Meniscectomy, Osteoarthritis
Conditions
Keywords
meniscectomy, meniscus, implant, koos, nusurface
Brief summary
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.
Detailed description
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.
Interventions
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
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.
Sponsors
Active Implants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Had \> 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI * Is between age 30 and 75 years (inclusive) at the time of study treatment * Has neutral alignment ±5º of the mechanical axis, as measured from the angle formed by a line drawn from the center of the femoral head to the medial tibial spine and a line drawn from the medial tibial spine and the center of the ankle joint * Has ≥ 2 mm intact medial meniscal rim capable of being fitted with a NUsurface® device AND is also recommended for the baseline non-surgical (and, if likely to receive benefit, any injection) therapies to be administered in the study. * Is willing to be entered into either arm of the study: implanted with the NUsurface device OR treated with the recommended control arm therapies. * Is willing and able to attend all follow up visits, complete all study questionnaires, and undergo required X-ray and MRI schedule * Is able and willing to understand and sign the Informed Consent Form * Is able to read and understand the English language * Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
Exclusion criteria
* Has a symptomatic knee because of a tear that could be addressed by a repeat partial meniscectomy leaving \> 4 mm of medial meniscus rim * Has evidence of a Outerbridge Grade IV cartilage loss on the medial tibial plateau or femoral condyle that potentially could contact a NUsurface implant (e.g., a focal lesion \> 0.5 cm2 correlating to a circular defect of \> 8 mm in diameter) * Has complete disruption of the posterior root attachment of the meniscus * Has lateral compartment pain and Grade III or Grade IV Outerbridge cartilage score in the lateral compartment * Has a varus or valgus knee deformity \> 5º requiring a tibial or femoral osteotomy * Has a laxity level of more than Grade II (IKDC), primary or secondary to an injury of the anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) and/or lateral collateral ligament (LCL) and/or medial collateral ligament (MCL) * Has significant trochlear dysplasia, patellar instability or symptomatic patellar misalignment * Has patellar compartment pain and Grade III or Grade IV Outerbridge cartilage score in the patellar compartment. * Compared to a normal knee, has obvious radiological evidence of medial femoral squaring, anatomical variance in the medial tibial plateau, or irregularly shaped cartilage surface * Had an ACL reconstruction performed \< 9 months prior to study treatment * Has a BMI \> 32.5 at the time of study treatment * Decides to receive (if eligible and an option) allograft medial meniscus transplantation * Received any type of prosthetic knee implant made of artificial non-resorbable plastic, metal or ceramic, not including the NUsurface® Meniscus Implant * Has a knee flexion contracture \> 10º * Has flexion \< 90º * Had a previous medial femoral condyle surgery (not including microfracture) or High Tibial Osteotomy (HTO) * Has insufficiency fractures or avascular necrosis of the medial compartment * Has an active infection or tumor (local or systemic) * Has any type of knee joint inflammatory disease including Sjogren's syndrome * Has neuropathic knee osteoarthropathy, also known as Charcot joint * Has any medical condition that does not allow possible arthroscopy of the knee * Has neurological deficit (sensory, motor, or reflex) * Is currently involved in another investigation of the lower extremity * Anticipates having another lower extremity surgery during the study period * Is contraindicated for hyaluronic acid injections (i.e., patients with known hypersensitivity \[allergy\] to hyaluronan \[sodium hyaluronate\] preparations); patients having knee joint infections or skin diseases or infections in the site of possible injections * Is contraindicated for corticosteroid injections (i.e., patients with allergy to any of the components or with idiopathic thrombocytopenic purpura) * Has received any corticosteroid knee injections ≤ 3 months prior to study treatment * Has chondrocalcinosis * Is on immunostimulating or immunosuppressing agents * Has ipsilateral or contralateral lower limb joint conditions that may affect ambulation or KOOS (e.g. have a leg length discrepancy \> 2.5 cm \[1 inch\], causing a noticeable limp) * Is a female who is lactating, expecting, or is intending to become pregnant during the study period * Is an active smoker * Is mentally incapacitated (incapable of appraising or controlling conduct) or have mental disability (e.g., dementia or Alzheimer's) * Is a prisoner * Is a patient who has economic incentive not to improve
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Success Composite Endpoint | 2 years | 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. |
| Automatic Study Failure | 2 Years | 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. |
| KOOS Success | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| KOOS Subscale - Pain | 2 Years | 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. |
| KOOS Subscale - Symptoms | 2 Years | 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. |
| KOOS Subscale - ADL | 2 Years | 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. |
| KOOS Subscale - Sports and Recreation | 2 Years | 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. |
| KOOS Subscale - Quality of Life | 2 Years | 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. |
| KOOS Overall Score | 2 Years | Average of all 5 KOOS Subscales |
| VAS Pain Score | 2 Years | Visual Analog Scale (VAS) Pain Score is scored from the best lowest score of 0 to the worse pain score of 100. |
| WOMET Normalized Score | 2 Years | 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. |
| IKDC Subjective Knee Score | 2 Years | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORElliott B Hershman, MD
Lenox Hill Hospital NYC
Participant flow
Pre-assignment details
Of the 337 assessed for eligibility there were 187 were excluded prior to Treatment Allocation ( 165 - Not Meeting Inclusion Criteria; 22 - Declined to Participate ) and 150 proceeded to Randomization.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 50.36 years STANDARD_DEVIATION 10.7 |
| Body Mass Index | 26.79 kg/m^2 STANDARD_DEVIATION 3.24 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 61 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| IKDC Subjective Knee Assessment | 42.35 units on a scale STANDARD_DEVIATION 13.21 |
| KOOS Score Overall | 47.60 units on a scale STANDARD_DEVIATION 12.62 |
| KOOS Subscore - Activities of Daily Living | 65.26 units on a scale STANDARD_DEVIATION 19.88 |
| KOOS Subscore - Pain | 53.19 units on a scale STANDARD_DEVIATION 13.62 |
| KOOS Subscore - Quality of Life | 27.56 units on a scale STANDARD_DEVIATION 16.9 |
| KOOS Subscore - Sports and Recreation | 37.46 units on a scale STANDARD_DEVIATION 21.93 |
| KOOS Subscore - Symptoms | 59.39 units on a scale STANDARD_DEVIATION 15.33 |
| Region of Enrollment United States | 66 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 96 Participants |
| Visual Analog Scale (VAS) Pain Score | 51.97 units on a scale STANDARD_DEVIATION 22.15 |
| WOMET Normalized Score | 39.05 units on a scale STANDARD_DEVIATION 16.58 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 61 | 0 / 66 |
| other Total, other adverse events | 57 / 61 | 6 / 66 |
| serious Total, serious adverse events | 29 / 61 | 12 / 66 |
Outcome results
None listed