Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction

NCT ID: NCT07269418

Last Updated: 2025-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-28

Study Completion Date

2028-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acromioclavicular; Dislocation Ligament Repair or Reconstruction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Clinique de l'Union

Saint-Jean, , France

Site Status

Countries

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France

Other Identifiers

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ID-RCB 2023-A02062-43

Identifier Type: OTHER

Identifier Source: secondary_id

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

Identifier Type: -

Identifier Source: org_study_id

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