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Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

NCT03084068 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2019-12-18

No results posted yet for this study

Summary

To determine the effectiveness of human dehydrated umbilical cord allograft in standard open rotator cuff repair as assessed by the American Shoulder and Elbow Surgeons (ASES) score 12 months post-op.

Conditions

  • Shoulder Injury
  • Shoulder Sprain
  • Supraspinatus Tear

Interventions

OTHER

Human dehydrated umbilical cord allograft

human dehydrated umbilical cord allograft

OTHER

Placebo

Open rotator cuff surgery with standard suture repair

Sponsors & Collaborators

  • MiMedx Group, Inc.

    lead INDUSTRY

Principal Investigators

  • David Mason, MD · MiMedx Group, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-01
Primary Completion
2019-01-17
Completion
2019-01-17

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 NCT03084068 on ClinicalTrials.gov