Treatment of Partial-Thickness Rotator Cuff Tears (REGEN PUB 2018)

Prospective Multi-center Study Comparing REGENETEN in Lieu of Standard Arthroscopic Repair of High-grade (>50%) Partial-thickness Tears

Demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears because REGENETEN preserves more of the native tendon footprint resulting in less postoperative pain and faster recovery.

Study Overview

• Status: Terminated
• Conditions: Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
• Intervention / Treatment: Device: REGENETEN™ Bioinductive Implant; Device: Arthroscopic repair of the high-grade (>50%) partialthickness

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.

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32607
      • University of Florida Orthopaedics and Sports Medicine
    • Jacksonville Beach, Florida, United States, 32250
      • Baptist Health
  • Georgia
    • Rome, Georgia, United States, 30165
      • Harbin Clinic
  • Kentucky
    • Lexington, Kentucky, United States, 40506
      • University of Kentucky
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Health Center
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Anne Arundel Medical Center/Luminis Health
  • New York
    • DeWitt, New York, United States, 13214
      • Syracuse Orthopedic Specialist
    • New York, New York, United States, 10032
      • Columbia University
  • Ohio
    • Centerville, Ohio, United States, 45459
      • Orthopedic Associates of SW Ohio
  • Texas
    • Bedford, Texas, United States, 76021
      • Texas Orthopedic Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: REGENETEN™ Bioinductive Implant; Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.	Device: REGENETEN™ Bioinductive Implant; The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
Other: Arthroscopic repair of the high-grade (>50%) partialthickness; Surgical treatment of partial-thickness rotator cuff tears using standard techniques.	Device: Arthroscopic repair of the high-grade (>50%) partialthickness; Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
ASES (American Shoulder and Elbow Surgeons) score tear using standard surgical techniques.	at 3 months following index surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ASES score		over initial 3 months following index surgery
Single Assessment Numeric Value (SANE) score		over initial 3 months following index surgery
ASES Visual Analog Scale (VAS) pain score		over initial 3 months following index surgery
ASES score		at 6, 12, 18 and 24 months following index surgery
SANE score		at 6, 12, 18 and 24 months following index surgery
ASES VAS pain score		at 6, 12, 18 and 24 months following index surgery
Shoulder Stiffness Visual Analog Scale (VAS) score	Stiffness in the participant's index shoulder will be assessed using the shoulder stiffness VAS. The VAS is a continuous scale comprised of a horizontal line 100 millimeters (mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme: No Stiffness (0 mm) and Extreme Stiffness (100 mm). The VAS stiffness rating will be recorded pre-operatively, weekly from 1 week to 3 months post-surgery, and at 6 and 12 months post-surgery.	over 12 months following index surgery
Cumulative opioid use to treat the index shoulder		over 12 months following index surgery
Cumulative non-opioid prescription medication use to treat the index shoulder		over 12 months following index surgery
Duration of shoulder immobilization		following index surgery
Time to return to activities of daily living (ADLs) o Return to work by work type (sedentary; laborer) o Return to driving o Return to sports		following index surgery
Incidence of progression to full-thickness tear		within 12 months following index surgery
Incidence of progression to full-thickness tear		within 24 months following index surgery
Incidence of revision surgery (index shoulder; all causes)		within 24 months following index surgery
Aggregate health care utilization costs		over 12 months following index surgery
Operating room time (index surgery)		Intra-operative
Number of steroid injections		over 12 months following index surgery
Number of unscheduled clinic visits		over 12 months following index surgery
Number of for-cause imaging procedures		over 12 months following index surgery

Collaborators and Investigators

• Sponsor: Smith & Nephew, Inc.
• Collaborators: Medical Metrics Diagnostics, Inc; Global Research Solutions
• Investigators: Principal Investigator: Howard Harris, Texas Orthopedic Specialists

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2018
• Primary Completion (Actual): September 11, 2023
• Study Completion (Actual): September 11, 2023

Study Registration Dates

• First Submitted: November 6, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 18, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: rotator cuff tear; rotator cuff repair; REGENETEN; REGENETEN Bioinductive Implant; highgrade partial thickness tear
• Additional Relevant MeSH Terms: Wounds and Injuries; Rupture; Shoulder Injuries; Tendon Injuries; Rotator Cuff Injuries
• Other Study ID Numbers: REGEN.PUB.2018.09

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes