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

NCT05690776 | Completed Results

• 1 other identifier: CME2021-24SM
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 2

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.

Conditions

Rotator Cuff Tears; Rotator Cuff Injuries

Keywords

Post-Market Clinical Follow-Up Study; Medical Device; Performance; Safety; Clinical Benefits

Outcome Measures

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.

  From operation to study completion, 0-1 year

Secondary Outcomes (7)

• Constant and Murley Score

  From operation to study completion, 0-1 year

• EQ-5D-5L Score

  From operation to study completion, 0-1 year

• Assessment of Safety

  From operation to study completion, 0-1 year

• Subjective Shoulder Value

  From operation to study completion, 0-1 year

• Pain / Anti-Inflammatory Medication

  1 year after surgery

Study Arms (1)

Patients who received the Quattro X BroadBand

No specific interventions will be administered.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Subject treated with the Quattro® X Suture Anchor with BroadBand™ Tape for rotator cuff repair;
• Older than 18 years 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;
• Subject is able to read and understand the ICF and has voluntarily provided written informed consent.

You may not qualify if:

• Presence of infection;
• Insufficient or immature bone;
• Insufficient blood supply or previous infections which may hinder the healing process;
• Foreign body sensitivity;
• 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);
• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Ortheo

Saint-Etienne, 42100, France

Location

Centre Clinical

Soyaux, 16800, France

Location

MeSH Terms

Conditions

Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Results Point of Contact

• Title: Julie Nicoux
• Organization: Zimmer Biomet

julie.nicoux@zimmerbiomet.com

+33672613502

Study Officials

• Hassan Achakri

  Zimmer Biomet

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 19, 2023
• Study Start: June 17, 2022
• Primary Completion: August 9, 2024
• Study Completion: November 15, 2024
• Last Updated: September 10, 2025
• Results First Posted: September 10, 2025

Record last verified: 2024-12

Locations

FR (2)