Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

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