Clinical Trials in France / NCT07269418
Active, not recruiting
Observational
Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction
NCT07269418 · tracked via the Priya Life Science France tracker
Condition(s) studied
Acromioclavicular; DislocationLigament Repair or Reconstruction
Study summary
This is a prospective, longitudinal, multicenter, observational cohort study conducted on a population of patients who underwent ligamentoplasty for an acromioclavicular dislocation and who agreed to be followed for a period of two years starting from the day of hospital discharge.
Eligibility
Inclusion Criteria:
* Male or female aged 18 to 60
* Patient who has been informed of the objectives and conditions of the study and who has not objected to participation
* Patient who has undergone reconstruction for an acute Rockwood stage 4 or 5 acromioclavicular dislocation and for whom elbow immobilization was required for 6 weeks (self-rehabilitation in the supine position is possible from day 15, without pendulum or adduction movements).
Exclusion Criteria:
* Time between trauma and ACL reconstruction greater than 10 days
* History of surgery or trauma to the operated shoulder
* History of acromioclavicular surgery or trauma to the contralateral shoulder
* History of shoulder stiffness
* Patient playing a contact sport (rugby, American football)
* Presence of severe acromioclavicular osteoarthritis
* Mental impairment or any other reason that may hinder understanding or strict application of the protocol
* Patient under legal protection, guardianship, or curatorship
* Patient already included in an interventional therapeutic trial
Primary outcome measure(s)
- Acromioclavicular reduction — Month 3
The parameters measured and compared with the contralateral side will be : * The CC (coracoclavicular) distance measured on the anteroposterior Zanca view * The AC-DC distance(Acromial center line to dorsal clavicle) * The GC-PC distance (Glenoid center line to posterior clavicle) Assessment of the result of the intervention on the acromioclavicular radiological reduction 3 months post-operatively according to the quantitative radiographic parameters described by Zumstein. The reduction will be considered as: * Complete if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin of less than 10%. * Partial if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin between 10% and 20%. * Poor if the AC-DC and GC-PC distances on the operated side are equal to those on the healthy side, with a margin greater than 20%.
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Clinique de l'Union | Saint-Jean | France |
More GCS Ramsay Santé pour l'Enseignement et la Recherche trials in France
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07269418 on ClinicalTrials.gov ↗ ← All trials in France