Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction (ORACLE)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Active, not recruiting

Conditions: Acromioclavicular; Dislocation; Ligament Repair or Reconstruction

Study type: Observational

Funder types: Other

Identifiers

NCT07269418

COS-RGDS-2019-06-035-P-GUINAND

ID-RCB 2023-A02062-43 (Other Identifier)

Details and patient eligibility

About

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.

Full description

The objective of this study is purely observational. This study modifies the normal doctor-patient relationship due to the need for additional evaluations aimed at assessing the long-term functional outcome of the intervention through the administration of questionnaires.

The study will be carried out in five centers : the Clinique de l'Union in Toulouse (Saint-Jean), the Niçois Institute of Sport and Arthrosis in Nice, the Confluent Private Hospital in Nantes, the Clinique du Cap d'Or in La Seyne-sur-Mer and the Savoie Metropole Hospital Center in Chambéry.

Enrollment: 36 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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