Integrity Implant System Post Market Clinical Follow-Up Study

Phase 4

Recruiting

• Conditions: Rotator Cuff Tears of the Shoulder

• Registration Number: NCT06741527
• Lead Sponsor: Anika Therapeutics, Inc.

Brief 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.

Study Timeline

• Status Verified: 2024-12
• Study First Submitted: 2024-12-15
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-19
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-28
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-06
• Study Completion: 2027-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Re-tear rate after rotator cuff augmentation	12 months postoperatively	Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.

Secondary Outcome Measures

Name	Time	Method
The American Shoulder and Elbow Surgeons (ASES) Score	Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively	The American Shoulder and Elbow Surgeon's (ASES) Score is a tool used to measure shoulder function. The ASES score is on a scale of 0 to 100, with 0 being the worst possible score and 100 the best. The score consists of two components - pain and activities of daily living.
Constant-Murley Score (CMS)	Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively	The Constant-Murley Shoulder Score is a scoring method used by clinicians to assess function of the shoulder. The standard score is on a scale of 0 to 100, with 0 being no shoulder function and 100 being excellent function.
EQ-5D-5L (EuroQol)	Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively	The 5-level EQ-5D (EQ-5D-5L) is a standardized self-assessed, health related quality of life questionnaire. It is composed of five questions with Likert scale response options (descriptive system) and a visual analog scale (EQ-VAS). The EQ-VAS asks patients to rate their own health from 0 to 100 (the worst and best imaginable health, respectively).
The Single Assessment Numeric Evaluation (SANE) Score	Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively	The Single Assessment Numeric Evaluation (SANE) Score is a tool used to assess the subject's perception of their affected joint. Participants are requested to rate their shoulder function on a scale of 0 to 100, with 0 as the worst option and 100 being normal shoulder function.

Trial Locations

Locations (7)

Foundation for Orthopaedic Research and Education; 🇺🇸 Tampa, Florida, United States

Central Indiana Orthopaedics; 🇺🇸 Fishers, Indiana, United States

Steadman Hawkins Clinic of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center; 🇺🇸 Towson, Maryland, United States

Virtua Health; 🇺🇸 Marlton, New Jersey, United States

Campbell Clinic; 🇺🇸 Germantown, Tennessee, United States