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Efficacy of an Amniotic Fluid Derived Allograft, (FlōGraft®) in Rotator Cuff Repairs: A Prospective Study

NCT03379324 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-12-20

No results posted yet for this study

Summary

Rotator Cuff (RC) repair will be augmented with the injection of a human amniotic fluid derived allograft at the repair interface junction. A secondary injection will be administered at the time of repair in the supraspinatus muscle body medial to the musculotendonous junction.

Conditions

  • Rotator Cuff Tear
  • Fatty Atrophy

Interventions

BIOLOGICAL

Superiority of augmented repairs

4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body

BIOLOGICAL

Fat degeneration of supraspinatus muscle

4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body

Sponsors & Collaborators

  • Fondren Orthopedic Group L.L.P.

    collaborator OTHER

  • Texas Orthopedic Hospital

    collaborator UNKNOWN

  • Applied Biologics, LLC

    lead INDUSTRY

Principal Investigators

  • Gregory Stocks, MD · Texas Orthopedic Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-03-24
Primary Completion
2019-09-30
Completion
2019-09-30

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 NCT03379324 on ClinicalTrials.gov