Clinical trial NCT03734536: Treatment of Partial-Thickness Rotator Cuff Tears
Official title: Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Keywords: REGENETEN
REGENETEN Bioinductive Implant
highgrade partial thickness tear
rotator cuff tear
rotator cuff repair
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Global Research Solutions
name: Medical Metrics Diagnostics, Inc
First posted: 2018-11-08
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: The objective of this study is to demonstrate arthroscopic surgical treatment of high-grade (\>50%) partial-thickness tears using REGENETEN yields statistically superior patient post-operative recovery outcomes, faster return to activities of daily living, and less health care utilization versus standard surgical repair techniques.

Eligibility criteria: Inclusion Criteria:

Patients will be considered qualified for enrollment if they meet the following 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:

Any one (1) of the following criteria will disqualify a patient from participation in the study:

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

Primary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery
timeFrame: Baseline, Week 1, Week 2,Week 3,Week 4,Week 5,Week 6,Week 7,Week 8,Week 9,Week 10,Week 11, & Week 12
measure: Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
measure: American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery
timeFrame: Baseline, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
measure: American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months
measure: Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months
measure: American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months
timeFrame: Baseline, 6 months, 12 months, 18 months and 24 months
measure: Constant-Murley Score at Baseline, 3 Months, 6 Months, 12 Months, and 24 Months
timeFrame: Baseline, 3 months, 6 months, 12 months, and 24 months
measure: Weekly Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
timeFrame: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
measure: Weekly Non-Opioid Use to Treat Index Shoulder Through 3 Months Post-Index Surgery
timeFrame: Directly after surgery, Week 1, Week 2, Week 3, Week 4, Week 5, Week 6, Week 7, Week 8, Week 9, Week 10, Week 11, Week 12
measure: Opioid Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
timeFrame: Directly after surgery, 6 months, and 12 months
measure: Non-Opioid Prescription Medication Use to Treat the Index Shoulder Directly After Surgery, 6 Months, and 12 Months
timeFrame: Directly after surgery, 6 months, and 12 months
measure: Duration of Shoulder Immobilization
timeFrame: Following index surgery, up to 7 weeks
measure: Number of Participants Return to Work Status by Type of Work at 12 Months Post-Index Surgery
timeFrame: Up to 12 months
measure: Time to Return to Driving
timeFrame: Following index surgery, up to 139 days
measure: Time to Return to Sports
timeFrame: Following index surgery, approximately 1 year
measure: Number of Participants With Progression to Full-Thickness Tear at 12 Months
timeFrame: 12 months
measure: Number of Participants With Progression to Full-Thickness Tear at 24 Months
timeFrame: 24 months
measure: Number of Participants Percent Filling of Rotator Cuff at 12 Months
timeFrame: 12 months
measure: Number of Participants Percent Filling of Rotator Cuff at 24 Months
timeFrame: 24 months
measure: Rotator Cuff Tendon Thickness at 12 Months
timeFrame: 12 Months
measure: Rotator Cuff Tendon Thickness at 24 Months
timeFrame: 24 Months
measure: Number of Participants Goutallier Classification of Rotator Cuff at 12 Months
timeFrame: 12 months
measure: Number of Participants Goutallier Classification of Rotator Cuff at 24 Months
timeFrame: 24 months
measure: Number of Participants Sugaya Score of Rotator Cuff at 12 Months
timeFrame: 12 months
measure: Number of Participants Sugaya Score of Rotator Cuff at 24 Months
timeFrame: 24 months
measure: Number of Participants With Revision Surgery
timeFrame: Following index surgery, up to 24 months
measure: Aggregate Health Care Utilization Costs
timeFrame: Following index surgery, up to 12 months
measure: Operating Room Time (Index Surgery)
timeFrame: Intra-operative
measure: Number of Steroid Injections
timeFrame: Following index surgery, up to 12 months
measure: Number of Unscheduled Clinic Visits
timeFrame: Following index surgery, up to 12 months
measure: Number of For-Cause Imaging Procedures
timeFrame: Following index surgery, up to 12 months
measure: Number of Physiotherapy Sessions
timeFrame: Following index surgery, up to 12 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida Orthopaedics and Sports Medicine
state: Florida
city: Jacksonville Beach
country: United States
facility: Baptist Health
state: Florida
city: Rome
country: United States
facility: Harbin Clinic
state: Georgia
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Health Center
state: Louisiana
city: Annapolis
country: United States
facility: Anne Arundel Medical Center/Luminis Health
state: Maryland
city: DeWitt
country: United States
facility: Syracuse Orthopedic Specialist
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Centerville
country: United States
facility: Orthopedic Associates of SW Ohio
state: Ohio
city: Bedford
country: United States
facility: Texas Orthopedic Specialists
state: Texas
Study officials:
affiliation: Texas Orthopedic Specialists
name: Howard Harris
role: PRINCIPAL_INVESTIGATOR
References: