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Suture Anchor Comparison in Rotator Cuff Repairs

NCT02350647 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2021-01-13

Study results available
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Summary

Patients will be randomized to receive HEALICOIL™ REGENESORB (the study anchor) or TWINFIX Ultra HA, a similar comparative product, for use in the repair of their shoulder injury. They will be asked to complete questionnaires throughout the study and will receive an MRI, CT and multiple ultrasound images. The MRIs and radiographs will be used to assess bony ingrowth at the repair site, and the ultrasound to assess repair success rate of the rotator cuff. The clinical and radiological outcomes will be compared between the study and control groups. It is hypothesized that there will be 85% high quality ossification at anchor site for HEALICOIL REGENESORB and 49.9% high quality ossification for TWINFIX Ultra HA at 24 months.

Conditions

  • Rotator Cuff Injury

Interventions

DEVICE

Suture Anchor HEALOCOIL

Rotator cuff tears will be repaired intraoperatively using suture anchors

DEVICE

Suture anchor Twinfix Ultra HA

Sponsors & Collaborators

  • The Hawkins Foundation

    lead OTHER

Principal Investigators

  • Stefan Tolan, MD · Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2019-03-31
Completion
2019-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02350647 on ClinicalTrials.gov