Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Completed · Not applicable · Has a placebo group

Conditions studied: Shoulder Injury, Shoulder Sprain, Supraspinatus Tear

In brief

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.

Key facts

Study ID

NCT03084068

Run by

MiMedx Group, Inc.

People needed

25

Starts

2017-02-01

Expected to finish

2019-01-17

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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
• Subjects has used an investigational drug, device or biologic within 12 weeks prior to treatment
• Subjects who are pregnant at enrollment or are planning to become pregnant within 180 days of treatment
• Subject has any significant medical condition(s) that, in the opinion of the Investigator, would interfere with protocol evaluation and participation
• Allergy or known sensitivity to aminoglycoside antibiotics such as gentamicin sulfate and/or streptomycin sulfate
• Workers' compensation patients

Where it is running

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

Full record on ClinicalTrials.gov

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