Integrity Implant System Post Market Clinical Follow-Up Study

Official title

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

Overview

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.

Interventions

• Device Integrity Implant System
  Integrity Implant System used for Rotator Cuff Repair

Primary outcome measures

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

Secondary outcome measures (4)

• The American Shoulder and Elbow Surgeons (ASES) Score [Time frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively]
• Constant-Murley Score (CMS) [Time frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively]
• EQ-5D-5L (EuroQol) [Time frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively]
• The Single Assessment Numeric Evaluation (SANE) Score [Time frame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively]

Eligibility criteria

• At least 18 years of age
• Able (with assistance from LAR, if necessary) to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures.
• Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
• Fully understands study requirements and able to return for all required follow-up visits and assessments.
• Able to comply with all post-operative physician prescribed rehabilitation instructions.
• Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
• Meets all intended use and indications for use defined within the Integrity Implant System IFUs as applied to rotator cuff tendon tears. These include:

Index shoulder rotator cuff tendon tear needs management and protection from injury

Index shoulder has no substantial loss of tendon tissue

Index shoulder rotator cuff tendon tear footprint allows approximation of soft tissue and fixation of the Integrity Implant to tendon tissue using an Integrity Tissue Tack

Index shoulder rotator cuff tendon tear footprint allows fixation of the Integrity Implant to bone using the Integrity Bone Staple

Exclusion criteria

The subject exclusion criteria are as follows:

• Medical condition that in the PI's opinion would place the subject at risk or interfere with the study
• 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)
• Pregnant, breastfeeding, or plans to become pregnant during the study
• History of poor compliance with medical treatment of any kind
• Deemed contraindicated for MRI by the PI
• Previous rotator cuff surgery (any type) on the index shoulder
• Current instability of the index shoulder
• Rotator cuff tendon tear is a Massive Cofield Classified Full-Thickness Tear (tear length >5cm)
• Chondromalacia of index shoulder ≥ Grade 3
• Fatty infiltration of the index shoulder rotator cuff muscle ≥ Grade 3
• Insulin dependent Type I Diabetes
• History of heavy smoking (≥ 1 pack per day) within last 6-months
• History of auto-immune or immunodeficiency disorders
• Currently taking immunosuppression medication for other diseases (e.g., transplants or other inflammatory diseases)
• Oral steroid use in the last 2-months or injectable steroid use in the last 3-months
• History of cognitive or mental health status that interferes with study participation
• Poor comprehension of English language
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 9 centers

• OrthoArizona — Gilbert
• Premier Orthopaedic Trauma Specialists, PMC — Pomona
• Foundation for Orthopaedic Research and Education — Tampa
• Harbin Clinic — Rome
• Central Indiana Orthopaedics — Fishers
• Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center — Towson
• Virtua Health — Marlton
• Steadman Hawkins Clinic of the Carolinas — Greenville
• … and 1 more center

Identifiers

NCT: NCT06741527 · Protocol 24-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗