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
This trial does not accept healthy volunteersQualifiers
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 population
Subjects must have been treated with the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding for rotator cuff repair.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
43 Participants
are grouped into 1 trial groupGroup A: Patients who received the ComposiTCP Suture Anchors Double Loaded with BroadBand Tape, Sliding
Trial outcomes
Primary outcomes
1
Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff)
The investigator will clinically evaluate at 1 year follow-up visit if soft tissue to bone healing has occurred by the absence of device-related revisions and re-tears that were not previously reported. The following question will be asked to the investigator: "Did soft tissue to bone healing occur"? If "yes" is answered, then the soft tissue to bone healing is successful, if "no" is answered, then the soft tissue to bone healing is considered unsuccessful.
Time frame
From operation to study completion, 0-1 yearSecondary outcomes
1
EQ-5D-5L Score
Assessment of clinical benefits by functional outcomes measured using standard scoring systems. The EQ-5D measures 5 dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, with a total of 5 questions. It is accompanied by the patient's self-assessment with the VAS. Each dimension is assigned one of three discrete levels for evaluation on the day of administration: Level 1 - No problems, no disability Level 2 - Some problems, moderate disability Level 3 - A lot of problems, severe disability The final score is a five digit composite of the responses ranging between 33333 - 11111 with 243 possible combinations in between
Time frame
From operation to study completion, 0-1 year2
The incidence and frequency of device and/or procedure related adverse events
Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events
Time frame
From operation to study completion, 0-1 year3
Oxford Shoulder Score
The OSS is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TSA. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 5 (worst outcome) to 0 (best outcome) and the sum of all 12 items is reported with a maximum of 60, representing the worst score possible.
Time frame
From surgery until study completion, 0-1 yearSponsors and contacts
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Source ClinicalTrials.gov