Integrity Implant System Post Market Clinical Follow-Up Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2027-10-31

Brief Summary

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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

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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

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Rotator Cuff Tears of the Shoulder

Keywords

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Rotator Cuff Repair Shoulder repair Integrity Implant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

1. Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
2. Vulnerable population (prisoners, minors, pregnant women, mentally ill persons and the elderly or any person under any undue pressure from others to participate in the study)
3. Pregnant, breastfeeding, or plans to become pregnant during the study
4. History of poor compliance with medical treatment of any kind
5. Deemed contraindicated for MRI by the PI
6. Previous rotator cuff surgery (any type) on the index shoulder
7. Current instability of the index shoulder
8. Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length \>5cm)
9. Chondromalacia of index shoulder ≥ Grade 3
10. Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
11. Insulin dependent Type I Diabetes
12. History of heavy smoking (≥ 1 pack per day) within last 6-months
13. History of auto-immune or immunodeficiency disorders
14. Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
15. Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
16. History of cognitive or mental health status that interferes with study participation
17. Poor comprehension of English language
18. Meets one or more of the contraindications defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:

18.1 Rotator cuff tendon tear is deemed irreparable by the PI

18.2 Rotator cuff tendon tear repair requires replacement of damaged tendon

18.3 Rotator cuff tendon tear repair requires fixation of soft tissue to adjoining soft tissue

18.4 Rotator cuff tendon tear repair requires tendon strength reinforcement

18.5 Presence of infection

18.6 Any condition which would limit the ability or willingness to restrict activities or follow directions during the healing period

18.7 Hypersensitivity to any of the Integrity Implant System components

18.8 Inadequate soft tissue support for Integrity Tissue Tack fixation

18.9 Inadequate quality of bone for Integrity Bone Staple fixation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

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Kara Mezger

Role: CONTACT

Phone: 7657710026

Email: [email protected]

Jennifer Williams

Role: CONTACT

Phone: 781-457-9000

Identifier Type: -

Identifier Source: org_study_id