Study Results
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View full resultsBasic Information
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TERMINATED
NA
168 participants
INTERVENTIONAL
2018-12-05
2023-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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REGENETEN™ Bioinductive Implant
Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
REGENETEN™ Bioinductive Implant
The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
Arthroscopic repair of the high-grade (>50%) partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Arthroscopic repair of the high-grade (>50%) partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Interventions
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REGENETEN™ Bioinductive Implant
The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
Arthroscopic repair of the high-grade (>50%) partial-thickness
Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
Eligibility Criteria
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Inclusion Criteria
1. Male or female ≥18 years
2. High-grade (\>50% tendon thickness) partial-thickness tear
3. Failed conservative medical management of the tendon tear defined as:
1. Four (4) to six (6) weeks of formal physical therapy or guided home exercises
2. Activity modification
3. Shoulder injection at the discretion of the surgeon
4. Able to comply with the post-operative physiotherapy and follow-up schedule
5. Able to speak and read English Provide written informed consent
Exclusion Criteria
1. Prior shoulder surgery on index shoulder within 12 months of enrollment
2. Failed primary rotator cuff surgery of the index shoulder
3. On steroids within 1 month of enrollment
4. Metastatic disease
5. Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
6. Concomitant biceps tenodesis
7. Rheumatoid arthritis
8. Advanced osteoarthritis
9. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
10. Chronic pain disorders (i.e., fibromyalgia)
11. History of insulin dependent diabetes
12. History of heavy smoking (\> 1 pack per day) within 6 months of enrollment
13. Currently involved in any injury litigation or workers compensation claims
14. Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study
18 Years
ALL
No
Sponsors
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Global Research Solutions
INDUSTRY
Medical Metrics Diagnostics, Inc
INDUSTRY
Smith & Nephew, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Howard Harris
Role: PRINCIPAL_INVESTIGATOR
Texas Orthopedic Specialists
Locations
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University of Florida Orthopaedics and Sports Medicine
Gainesville, Florida, United States
Baptist Health
Jacksonville Beach, Florida, United States
Harbin Clinic
Rome, Georgia, United States
University of Kentucky
Lexington, Kentucky, United States
Ochsner Health Center
New Orleans, Louisiana, United States
Anne Arundel Medical Center/Luminis Health
Annapolis, Maryland, United States
Syracuse Orthopedic Specialist
DeWitt, New York, United States
Columbia University
New York, New York, United States
Orthopedic Associates of SW Ohio
Centerville, Ohio, United States
Texas Orthopedic Specialists
Bedford, Texas, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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REGEN.PUB.2018.09
Identifier Type: -
Identifier Source: org_study_id
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