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Recruiting NCT07664202

Fluoroscopic Endobutton in Clavicle Fractures and AC Dislocations

No phase Interventional Clavicle Fracture

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: endobutton under fluoroscopic control (Knotless AC TightRope®).
Who it may be relevant to
Registry conditions: Clavicle Fracture. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Device endobutton under fluoroscopic control (Knotless AC TightRope®)
    endobutton under fluoroscopic contro

Primary outcome measures

  • maintaining acromioclavicular reduction [Time frame: at 6 months]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • Clinique Du Trocadéro — Paris

Identifiers

NCT: NCT07664202 · 2023-A02204-41

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗