Rotator Cuff InjuriesFIXIT®2018NCT05720286
Performance and Safety of the FIXIT® Anchor in Arthroscopic Rotator Cuff Repair
An observational study of Rotator Cuff Injuries, run by Science and biomaterials at 2 sites in France.
Trial summary
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Injuries
- What is being tested?
- Arthroscopic rotator cuff repair
- Type of treatment
- Medical device
- How many people
- 30 participants
- Where
- 2 sitesFrance
- Study dates
- 12 Dec 2018to 31 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: A total of 30 patients, aged between 45 to 78 and operated for a rotator cuff repair were selected in this study. Initially, 31 patients were included but 1 withdrew from the study.
Who may be able to join
- Patient with broken tendinopathy of the rotator cuff
- Patient over 18 years old
- Patient who has received complete medical information and not objecting to participate in research
- Social insured patient
Who cannot join
- Pregnant or likely to be pregnant, or breastfeeding
- Patient under guardianship
- Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices
Read the detailed description
the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification
- Conditions
- Rotator Cuff Injuries
- Being tested
- Arthroscopic rotator cuff repair
- 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.
Arthroscopic rotator cuff repairDevice
Arthroscopic transosseous reinsertion of the rotator cuff is the most widely used arthroscopic technique. The tendons are repositioned on the greater and lesser tuberosities of the humerus with specific anchors. These anchors, placed in the humeral bone, are attached to sutures which are in turn tied to the tendon.
| Study group | Role | What they receive |
|---|---|---|
| Study group | There was only one group as the study was a non-comparative study Receives: Device: Arthroscopic rotator cuff repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sugaya classification
Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff.
Measured: 1 year postoperative
Secondary outcomes (4)
Constant score
Functional score
Measured: 45 days, 5months and 1 year postoperative
Pain score
EVA pain scale
Measured: 45 days, 5months and 1 year postoperative
Quick DASH score
Capacity of shoulder score
Measured: 45 days, 5months and 1 year postoperative
Fatty degeneration
Bernageau classification
Measured: preoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start12 Dec 2018
- Primary completion14 Sep 2020
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff InjuriesStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Science and biomaterials
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas BONNEVIALLE, Pr, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720286
- Sponsor's protocol ID
- 2018-A02653-52
- Acronym
- FIXIT®2018
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verification of the Performance and Safety of the First Row Resorbable Threaded Anchor FIXIT® in Arthroscopic Rotator Cuff Repair as Part of the Post-marketing Follow-up of Device
- ClinicalTrials.gov ID
- NCT05720286
- Acronym / sponsor ID
- FIXIT®2018 / 2018-A02653-52
- Conditions
- Rotator Cuff Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Science and biomaterialsIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2018 (actual)
- Primary completion
- 14 Sep 2020 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Verification of the performance and safety of the first row resorbable threaded anchor FIXIT® in arthroscopic rotator cuff repair Non-interventional, prospective, non-comparative, multi-center study as part of the post-marketing follow-up of devices
Detailed description
the main objective of this study was to verify the safety of the resorbable threaded anchor FIXIT®, used in arthroscopic rotator cuff repair. This objective was to be imaging assessed (echography, MRI) for the presence or absence of a rotator cuff re-tear and its degree of retractation. The second objective was to verify the performance of the FIXIT® anchor with 4 scoring criteria : Constant score, pain score EVA, Quick DASH score and Bernageau classification
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Arthroscopic rotator cuff repairThere was only one group as the study was a non-comparative study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 30 patients, aged between 45 to 78 and operated for a rotator cuff repair were selected in this study. Initially, 31 patients were included but 1 withdrew from the study.
Key inclusion criteria (4 listed)
- Patient with broken tendinopathy of the rotator cuff
- Patient over 18 years old
- Patient who has received complete medical information and not objecting to participate in research
- Social insured patient
Key exclusion criteria (3 listed)
- Pregnant or likely to be pregnant, or breastfeeding
- Patient under guardianship
- Non-cooperative patient, who does not want or is unable to follow the post-operative instructions (drug addict or alcoholic patient in particular)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthroscopic rotator cuff repairArthroscopic transosseous reinsertion of the rotator cuff is the most widely used arthroscopic technique. The tendons are repositioned on the greater and lesser tuberosities of the humerus with specific anchors. These anchors, placed in the humeral bone, are attached to sutures which are in turn tied to the tendon. | Device | Study group |
Primary outcome
Sugaya classification
Time frame: 1 year postoperative
Radiological evaluation to assess the absence of rotator cuff re-tears with the Sugaya classification and the retraction's degree of the cuff.
4 secondary outcomes
Constant score
Time frame: 45 days, 5months and 1 year postoperative
Pain score
Time frame: 45 days, 5months and 1 year postoperative
Quick DASH score
Time frame: 45 days, 5months and 1 year postoperative
Fatty degeneration
Time frame: preoperative
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
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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.
Nicolas BONNEVIALLE, Pr principal investigator
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 Injuries, run by Science and biomaterials 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 4 inclusion and 3 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 9 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sugaya classification (time frame: 1 year postoperative). 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 9 Feb 2023.