NCT06741527

Integrity Implant System Post Market Clinical Follow-Up Study

Post Market Confirmatory Interventional Clinical Study of the Integrity Implant System Used for Rotator Cuff Tear Augmentation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Anika Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The Study Objective is to confirm the performance, safety and clinical benefit of the Integrity Implant System when used for rotator cuff tear augmentation (with or without repair). The clinical success will be evaluated by absence of rotator cuff re-tear. Performance and clinical benefits will be evaluated by functional outcomes measured using standard scoring systems such as the American Shoulder and Elbow Surgeons Shoulder Score (ASES), Constant-Murley Score (CMS), Patient Satisfaction, EQ-5D-5L, Single Assessment Numeric Evaluation (SANE), Visual Analogue Scale (VAS) and rotator cuff repair outcomes measured using MRI evaluation for repair integrity, quality, tendon tissue thickness and regeneration. Safety of the Integrity Implant System will be assessed by monitoring the frequency and incidence of adverse events. The Primary Endpoint shall confirm the Performance of the Integrity Implant System when used for rotator cuff augmentation (with or without repair). Performance will be evaluated by an adequately powered analysis of retear rates seen by MRI at 12-months after surgery.

Conditions

• Rotator Cuff Tears of the Shoulder

Interventions

Type	Name	Description
DEVICE	Integrity Implant System	Integrity Implant System used for Rotator Cuff Repair

Timeline

• Start date: 2025-02-01
• Primary completion: 2027-06-01
• Completion: 2027-10-01
• First posted: 2024-12-19
• Last updated: 2025-11-13

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study