We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 29 for:    umbilical cord allograft
Previous Study | Return to List | Next Study

Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03084068
Recruitment Status : Completed
First Posted : March 20, 2017
Last Update Posted : December 18, 2019
Information provided by (Responsible Party):
MiMedx Group, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Shoulder Injury Shoulder Sprain Supraspinatus Tear Other: Human dehydrated umbilical cord allograft Other: Placebo Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : January 17, 2019
Actual Study Completion Date : January 17, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dehydration

Arm Intervention/treatment
Experimental: Human umbilical cord allograft
Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft
Other: Human dehydrated umbilical cord allograft
human dehydrated umbilical cord allograft

Placebo Comparator: Placebo Control
Open Rotator Cuff Repair with standard suture repair
Other: Placebo
Open rotator cuff surgery with standard suture repair

Primary Outcome Measures :
  1. ASES score [ Time Frame: 12 months ]
    The primary endpoint of the study is the number of subjects achieving a 20% increase from baseline in the overall ASES score at 12 months post-op.

Secondary Outcome Measures :
  1. Constant Murley Score [ Time Frame: 12 months ]
    Comparison of Constant scores between the two groups at each study time point

  2. Shoulder range of motion [ Time Frame: 12 months ]
    Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.

  3. VAS Pain scores [ Time Frame: 12 months ]
    Change in patient reported pain from baseline

  4. Incidence of tendon re-tear [ Time Frame: 12 months ]
    Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists

  5. Incidence of adverse events [ Time Frame: 12 months ]
    Incidence of adverse events

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. MRI confirmed diagnosis of a full thickness supraspinatus tendon tear necessitating surgical intervention (rotator cuff repair)
  2. Subject is male or female age 18 or older
  3. Subject is willing and able to provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study

Exclusion Criteria:

Subjects who meet ANY of the following criteria will be excluded from the study:

  1. Shoulder pain primarily attributed to any of the following:

    1. Ligament rupture due to use of fluoroquinolones
    2. Capsular tear
    3. Fracture of the humeral head
    4. Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
    5. Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
    6. Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
  2. Known history of poor compliance with medical treatments
  3. Subject has bilateral supraspinatus tendon tear
  4. Subject has signs and symptoms of an active infection of the shoulder joint
  5. Retraction of the supraspinatus tendon exceeding 1.5 cm in length
  6. Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
  7. Subject has had previous surgery in the target arm within the past 6 months prior to treatment or plans to have surgery other than Rotator Cuff Repair in the target arm within 180 days of treatment
  8. Subjects currently receiving radiation therapy or chemotherapy
  9. Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
  10. Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
  11. Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
  12. Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
  13. Workers' compensation patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03084068

Layout table for location information
United States, Pennsylvania
Hand & UpperEx Center
Wexford, Pennsylvania, United States, 15090
Sponsors and Collaborators
MiMedx Group, Inc.
Layout table for investigator information
Study Director: David Mason, MD MiMedx Group, Inc.
Layout table for additonal information
Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT03084068    
Other Study ID Numbers: ACORT001
First Posted: March 20, 2017    Key Record Dates
Last Update Posted: December 18, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Shoulder Injuries
Wounds and Injuries