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Pilot Study of Augment Rotator Cuff for Surgical Treatment of Full Thickness Rotator Cuff Tears

NCT01256242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2019-02-19

No results posted yet for this study

Summary

Study Purpose: To evaluate the safety and performance of Augment Rotator Cuff as a primary surgical treatment for full thickness rotator cuff tears. The hypothesis is that Augment Rotator Cuff will be easy to deliver as an inter-positional graft placed between the rotator cuff tendon and the humeral head providing further enhanced tendon to bone healing without adding any additional safety risk to the patient.

Study Rationale: To evaluate the safety and performance Augment™ Rotator Cuff in surgical intervention of a torn rotator cuff and to obtain preliminary data to support the rationale for a subsequent pivotal clinical trial.

Conditions

  • Full Thickness Rotator Cuff Tear

Interventions

DEVICE

Augment Rotator Cuff

rhPDGF-BB and bovine collagen matrix

PROCEDURE

Standard Suture Repair

standard suture repair

Sponsors & Collaborators

  • BioMimetic Therapeutics

    lead INDUSTRY

Principal Investigators

  • Robert Litchfield, MD, FRCSC · Fowler Kennedy Sport Medicine Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-24
Primary Completion
2012-11-16
Completion
2012-11-16

Countries

  • Canada

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 NCT01256242 on ClinicalTrials.gov