Rotator Cuff TearsNCT05690776
PMCF Study on the Safety, Performance and Clinical Benefits Data of the Quattro X Broadband
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Zimmer Biomet at 2 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tears, Rotator Cuff Injuries
- How many people
- 106 participants
- Where
- 2 sitesFrance
- Study dates
- 17 Jun 2022to 15 Nov 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)
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.
Read the 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.
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients who received the Quattro X BroadBand | No specific interventions will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From operation to study completion, 0-1 year
Secondary outcomes (7)
Constant and Murley Score
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. The minimum score is 0 points (worst outcome), the maximum score possible is 100 points (best outcome).
Measured: From operation to study completion, 0-1 year
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. In the derived EQ-5D-5L score, the highest score is 1 (best outcome) and the lowest score is -0.573 (worst outcome).
Measured: From operation to study completion, 0-1 year
Assessment of Safety
Safety will be assessed by monitoring the incidence and frequency of device and/or procedure related adverse events
Measured: From operation to study completion, 0-1 year
Subjective Shoulder Value
The Subjective Shoulder Value is a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder.
Measured: From operation to study completion, 0-1 year
Pain / Anti-Inflammatory Medication
Does The Patient Take Pain/Anti-Inflammatory Medication?
Measured: 1 year after surgery
Patient Satisfaction
Patient satisfaction was assessed 1 year after surgery. Possible answers were: very satisfied, satisfied, somewhat satisfied, disappointed.
Measured: 1 year after surgery
Would The Patient Have This Surgery Again?
1 year after their surgery, patients were asked if yes or no they would have the surgery again.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2023
- Study start17 Jun 2022
- Primary completion9 Aug 2024
- Study completion15 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Rotator Cuff TearsStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan Achakri, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05690776
- Sponsor's protocol ID
- CME2021-24SM
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2022
- Last updated
- 10 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quattro® X Suture Anchor With BroadBand™ Tape Post Market Clinical Follow-up Study (Incl. Instruments)
- ClinicalTrials.gov ID
- NCT05690776
- Acronym / sponsor ID
- CME2021-24SM
- Conditions
- Rotator Cuff Tears, Rotator Cuff Injuries
- Keywords
- Post-Market Clinical Follow-Up Study, Medical Device, Performance, Safety, Clinical Benefits
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 17 Jun 2022 (actual)
- Primary completion
- 9 Aug 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 19 Jan 2023 (actual)
- Results
- Posted 10 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who received the Quattro X BroadBand | – | –No specific interventions will be administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff)
Time frame: From operation to study completion, 0-1 year
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.
7 secondary outcomes
Constant and Murley Score
Time frame: From operation to study completion, 0-1 year
EQ-5D-5L Score
Time frame: From operation to study completion, 0-1 year
Assessment of Safety
Time frame: From operation to study completion, 0-1 year
Subjective Shoulder Value
Time frame: From operation to study completion, 0-1 year
Pain / Anti-Inflammatory Medication
Time frame: 1 year after surgery
Patient Satisfaction
Time frame: 1 year after surgery
Would The Patient Have This Surgery Again?
Time frame: 1 year after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hassan Achakri study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotator Cuff Tears and Rotator Cuff Injuries, run by Zimmer Biomet at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Performance by Analyzing Soft Tissue to Bone Healing in the Shoulder (Rotator Cuff) (time frame: From operation to study completion, 0-1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.