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Rotator Cuff Repair (RCR) With and Without OrthoADAPT Augmentation

NCT00957255 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-04-05

No results posted yet for this study

Summary

Prospective, randomized, multi-center, controlled study for patients undergoing open rotator cuff repair. Patients are stratified based on tear size to one of three groups. Each group is then randomized 1:1 to either repair with OrthoADAPT or repair without OrthoADAPT.

Conditions

  • Rotator Cuff Tear

Interventions

DEVICE

OrthoADAPT

soft tissue augmentation device

PROCEDURE

Standard of care

Standard of care rotator cuff repair

Sponsors & Collaborators

  • Synovis Surgical Innovations

    collaborator INDUSTRY

  • Baxter Healthcare Corporation

    lead INDUSTRY

Principal Investigators

  • Charles DePaolo, MD · Mission Health Research Institute

  • Pierce Scranton, MD · Seattle Medical Research Foundation

  • William Bryan, MD · Methodist Center for Orthopedic Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2010-04-30
Completion
2010-04-30

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 NCT00957255 on ClinicalTrials.gov