Years
KOOS Subscale - Quality of Life
The subscale results for KOOS Symptoms are converted to a 0 to 100 scale where 0 is the worse possible outcome and 100 is the best possible outcome.
Time frame: 2 Years
KOOS Overall Score
Average of all 5 KOOS Subscales
Time frame: 2 Years
VAS Pain Score
Visual Analog Scale (VAS) Pain Score is scored from the best lowest score of 0 to the worse pain score of 100.
Time frame: 2 Years
WOMET Normalized Score
Western Ontario Meniscal Evaluation Tool is a disease specific quality of life measurement tool for patients with meniscal lesions. Each question is scored from 0 (most favorable condition) to 100 (least favorable condition). When combining all scores from the 16 possible questions, the best and least symptomatic score is 0, and the highest and most symptomatic score possible is 1600. The score may be reported as a total overall score, as a total score for each domain, or as a percentage of normal by subtracting the total score from 1600, dividing by 1600, and multiplying by 100. If the normalized score is used, then the least favorable condition is 0 and the most favorable condition is 100.
Time frame: 2 Years
IKDC Subjective Knee Score
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form is a patient-reported measure of knee symptoms, function, and sports activity. The total score ranges from 0 to 100, where 0 represents the worst symptoms/function and 100 represents the best; higher scores indicate a better outcome. The score is calculated by summing responses to the 18 items, then transforming to a 0-100 scale using: \[(raw score - lowest possible raw score) / range of raw score\] × 100. No subscale scores are reported.
Time frame: 2 Years