PMCF Study on the Safety, Performance and Clinical Benefits Data of the ComposiTCP
ConditionRotator Cuff Repairs
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorZimmer Biomet
About this trial
The study is a multicenter, retrospective and prospective, non-randomized, noncontrolled, and consecutive series post-market study. The purpose of this study is collect data confirming safety, performance and clinical benefits of the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding implants when used in rotator cuff repair.
The primary endpoint of this study is the assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff). Healing will be assessed by the investigator using PROMs and clinical outcomes of the patient.
The clinical benefit will be assessed by functional outcomes measured using standard and well-established scoring systems (e.g. Oxford Shoulder Score and EQ-5D-5L) at 1 year post-operative.
The safety will be assessed by monitoring the incidence and frequency of device- and/or procedure-related adverse events.
Eligibility criteria
Qualifiers
Subject was treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair;
At least 18 years old and skeletally mature;
Willing and able to comply with the study procedures;
Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
Disqualifiers
Subject is vulnerable (is unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response);
The subject is unwilling or unable to give consent or to comply with the follow-up program;
Subject meets any contraindications of the appropriate Instruction for Use;
Off-Label Use.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
43 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov