Treatment of Partial-Thickness Rotator Cuff Tears

Stopped early · Not applicable

Conditions studied: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness

In brief

The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (\>50%) partial-thickness tears.

Key facts

Study ID

NCT03734536

Run by

Smith & Nephew, Inc.

People needed

168

Starts

2018-12-05

Expected to finish

2023-09-11

Last updated by the study team

2024-11-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients will be considered qualified for enrollment if they meet the following criteria:
• Male or female ≥18 years
• High-grade (>50% tendon thickness) partial-thickness tear
• Failed conservative medical management of the tendon tear defined as:
• Four (4) to six (6) weeks of formal physical therapy or guided home exercises
• Activity modification
• Shoulder injection at the discretion of the surgeon
• Able to comply with the post-operative physiotherapy and follow-up schedule
• Able to speak and read English Provide written informed consent

You may not qualify if…

• Any one (1) of the following criteria will disqualify a patient from participation in the study:
• Prior shoulder surgery on index shoulder within 12 months of enrollment
• Failed primary rotator cuff surgery of the index shoulder
• On steroids within 1 month of enrollment
• Metastatic disease
• Concomitant surgeries for bone defects requiring bone implantation (Latarjet procedures) or for superior labral tear from anterior to posterior (SLAP)
• Concomitant biceps tenodesis
• Rheumatoid arthritis
• Advanced osteoarthritis
• Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
• Chronic pain disorders (i.e., fibromyalgia)
• History of insulin dependent diabetes
• History of heavy smoking (> 1 pack per day) within 6 months of enrollment
• Currently involved in any injury litigation or workers compensation claims
• Hypersensitivity to bovine-derived materials Medical or physical condition that, in the opinion of the Investigator, would preclude safe participation in the study

Where it is running

• 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

Full record on ClinicalTrials.gov

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