At a glance
ClinicalIndex Comparison Record- ✓Full-thickness rotator cuff tear confirmed on pre-operative MRI and arthroscopic inspection, measuring 1–3 cm
- ✓Patient elects for surgical rotator cuff repair
- ✕Revision rotator cuff surgery
- ✕Irreparable rotator cuff tear
- ✕Diabetes
- ✕Workers' Compensation cases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Healicoil Suture Anchor for Rotator Cuff Repair
In Brief
A clinical study evaluating Smith & Nephew Healicoil Anchor and Smith & Nephew Twinfix Anchor for Rotator Cuff Tear Repair Anchors. Completed, enrolled 40 participants.
Detailed Summary
The purpose of the proposed study is to evaluate a new anchor for rotator cuff repair, the Smith \& Nephew Healicoil anchor. This anchor utilizes a small open-construct design to promote bone-in growth and potentially allow for the release of bone marrow factors into the repair site. In vivo ovine studies comparing the Arthrex BioComposite Corkscrew FT rotator cuff anchor to the Arthrex SwivelLock anchor have shown superior bone in-growth. Thus, this study consists of three separate aims in order to clinically and biochemically investigate the capabilities of the Healicoil anchor and its efficacy in rotator cuff repair. One, evaluate the bone in growth of the anchor compared to a standard poly-ether ether ketone (PEEK) anchor. Two, analyze the marrow elements that are released into the repair site through the open construct. Three, compare the functional outcomes of patients with rotator cuff repairs using the Healicoil anchor compared to a traditional Twinfix PEEK anchor.