Integrity Implant System Post Market Clinical Follow-Up Study
ConditionRotator Cuff Tears of the Shoulder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnika Therapeutics, Inc.
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Integrity Implant System
DeviceIntegrity Implant System used for Rotator Cuff Repair
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Integrity Implant SystemOther 1 intervention
Trial outcomes
Primary outcomes
1
Re-tear rate after rotator cuff augmentation
Assessed by MRI evaluation at 12 months post-operatively defined using Sugaya classification system.
Time frame
12 months postoperativelySecondary outcomes
1
The American Shoulder and Elbow Surgeons (ASES) Score
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.
Time frame
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month Post-operatively2
Constant-Murley Score (CMS)
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.
Time frame
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively3
EQ-5D-5L (EuroQol)
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).
Time frame
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operatively4
The Single Assessment Numeric Evaluation (SANE) Score
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.
Time frame
Screening/Pre-Op, 6 weeks, 6-month, 12-month and 24-month post-operativelySponsors and contacts
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Source ClinicalTrials.gov