Clavicle FractureKATNCT07664202
Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations
A study of Clavicle Fracture, run by BOUCHRA BENKESSOU at 1 site in France.
Trial summary
This study aims to inform clinical decision-making by thoroughly examining the outcomes of different treatment approaches for lateral quarter clavicle fractures and acromioclavicular dislocations. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Clavicle Fracture
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jan 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting with a fracture of the lateral quarter of the clavicle or a severe acromioclavicular disjunction (Rockwood stages III-V) confirmed by radiological examination
- Patients who have given their consent to participate in the observational study after being informed by the surgeon
Who cannot join
- Minor patients;
- Subjects who are legally protected adults, under guardianship or trusteeship;
- Infection;
- Pregnant or breastfeeding women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Clinique Du Trocadéro
Paris, 75116
bouchra benkessou, chef de projet, 07 64 48 60 16, b.benkessou@hexagone-sante-paris.fr
Bertrand BAUER, Docteur
About this study
Official title: Prospective Study on the Interest of Using an Endobutton Under Fluoroscopic Control Alone to Treat Lateral Quarter Clavicle Fractures and Severe Acromioclavicular Dislocations
This study aims to inform clinical decision-making by thoroughly examining the outcomes of different treatment approaches for lateral quarter clavicle fractures and acromioclavicular dislocations. By evaluating the safety and efficacy of Knotless AC TightRope® repair devices and comparing short- and long-term results with other fixation techniques, the investigators hope to contribute to the improvement of treatment protocols for these common shoulder injuries. This research could significantly impact patients' quality of life by enabling optimal recovery and restoration of shoulder function.
- Conditions
- Clavicle Fracture
- Being tested
- endobutton under fluoroscopic control (Knotless AC TightRope®)
- Keywords
- endoprosthesis, acromioclavicular dislocations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endobutton under fluoroscopic control (Knotless AC TightRope®)Device
endobutton under fluoroscopic contro
| Study group | Role | What they receive |
|---|---|---|
| un seul bras | Experimental | To evaluate the efficacy of endo-button in the treatment of lateral quarter clavicle fractures and severe acromioclavicular dislocations Receives: Device: endobutton under fluoroscopic control (Knotless AC TightRope®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
maintaining acromioclavicular reduction
The effectiveness of the endo-button (Knotless Acromioclavicular TightRope®) in maintaining acromioclavicular reduction at 6 months will be assessed through radiological imaging.
Measured: at 6 months
Secondary outcomes (6)
Assessment of the number of postoperative complications
Description of all postoperative events
Measured: at 3 weeks, 3months, 6 months and 12 months
Evaluation of the procedure duration
Evaluation of the procedure duration
Measured: at day 1
Evaluation of the healing rate
Evaluation of the healing rate
Measured: at 6 months
Postoperative pain assessment
Postoperative pain assessment aims to measure the intensity, location, and progression of pain experienced by the patient following surgery. It is essential for adjusting analgesic treatments, improving patient comfort, and preventing chronic pain. This evaluation relies on validated tools such as the Visual Analog Scale (VAS) The Visual Analog Scale (VAS) is a simple and widely used tool for measuring the intensity of pain experienced by a patient. It consists of a horizontal line, typically 10 cm long, with one end representing "no pain" (0) and the other end representing "worst imaginable pain" (10). The patient marks a point on the line that corresponds to their perceived pain level, and the distance from the "no pain" end to the mark is measured in centimeters to yield a score from 0 to 10.
Measured: at 3 weeks, 3 months, 6 months ans 12 months
Assessment of shoulder mobility recovery
Assessment of shoulder mobility recovery aims to evaluate functional improvement following surgery or injury. It relies on standardized tools such as the Constant Score, which combines pain, daily activities, range of motion, and muscle strength to provide a comprehensive and objective measure. Additionally, the Subjective Shoulder Value (SSV) offers a simple, patient-reported metric in which the individual rates the function of the affected shoulder as a percentage compared to a normal shoulder, giving a personal perspective on recovery.
Measured: at 3 weeks, 3 months, 6 months and 12 months
Assessment of patients' quality of life
Assessment of patients' quality of life is essential for understanding the broader impact of disease and treatment beyond clinical outcomes. The EQ-5D scale is a standardized instrument used to measure health-related quality of life. It evaluates five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension is rated by the patient, and the results can be converted into a single index value reflecting overall health status. The EQ-5D also includes a visual analog scale (VAS) where patients rate their perceived health from 0 (worst imaginable) to 100 (best imaginable), providing both objective and subjective insights into their well-being.
Measured: at 3 weeks, 3 months , 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start8 Jan 2024
- Primary completionJan 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clavicle FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BOUCHRA BENKESSOU
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, BOUCHRA BENKESSOU, Clinique du Trocadéro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664202
- Sponsor's protocol ID
- 2023-A02204-41
- Acronym
- KAT
- Status last verified
- Jun 2026
- First submitted
- 31 May 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on the Interest of Using an Endobutton Under Fluoroscopic Control Alone to Treat Lateral Quarter Clavicle Fractures and Severe Acromioclavicular Dislocations
- ClinicalTrials.gov ID
- NCT07664202
- Acronym / sponsor ID
- KAT / 2023-A02204-41
- Conditions
- Clavicle Fracture
- Keywords
- endoprosthesis, acromioclavicular dislocations
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- BOUCHRA BENKESSOUUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 24 Jun 2026 (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.
This study aims to inform clinical decision-making by thoroughly examining the outcomes of different treatment approaches for lateral quarter clavicle fractures and acromioclavicular dislocations. By evaluating the safety and efficacy of Knotless AC TightRope® repair devices and comparing short- and long-term results with other fixation techniques, the investigators hope to contribute to the improvement of treatment protocols for these common shoulder injuries. This research could significantly impact patients' quality of life by enabling optimal recovery and restoration of shoulder function.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| un seul bras | Experimental | Device: endobutton under fluoroscopic control (Knotless AC TightRope®)To evaluate the efficacy of endo-button in the treatment of lateral quarter clavicle fractures and severe acromioclavicular dislocations |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting with a fracture of the lateral quarter of the clavicle or a severe acromioclavicular disjunction (Rockwood stages III-V) confirmed by radiological examination
- Patients who have given their consent to participate in the observational study after being informed by the surgeon
Key exclusion criteria (4 listed)
- Minor patients;
- Subjects who are legally protected adults, under guardianship or trusteeship;
- Infection;
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| endobutton under fluoroscopic control (Knotless AC TightRope®)endobutton under fluoroscopic contro | Device | un seul bras |
Primary outcome
maintaining acromioclavicular reduction
Time frame: at 6 months
The effectiveness of the endo-button (Knotless Acromioclavicular TightRope®) in maintaining acromioclavicular reduction at 6 months will be assessed through radiological imaging.
6 secondary outcomes
Assessment of the number of postoperative complications
Time frame: at 3 weeks, 3months, 6 months and 12 months
Evaluation of the procedure duration
Time frame: at day 1
Evaluation of the healing rate
Time frame: at 6 months
Postoperative pain assessment
Time frame: at 3 weeks, 3 months, 6 months ans 12 months
Assessment of shoulder mobility recovery
Time frame: at 3 weeks, 3 months, 6 months and 12 months
Assessment of patients' quality of life
Time frame: at 3 weeks, 3 months , 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Clavicle Fracture, run by BOUCHRA BENKESSOU at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maintaining acromioclavicular reduction (time frame: at 6 months). 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 24 Jun 2026.