Clinical trial NCT06741527: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Rotator Cuff Tears of the Shoulder
Keywords: Rotator Cuff Repair
Shoulder repair
Integrity Implant
Lead sponsor: Anika Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2024-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 1. At least 18 years of age
2. 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.
3. Able to complete all Patient Reported Outcome Measure (PROM) questionnaires.
4. Fully understands study requirements and able to return for all required follow-up visits and assessments.
5. Able to comply with all post-operative physician prescribed rehabilitation instructions.
6. Index shoulder rotator cuff tendon tear surgical access may be performed using mini-open, single-portal arthroscopic or multi-portal arthroscopic intervention
7. 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:

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

Primary outcomes:
measure: Re-tear rate after rotator cuff augmentation
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: The American Shoulder and Elbow Surgeons (ASES) Score
timeFrame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively
measure: Constant-Murley Score (CMS)
timeFrame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
measure: EQ-5D-5L (EuroQol)
timeFrame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
measure: The Single Assessment Numeric Evaluation (SANE) Score
timeFrame: Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Foundation for Orthopaedic Research and Education
state: Florida
city: Fishers
country: United States
facility: Central Indiana Orthopaedics
state: Indiana
city: Louisville
country: United States
facility: Norton Healthcare
state: Kentucky
city: Towson
country: United States
facility: Towson Orthopaedic Associates/University of Maryland St. Joseph's Medical Center
state: Maryland
city: Marlton
country: United States
facility: Virtua Health
state: New Jersey
city: Greenville
country: United States
facility: Steadman Hawkins Clinic of the Carolinas
state: South Carolina
city: Germantown
country: United States
facility: Campbell Clinic
state: Tennessee
Study officials:
References: