Rotator Cuff Tears of the Shoulder
Conditions
Keywords
Rotator Cuff Repair, Shoulder repair, Integrity Implant
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.
Interventions
DEVICEIntegrity Implant System
Integrity Implant System used for Rotator Cuff Repair
Sponsors
Anika Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
CONTACTKara Mezger
CONTACTJennifer Williams
Outcome results
None listed