N/A
N=106
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
Rotator Cuff Tears · Rotator Cuff Injuries
Bottom Line
View on ClinicalTrials.gov: NCT05690776 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcome: Primary: Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) — 105; 1 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) |
105; 1 | — |
| SECONDARY Constant and Murley Score |
67.9 | <0.0001 sig |
| SECONDARY EQ-5D-5L Score |
0.95 | <0.0001 sig |
| SECONDARY Assessment of Safety |
9; 97 | — |
| SECONDARY Subjective Shoulder Value |
86.1 | <0.0001 sig |
| SECONDARY Pain / Anti-Inflammatory Medication |
1; 6; 1; 98; 0; 4 | — |
| SECONDARY Patient Satisfaction |
76; 21; 7; 2 | — |
| SECONDARY Would The Patient Have This Surgery Again? |
85; 21 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT05690776). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.