Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

NCT03084068 | Completed

• 1 other identifier: ACORT001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Injury; Shoulder Sprain; Supraspinatus Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Constant Murley Score

  12 months

• Shoulder range of motion

  12 months

• VAS Pain scores

  12 months

• Incidence of tendon re-tear

  12 months

• Incidence of adverse events

  12 months

Study Arms (2)

Human umbilical cord allograft

EXPERIMENTAL

Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft

Other: Human dehydrated umbilical cord allograft

Placebo Control

PLACEBO COMPARATOR

Open Rotator Cuff Repair with standard suture repair

Other: Placebo

Interventions

Human dehydrated umbilical cord allograft OTHER

human dehydrated umbilical cord allograft

Human umbilical cord allograft

Placebo OTHER

Open rotator cuff surgery with standard suture repair

Placebo Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects who meet ANY of the following criteria will be excluded from the study:
• Shoulder pain primarily attributed to any of the following:
• Ligament rupture due to use of fluoroquinolones
• Capsular tear
• Fracture of the humeral head
• Inflammation of the joint or surrounding tissue (i.e. osteoarthritis, bursitis)
• Neuropathic, radiating pain from conditions resulting in damage or inflammation of the nerve
• Previous history of autoimmune connective tissue disorders (i.e. rheumatoid arthritis, systemic lupus erythematosus)
• Known history of poor compliance with medical treatments
• Subject has bilateral supraspinatus tendon tear
• Subject has signs and symptoms of an active infection of the shoulder joint
• Retraction of the supraspinatus tendon exceeding 1.5 cm in length
• Subject has additional injuries requiring further surgical intervention to the ipsilateral arm
• 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
• Subjects currently receiving radiation therapy or chemotherapy

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (1)

Hand & UpperEx Center

Wexford, Pennsylvania, 15090, United States

Location

MeSH Terms

Conditions

Shoulder Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• David Mason, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2017
• First Posted: March 20, 2017
• Study Start: February 1, 2017
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: December 18, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)