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 range
30 Years – 75 Years
Sex
ALL
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety assessed by Serious and non-serious, device-related and non-device related adverse events
. 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.