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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Human umbilical cord allograft | Experimental | Open Rotator Cuff Repair patched with human dehydrated umbilical cord allograft |
|
| Placebo Control | Placebo Comparator | Open Rotator Cuff Repair with standard suture repair |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human dehydrated umbilical cord allograft | Other | human dehydrated umbilical cord allograft |
|
| 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 |
| 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. |
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Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| David Mason, MD | MiMedx Group, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hand & UpperEx Center | Wexford | Pennsylvania | 15090 | United States |
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| ID | Term |
|---|---|
| D000070599 | Shoulder Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| Placebo | Other | Open rotator cuff surgery with standard suture repair |
|
| 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 |