PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband

Rotator Cuff Tears Clinical Trial

Official title:

Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05690776
• Other study ID #: CME2021-24SM
• Status: Recruiting
• Start date: June 17, 2022
• Est. completion date: September 1, 2024

Study information

• Verified date: January 2024
• Source: Zimmer Biomet
• Contact: Julie Nicoux
• Phone: 0672613502
• Email: julie.nicoux[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 109
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Injuries
• Rotator Cuff Tears

Locations

Country	Name	City	State
France	Ortheo	Saint-Étienne
France	Centre Clinical	Soyaux

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From operation to study completion, 0-1 year
Secondary	Constant and Murley Score	Assessment of clinical benefits by functional outcomes measured using standard scoring systems. The Constant and Murley score is a 100-point functional shoulder assessment tool in which higher scores reflect increased function. The subjective variables are pain (15 points) and function (activities of daily living - sleep, work, recreation/sport; 20 points), for a total of 35 points. The objective variables are active range of motion (clinician assessment; 40 points) and strength (25 points), for a total of 65 points.	From operation to study completion, 0-1 year
Secondary	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	From operation to study completion, 0-1 year
Secondary	Assessment of safety	Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events	From operation to study completion, 0-1 year