Trials / Unknown
UnknownNCT05491564
SoftStitch™ for All-Inside Meniscal Repair: Comparative Analysis of Patient Reported Outcome Measures
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 50 (estimated)
- Sponsor
- Arthrex, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 55 Years
- Healthy volunteers
- —
Summary
Acute and traumatic knee meniscus tears are a frequent occurrence. Evidence shows meniscal repair results in more favorable patient reported outcomes and articular cartilage preservation.1 This prospective, multicenter, single cohort, longitudinal study is intended to evaluate the effectiveness and safety profile of SoftStitch™ when used as standard of care for All-Inside Meniscal Repair. Electronic Patient Reported Outcome Measures (ePROM), functional assessments of the knee, Adverse Events of interest and Adverse Device Effects will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SoftStitch™ | The SoftStitch™ meniscal repair system includes a unique knotless all-inside meniscal repair implant with all suture fixation, eliminating the traditional hard plastic PEEK anchors used in the previous devices. |
Timeline
- Start date
- 2023-07-01
- Primary completion
- 2024-10-01
- Completion
- 2024-10-01
- First posted
- 2022-08-08
- Last updated
- 2023-02-02
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05491564. Inclusion in this directory is not an endorsement.