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Rotation Medical Bioinductive Implant Database Registry

NCT02784600 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 483

Last updated 2021-10-18

No results posted yet for this study

Summary

The purpose of this clinical registry is to prospectively collect and compare preoperative and postoperative patient-reported data using validated shoulder-specific and health-related quality of life (QoL) instruments during real-world use of the Rotation Medical bioinductive implant to treat rotator cuff tears.

Conditions

  • Rotator Cuff Tear

Interventions

DEVICE

Bioinductive implant

Sponsors & Collaborators

  • Smith & Nephew, Inc.

    lead INDUSTRY

Principal Investigators

  • Louis McIntyre, MD · Phelps Medical Associates

  • Rachael Winter · Smith & Nephew, Inc.

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-25
Primary Completion
2020-01-16
Completion
2020-01-16
FDA Device
Yes

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 NCT02784600 on ClinicalTrials.gov