Shoulder Injury, Shoulder Sprain, Supraspinatus Tear
Conditions
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.
Interventions
OTHERHuman dehydrated umbilical cord allograft
human dehydrated umbilical cord allograft
OTHERPlacebo
Open rotator cuff surgery with standard suture repair
Sponsors
MiMedx Group, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ASES score | 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
| Measure | Time frame | Description |
|---|---|---|
| Constant Murley Score | 12 months | Comparison of Constant scores between the two groups at each study time point |
| Shoulder range of motion | 12 months | Assessment of the change in the range of motion of the shoulder joint for both treatment groups at each study time point. |
| VAS Pain scores | 12 months | Change in patient reported pain from baseline |
| Incidence of tendon re-tear | 12 months | Incidence of supraspinatus tendon re-tear in the two treatment groups as assessed by review of MRI scans by independent radiologists |
| Incidence of adverse events | 12 months | Incidence of adverse events |
Countries
United States
Outcome results
None listed