Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

A Prospective, Randomized Controlled Trial for Rotator Cuff Repair - Efficacy of Supraspinatus Tendon Repair Using a Human Dehydrated Umbilical Cord Patch

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.

Study Overview

• Status: Completed
• Conditions: Shoulder Injury; Supraspinatus Tear; Shoulder Sprain
• Intervention / Treatment: Other: Human dehydrated umbilical cord allograft; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Wexford, Pennsylvania, United States, 15090
      • Hand & UpperEx Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES score	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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Constant Murley Score	Comparison of Constant scores between the two groups at each study time point	12 months
Shoulder range of motion	Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point.	12 months
VAS Pain scores	Change in patient reported pain from baseline	12 months
Incidence of tendon re-tear	Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists	12 months
Incidence of adverse events	Incidence of adverse events	12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2017
• Primary Completion (ACTUAL): January 17, 2019
• Study Completion (ACTUAL): January 17, 2019

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (ACTUAL): March 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 18, 2019
• Last Update Submitted That Met QC Criteria: December 17, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Shoulder Injuries
• Other Study ID Numbers: ACORT001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No