Trials / Terminated
TerminatedNCT04361487
Circumferential Compression STITCH Repairs of Complex and Horizontal Cleavage Meniscal Tears
- Status
- Terminated
- Phase
- —
- Study type
- Observational
- Enrollment
- 33 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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. There are different types of tears in the meniscus. This study includes 2 of the tear types: horizontal cleavage and complex meniscal tears. Participants will be consented and enrolled in the study prior to knee surgery. Participants will complete surveys before surgery and data obtained from the medical record. In addition, standard of care x-rays and MRIs of the knee will be sent to the study. Participants will have their standard of care surgery to repair the knee using NOVOSTITCH PRO. Images and videos inside the knee during surgery may be sent to the study. Participants will be followed 2 years after surgery. There are a total of 5 follow-up visits: 2 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. Data will be obtained from medical records, surveys, MRIs, and radiographs. Up to 30 participants will have an optional needle endoscopy at the 6-month follow-up visit.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NOVOSTITCH™ PRO Meniscal Repair System | Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH™ PRO Meniscal Repair System |
Timeline
- Start date
- 2020-11-13
- Primary completion
- 2024-04-25
- Completion
- 2024-04-25
- First posted
- 2020-04-24
- Last updated
- 2026-02-24
- Results posted
- 2026-02-24
Locations
6 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT04361487. Inclusion in this directory is not an endorsement.