Use of Human Dehydrated Umbilical Cord Allograft in Supraspinatus Tendon Repair

Study Overview
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Brief Summary
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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.

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

Conditions
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Shoulder Injury, Shoulder Sprain, Supraspinatus Tear

Intervention / Treatment
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* Other: Human dehydrated umbilical cord allograft
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Human umbilical cord allograft<br>Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft | Other: Human dehydrated umbilical cord allograft<br>* human dehydrated umbilical cord allograft<br>|
| Placebo Comparator: Placebo Control<br>Open Rotator Cuff Repair with standard suture repair | Other: Placebo<br>* Open rotator cuff surgery with standard suture repair<br>|

What is the study measuring?
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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 |