Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

• ClinicalTrials.gov Identifier: NCT03084068
• Recruitment Status: Completed
• First Posted: March 20, 2017
• Last Update Posted: December 18, 2019
• Sponsor: MiMedx Group, Inc.
• Information provided by (Responsible Party): MiMedx Group, Inc.

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

United States, Pennsylvania

Hand & UpperEx Center

Wexford, Pennsylvania, United States, 15090

Sponsors and Collaborators

MiMedx Group, Inc.

Investigators

• Study Director: David Mason, MD; MiMedx Group, Inc.

More Information

• Responsible Party: MiMedx Group, Inc.
• ClinicalTrials.gov Identifier: NCT03084068
• Other Study ID Numbers: ACORT001
• First Posted: March 20, 2017
• Last Update Posted: December 18, 2019
• Last Verified: December 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shoulder Injuries; Wounds and Injuries