Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations

NCT07664202 | Recruiting DMC

• 1 other identifier: 2023-A02204-41
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

endoprosthesis; acromioclavicular dislocations

Outcome Measures

Primary Outcomes (1)

• 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.

  at 6 months

Secondary Outcomes (6)

• Assessment of the number of postoperative complications

  at 3 weeks, 3months, 6 months and 12 months

• Evaluation of the procedure duration

  at day 1

• Evaluation of the healing rate

  at 6 months

• Postoperative pain assessment

  at 3 weeks, 3 months, 6 months ans 12 months

• Assessment of shoulder mobility recovery

  at 3 weeks, 3 months, 6 months and 12 months

Study Arms (1)

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EXPERIMENTAL

To evaluate the efficacy of endo-button in the treatment of lateral quarter clavicle fractures and severe acromioclavicular dislocations

Device: endobutton under fluoroscopic control (Knotless AC TightRope®)

Interventions

endobutton under fluoroscopic control (Knotless AC TightRope®) DEVICE

endobutton under fluoroscopic contro

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Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Minor patients;
• Subjects who are legally protected adults, under guardianship or trusteeship;
• Infection;
• Pregnant or breastfeeding women.

Sponsors & Collaborators

• BOUCHRA BENKESSOU: lead

Study Sites (1)

Clinique Du Trocadéro

Paris, 75116, France

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: May 31, 2024
• First Posted: June 24, 2026
• Study Start: January 8, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

FR (1)