Trials / Completed
CompletedNCT03985839
Safety and Performance of MICRORAPTOR™ Suture Anchors in Shoulder and Hip
Prospective Multi-Center Post-Market Clinical Follow-up Study to Evaluate Safety and Performance of the MICRORAPTOR REGENESORB, Knotless REGENESORB and Knotless PEEK Suture Anchors (and MINITAPE Sutures) in Shoulder and Hip Arthroscopic Instability Repair
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 299 (actual)
- Sponsor
- Smith & Nephew, Inc. · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
This is a prospective, multi-center, PMCF study to evaluate the safety and performance of the MICRORAPTOR REGENESORB suture anchors, MICRORAPTOR Knotless REGENESORB suture anchors, and MICRORAPTOR Knotless PEEK suture anchors implanted in 300 subjects needing reattachment of soft tissue to bone.
Detailed description
The purpose of this trial is to assess, by product, safety and performance post-market of the Microraptor Regenesorb, Microraptor Knotless Regenesorb, and Microraptor Knotless PEEK Suture Anchors. Approximately 18 sites (approximately 3 sites for study shoulder group and 3 sites for study hip group, per product) in the United States will participate in the study. This is an open-label study with consecutive enrollment. The study will continue for 24 months from the date that the last subject received the study treatment to the date that the last subject completes the study as planned. The study duration is planned for 36 months.
Conditions
- Labral Tear, Glenoid
- Acetabular Labrum Tear
- Bankart Lesions
- Anterior Shoulder Instability
- SLAP Lesion
- Rotator Cuff Tears
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | MICRORAPTOR™ REGENESORB™ Suture Anchor | Smith \& Nephew MICRORAPTOR™ REGENESORB™ Suture Anchor is a fixation device intended to provide secure attachment of soft tissue to bone. |
| DEVICE | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor | MICRORAPTOR™ Knotless REGENESORB™ Suture Anchor is fixation device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (REGENESORB™), and a non-absorbable PEEK (Polyether ether ketone) distal anchor tip. |
| DEVICE | MICRORAPTOR™ Knotless PEEK Suture Anchor | The MICRORAPTOR™ Knotless PEEK Suture Anchor is a class IIb device, which consists of an anchor on an inserter, and a suture threader. The anchor consists of the following components: a proximal anchor body (PEEK), and a non-absorbable PEEK distal anchor tip. |
Timeline
- Start date
- 2019-08-01
- Primary completion
- 2024-08-08
- Completion
- 2024-08-08
- First posted
- 2019-06-14
- Last updated
- 2025-03-17
Locations
12 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT03985839. Inclusion in this directory is not an endorsement.