The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant) (NCT02483988) | Clinical Trial Compass
CompletedNot Applicable
The SUN Clinical Trial (Safety Utilizing NUsurface Meniscus Implant)
United States115 participantsStarted 2015-12
Plain-language summary
The NUsurface® Meniscus Implant SUN Clinical Trial is a multi-center, single-arm, prospective, open label, non-randomized, observational clinical trial to gather safety and probable clinical benefit data on the NUsurface® Meniscus Implant in treated the target population.
Who can participate
Age range30 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Had \> 6 months ago a medial partial meniscectomy as confirmed by patient history and MRI
✓. Has a KOOS Pain of ≤ 75 (100 being the highest attainable and no pain)
✓. 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
✓. Is able to do the study required follow-up visits, questionnaires, X-rays and MRI's
✓. Is able to read and understand the English language if treated at a U.S. site or read and understand one of the official country languages if treated at a site Outside the U.S.
✓. Is able and willing to understand and sign the Informed Consent Form
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)
What they're measuring
1
Safety assessed by Serious and non-serious, device-related and non-device related adverse events
. 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.