Clinical trial NCT05690776: PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
Official title: Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotator Cuff Tears
Rotator Cuff Injuries
Keywords: Post-Market Clinical Follow-Up Study
Medical Device
Performance
Safety
Clinical Benefits
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2023-01-19
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair, according to the IFU and who meet all of the inclusion and none of exclusion criteria.

Brief summary: 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 Quattro® X Suture Anchor with BroadBand™ Tape and Instruments 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. Constant \& Murley 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.

Detailed description: The Quattro® X Suture Anchor with BroadBand™ Tape is intended for use in rotator cuff repairs. It is intended for for the reattachment of soft tissue to bone.

Up to three sites will be involved in this study. The aim is to include a total of 109 consecutive series cases who received the Quattro® X Suture Anchor with BroadBand™ Tape. All potential study subjects will be required to participate in the Informed Consent Process.

Baseline data from the preop, intraop and immediate post-op intervals will be available in medical notes and collected retrospectively. During follow-up visits at 1 years post-op, the patient will be asked to complete patient questionnaires. Moreover, a clinical assessment will be conducted. In addition, any complications and adverse events will also be collected during these follow-up visits.

Eligibility criteria: Inclusion Criteria:

1. Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
2. Older than 18 years and skeletally mature;
3. Willing and able to comply with the study procedures;
4. Subject is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program;
5. Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

Exclusion Criteria:

1. Presence of infection;
2. Insufficient or immature bone;
3. Insufficient blood supply or previous infections which may hinder the healing process;
4. Foreign body sensitivity;
5. Subject is vulnerable (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant);
6. The subject is unwilling or unable to give consent or to comply with the follow-up program;
7. Subject meets any contraindications of the appropriate Instruction for Use.

Primary outcomes:
measure: Assessment of performance by analyzing soft tissue to bone healing in the shoulder (rotator cuff)
timeFrame: From operation to study completion, 0-1 year
Secondary outcomes:
measure: Constant and Murley Score
timeFrame: From operation to study completion, 0-1 year
measure: EQ-5D-5L Score
timeFrame: From operation to study completion, 0-1 year
measure: Assessment of safety
timeFrame: From operation to study completion, 0-1 year
Other outcomes:
Locations:
city: Saint-Étienne
country: France
facility: Ortheo
city: Soyaux
country: France
facility: Centre Clinical
Study officials:
affiliation: Zimmer Biomet
name: Hassan Achakri
role: STUDY_DIRECTOR
References: