Use of the REGENETEN™ Bioinductive Implant System in High Grade Partial-thickness Tears

Part of paid clinical trials in Rome, Georgia.

Sponsor
Smith & Nephew, Inc.
Study ID
NCT05444465
Status
Recruiting
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Conditions

  • Rotator Cuff Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Isolated Bioinductive Repair — DEVICE
    Isolated Bioinductive repair with REGENETEN™ Bioinductive Implant
  • Completion and Repair — PROCEDURE
    Standard surgical repair using the 'Completion and Repair' technique.

Study Details

The purpose of the study is to assess whether the REGENETEN™ Bioinductive Implant allows patients to get back to their everyday activities quicker than if the tendon is repaired by the standard repair technique 'Completion and Repair' for surgically treating partial-thickness rotator cuff tears.

Key Dates

Start date
Aug 30, 2022
Status verified
Dec 2025
Primary completion
Aug 15, 2026
Completion
Jun 30, 2028

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Isolated Bioinductive Repair
    Surgical treatment of partial-thickness rotator cuff tears with the REGENETEN Bioinductive Implant system.
  • Active Comparator: Completion and Repair
    Surgical treatment of partial-thickness rotator cuff tears using the standard surgical technique 'Completion and Repair'.

Primary Outcome Measure

Change in Western Ontario Rotator Cuff (WORC) [ Time Frame: Change from baseline to 3 months post-intervention ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Harbin ClinicRomeGeorgia30165
Terri Brannon
Brandon Bushnell (PRINCIPAL_INVESTIGATOR)
OrthoIllinois LTDRockfordIllinois61107
Catherine Ayala
Scott Trenhaile (PRINCIPAL_INVESTIGATOR)
Sinai Hospital BaltimoreBaltimoreMaryland21215-
Cleveland Clinic - Sports HealthGarfield HeightsOhio44125-
University of PittsburghPittsburghPennsylvania15213
Alec Howard
Albert Lin (PRINCIPAL_INVESTIGATOR)
Texas Orthopedic SpecialistsBedfordTexas76021
Amber Morgan
Howard Harris (PRINCIPAL_INVESTIGATOR)
Houston Methodist The WoodlandsThe WoodlandsTexas77385-
Memorial Medical CenterAshlandWisconsin54806-

Find similar trials in Rome, GA

By research site
Harbin Clinic· Rome, GAOrthoIllinois LTD· Rockford, ILSinai Hospital Baltimore· Baltimore, MDCleveland Clinic - Sports Health· Garfield Heights, OHUniversity of Pittsburgh· Pittsburgh, PATexas Orthopedic Specialists· Bedford, TX

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