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
Qualifiers
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
Treatments tested in this trial
- Integrity Implant System
Treatment groups
150 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov