Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction

NCT07269418 | Active Not Recruiting

• 2 other identifiers: COS-RGDS-2019-06-035-P-GUINANDID-RCB 2023-A02062-43
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acromioclavicular; Dislocation; Ligament Repair or Reconstruction

Keywords

anatomic ligament reconstruction; acromioclavicular disjunction

Outcome Measures

Primary Outcomes (1)

• Acromioclavicular reduction

  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%.

  Month 3

Secondary Outcomes (7)

• Pain assessement

  Month 24

• Shoulder functional assessment with the the ACJI Score (Acromioclavicular Joint Instability Score)

  Month 3

• Return to work

  Month 24

• Resumption of physical and sporting activities (with the Self-Constant score)

  Month 24

• Patient satisfaction

  Month 24

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patient operated on for anatomic ligament reconstruction for an acromioclavicular disjunction

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clinique de l'Union

Saint-Jean, 31240, France

Location

MeSH Terms

Conditions

Joint Dislocations

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2025
• First Posted: December 8, 2025
• Study Start: March 28, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: December 8, 2025

Record last verified: 2025-11

Locations

FR (1)