Integrity Implant System Post Market Clinical Follow-Up Study

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Anika Therapeutics, Inc.
Study ID
NCT06741527
Status
Recruiting
Apply to this trial

Conditions

  • Rotator Cuff Tears of the Shoulder

Eligibility Criteria

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

Interventions

  • Integrity Implant System — DEVICE
    Integrity Implant System used for Rotator Cuff Repair

Study Details

The study design is a prospective, multi-center, single-arm, non-randomized post market clinical follow-up study to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair).

Key Dates

First listed
Dec 19, 2024
Start date
Feb 1, 2025
Status verified
Jun 2026
Primary completion
Jun 30, 2027
Completion
Oct 31, 2027

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Integrity Implant System

Primary Outcome Measure

Re-tear rate after rotator cuff augmentation [ Time Frame: 12 months postoperatively ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
OrthoArizonaGilbertArizona85234
Robert Wallace
[email protected]
800-774-1534
Audrey Fierro
[email protected]
800-774-1534
Kipling Sharpe, MD (PRINCIPAL_INVESTIGATOR)
Keith Jarbo, MD (SUB_INVESTIGATOR)
Cory Nelson, MD (SUB_INVESTIGATOR)
Premier Orthopaedic Trauma Specialists, PMCPomonaCalifornia91767
Joseph Liu
[email protected]
909-596-4346
Joseph N Liu, MD (PRINCIPAL_INVESTIGATOR)
Nirav Amin, MD (SUB_INVESTIGATOR)
Foundation for Orthopaedic Research and EducationTampaFlorida33607
Debbi Warren, RN
[email protected]
844-944-4263
Peter Simon, PhD
[email protected]
844-044-4263
Christopher Baker, MD (PRINCIPAL_INVESTIGATOR)
Harbin ClinicRomeGeorgia30165
Terri Brannon
[email protected]
762-235-2612
Brandon Bushnell, MD (PRINCIPAL_INVESTIGATOR)
Central Indiana OrthopaedicsFishersIndiana46037
Brad Crackel, ATC
[email protected]
317-773-4301
Derek Yocum, PhD
[email protected]
574-247-9441
Brian Badman, MD (PRINCIPAL_INVESTIGATOR)
Aaron Baessler, MD (SUB_INVESTIGATOR)
Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical CenterTowsonMaryland21204
Debbie Codd
[email protected]
410-218-4499
Timothy Codd, MD (PRINCIPAL_INVESTIGATOR)
Virtua HealthMarltonNew Jersey08053
Donna Hoopes
[email protected]
856-355-1206
Kristin Broderick
[email protected]
856-355-1225
Sean McMillan, DO (PRINCIPAL_INVESTIGATOR)
Steadman Hawkins Clinic of the CarolinasGreenvilleSouth Carolina29615
Allison Nall, MS
[email protected]
864-454-7458
Allyson Sandago
[email protected]
864-454-7458
Stephan G Pill, MD (PRINCIPAL_INVESTIGATOR)
Campbell ClinicGermantownTennessee38138
Lucy Del Mar, MD
[email protected]
901-759-5495
Margaret Knack, RN
[email protected]
901-759-5413
Thomas W Throckmorton, MD (PRINCIPAL_INVESTIGATOR)

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