Treatment of Partial-Thickness Rotator Cuff Tears

NCT03734536 | Terminated Results FDA Device

• 1 other identifier: REGEN.PUB.2018.09
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 10

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.

Conditions

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

Keywords

REGENETEN; REGENETEN Bioinductive Implant; highgrade partial thickness tear; rotator cuff tear; rotator cuff repair

Outcome Measures

Primary Outcomes (1)

• American Shoulder and Elbow Surgeons (ASES) Score

  American Shoulder and Elbow Surgeons (ASES) score at baseline and 3 months following index surgery. ASES is composed of 2 sections containing participant self-reported and clinician assessments. The ASES score is a 0 to 100-point rating based solely on participant responses and is a combination of the participant's shoulder pain rating (VAS Pain) and self-reported ability to perform 10 different activities of daily living (ADLs). A higher score is a better outcome.

  Baseline and 3 months

Secondary Outcomes (32)

• American Shoulder and Elbow Surgeons (ASES) Score Weekly Through 3 Months Post-Index Surgery

  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

• Single Assessment Numeric Value (SANE) Score Weekly Through 3 Months Post-Index Surgery

  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

• American Shoulder and Elbow Surgeons Visual Analog Scale (ASES-VAS) Pain Score Weekly Through 3 Months Post-Index Surgery

  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

• American Shoulder and Elbow Surgeons (ASES) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months

  Baseline, 6 months, 12 months, 18 months and 24 months

• Single Assessment Numeric Value (SANE) Score at Baseline, 6 Months, 12 Months, 18 Months and 24 Months

  Baseline, 6 months, 12 months, 18 months and 24 months

Study Arms (2)

REGENETEN™ Bioinductive Implant

OTHER

Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.

Device: REGENETEN™ Bioinductive Implant

Arthroscopic repair of the high-grade (>50%) partial-thickness

OTHER

Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Device: Arthroscopic repair of the high-grade (>50%) partial-thickness

Interventions

REGENETEN™ Bioinductive Implant DEVICE

The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.

REGENETEN™ Bioinductive Implant

Arthroscopic repair of the high-grade (>50%) partial-thickness DEVICE

Surgical treatment of partial-thickness rotator cuff tears using standard techniques.

Arthroscopic repair of the high-grade (>50%) partial-thickness

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Smith & Nephew, Inc.: lead
• Global Research Solutions: collaborator
• Medical Metrics Diagnostics, Inc: collaborator

Study Sites (10)

University of Florida Orthopaedics and Sports Medicine

Gainesville, Florida, 32607, United States

Location

Baptist Health

Jacksonville Beach, Florida, 32250, United States

Location

Harbin Clinic

Rome, Georgia, 30165, United States

Location

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Ochsner Health Center

New Orleans, Louisiana, 70121, United States

Location

Anne Arundel Medical Center/Luminis Health

Annapolis, Maryland, 21401, United States

Location

Syracuse Orthopedic Specialist

DeWitt, New York, 13214, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Orthopedic Associates of SW Ohio

Centerville, Ohio, 45459, United States

Location

Texas Orthopedic Specialists

Bedford, Texas, 76021, United States

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Limitations and Caveats

1. Study terminated due to patient selection bias (age, tear severity). 2. Low patient diary completion compliance (pain medication, for-cause imaging). 3. Unreliable MRI data (ex: tendon fill-in, tendon differentiation, tendon thickness) provided by independent reviewer.

Results Point of Contact

• Title: Samantha Andrews
• Organization: Smith+Nephew

samantha.andrews@smith-nephew.com

9789718990

Study Officials

• Howard Harris

  Texas Orthopedic Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2018
• First Posted: November 8, 2018
• Study Start: December 5, 2018
• Primary Completion: September 11, 2023
• Study Completion: September 11, 2023
• Last Updated: November 19, 2024
• Results First Posted: November 19, 2024

Record last verified: 2023-10

Locations

US (10)