TerminatedNot Applicable

Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Stopped: Slow enrollment resulted in the decision to prematurely terminate the study

United States33 participantsStarted 2020-11-13

Plain-language summary

The purpose of this study is to understand the benefits and safety of the NOVOSTITCH PRO Meniscal Repair (NOVOSTITCH PRO) system. The meniscus is a tissue in the knee joint. The NOVOSTITCH PRO is used during surgery to fix meniscus tears in the knee. It is unknown whether fixing a meniscus tear is better than the approach of removing the tear. Data will be collected on participants prior to surgery, at surgery, and for 2 years after surgery.

Who can participate

Age range

18 Years – 70 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

. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board;
. 18 to 70 years of age, inclusive at the time of screening;
. History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
. Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
. If prior ligament reconstruction, the study knee is clinically stable;
. Meniscal repair to be performed arthroscopically;
. Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment;

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

Rate of Freedom From Reoperation at 12 Months After Surgery

Timeframe: 12 months

Trial details

NCT IDNCT04361487

SponsorSmith & Nephew, Inc.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-04-25

Results submitted2026-02-04

View on ClinicalTrials.gov More Meniscus Tear trials

Plain-language summary

Who can participate

Age range

18 Years – 70 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

. Able and willing to give informed consent by voluntarily providing written informed consent in accordance with governing Institutional Review Board;
. 18 to 70 years of age, inclusive at the time of screening;
. History indicative of meniscal pathology (e.g., pain, mechanical symptoms described as locking, clicking or giving way);
. Physical exam consistent with meniscus tear (e.g., locked joint, joint line tenderness and/or pain on meniscal compression);
. If prior ligament reconstruction, the study knee is clinically stable;
. Meniscal repair to be performed arthroscopically;
. Preoperative MRI evidence consistent with a horizontal cleavage or complex meniscus tear in the symptomatic compartment;

Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria