N/A
N=40
Evaluation of the Healicoil Suture Anchor for Rotator Cuff Repair
Rotator Cuff Tear Repair Anchors
Bottom Line
View on ClinicalTrials.gov: NCT02759458 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Sep 2022
Primary outcome: Primary: American Shoulder and Elbow Surgeons( ASES)-Shoulder Form — 30; 30 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Smith & Nephew Healicoil Anchor (Device); Smith & Nephew Twinfix Anchor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rush University Medical Center
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY American Shoulder and Elbow Surgeons( ASES)-Shoulder Form |
30; 30 | — |
| PRIMARY Single Assessment Numeric Evaluation (SANE) Form |
50; 48 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Patient is determined to have a full thickness rotator cuff tear either on pre-operative MRI scan and confirmed arthroscopically to be 1-3 cm
- Patient elects for surgical rotator cuff repair
- Written informed consent is obtained
Exclusion Criteria
- Revision surgery
- Irreparable rotator cuff tear
- Diabetes
- Workers Compensation
Data sourced from ClinicalTrials.gov (NCT02759458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.