Health TrialsbyHealthPanel

Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations

ConditionClavicle Fracture
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBOUCHRA BENKESSOU

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Minor patients;

Subjects who are legally protected adults, under guardianship or trusteeship;

Infection;

Pregnant or breastfeeding women.

Trial design

Design model

Single group

Treatments tested in this trial

  • endobutton under fluoroscopic control (Knotless AC TightRope®)

    Device

    endobutton under fluoroscopic contro

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: un seul brasExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
at 6 months

Secondary outcomes

1

Assessment of the number of postoperative complications

Description of all postoperative events

Time frame
at 3 weeks, 3months, 6 months and 12 months
2

Evaluation of the procedure duration

Evaluation of the procedure duration

Time frame
at day 1
3

Evaluation of the healing rate

Evaluation of the healing rate

Time frame
at 6 months
4

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.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BOUCHRA BENKESSOU

Lead sponsor

Clinique du Trocadéro

Sponsor institution

Source ClinicalTrials.gov
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