Treatment of Partial-Thickness Rotator Cuff Tears

Overview

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.

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 11, 2023

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.

Interventions

  • Device: REGENETEN™ Bioinductive Implant
    • The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
  • Device: Arthroscopic repair of the high-grade (>50%) partialthickness
    • Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Arms, Groups and Cohorts

  • Other: REGENETEN™ Bioinductive Implant
    • Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
  • Other: Arthroscopic repair of the high-grade (>50%) partialthickness
    • Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • ASES score
    • Time Frame: over initial 3 months following index surgery
  • Single Assessment Numeric Value (SANE) score
    • Time Frame: over initial 3 months following index surgery
  • ASES Visual Analog Scale (VAS) pain score
    • Time Frame: over initial 3 months following index surgery
  • ASES score
    • Time Frame: at 6, 12, 18 and 24 months following index surgery
  • SANE score
    • Time Frame: at 6, 12, 18 and 24 months following index surgery
  • ASES VAS pain score
    • Time Frame: at 6, 12, 18 and 24 months following index surgery
  • Shoulder Stiffness Visual Analog Scale (VAS) score
    • Time Frame: over 12 months following index surgery
    • 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.
  • Cumulative opioid use to treat the index shoulder
    • Time Frame: over 12 months following index surgery
  • Cumulative non-opioid prescription medication use to treat the index shoulder
    • Time Frame: over 12 months following index surgery
  • Duration of shoulder immobilization
    • Time Frame: 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
    • Time Frame: following index surgery
  • Incidence of progression to full-thickness tear
    • Time Frame: within 12 months following index surgery
  • Incidence of progression to full-thickness tear
    • Time Frame: within 24 months following index surgery
  • Incidence of revision surgery (index shoulder; all causes)
    • Time Frame: within 24 months following index surgery
  • Aggregate health care utilization costs
    • Time Frame: over 12 months following index surgery
  • Operating room time (index surgery)
    • Time Frame: Intra-operative
  • Number of steroid injections
    • Time Frame: over 12 months following index surgery
  • Number of unscheduled clinic visits
    • Time Frame: over 12 months following index surgery
  • Number of for-cause imaging procedures
    • Time Frame: over 12 months following index surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Smith & Nephew, Inc.
  • Collaborator
    • Global Research Solutions
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Howard Harris, Principal Investigator, Texas Orthopedic Specialists

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