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NCT Number: NCT07269418

Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique de l'Union

Saint-Jean, 31240, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Acromioclavicular reduction

    Time frame: 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%.

Secondary outcomes

  1. Pain assessement

    Time frame: Month 24

    Progression of pain with the Self-Constant score.

    Self-Constant score explores several domains such as pain, activity, strength, and mobility(functional evaluation) :

    • Pain is assessed using a numerical scale ranging from 0 (no pain) to 10 (unbearable pain)
    • Professional and leisure activities are evaluated by the patient using a numerical scale ranging from 0 (no activities possible) to 10 (all activities possible)
    • Mobility: the ranges to be considered are those that are possible actively and without pain. Active anterior elevation, active abduction, and active external rotation are evaluated by the patient with reference to photographs showing the different levels of range of motion
    • Muscle strength is evaluated according to the patient's ability to lift a certain number of common objects (from a 500 g can to a 9 kg pack of water) The total score ranges from 0 to 100 points, with 100 indicating a normal shoulder and 0 indicating a completely deficient shoulder
  2. Shoulder functional assessment with the the ACJI Score (Acromioclavicular Joint Instability Score)

    Time frame: Month 3

    Describe, over the 2 years following surgery, changes in shoulder function scores:

    The ACJI Score (Acromioclavicular Joint Instability Score) assesses acromioclavicular joint instability across five dimensions:

    • Spontaneous pain and pain on palpation (out of 20 points)
    • Activities of daily living (out of 10 points)
    • Aesthetics (out of 10 points)
    • Function (out of 25 points), including evaluation of range of motion (flexion, abduction, external rotation, internal rotation) and abduction strength at 90° abduction
    • Radiological findings (out of 35 points): post-traumatic osteoarthritis, vertical stability, and horizontal stability The final score ranges from 0 to 100, with 0 corresponding to almost no function and 100 to normal function.
  3. Return to work

    Time frame: Month 24

    Time to return to work after discharge from hospital

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

    Time frame: Month 24

    Describe, over the 2 years following the intervention, the time and level of resumption of physical and sporting activities with Self-Constant score ranges from 0 (deficient shoulder) to 100 (normal shouder).

    Self-Constant score explores several domains such as pain, activity, strength, and mobility (functional evaluation):

    • Pain is assessed using a numerical scale ranging from 0 (no pain) to 10 (unbearable pain)
    • Professional and leisure activities are evaluated by the patient using a numerical scale ranging from 0 (no activities possible) to 10 (all activities possible)
    • Mobility: the ranges to be considered are those that are possible actively and without pain. Active anterior elevation, active abduction, and active external rotation are evaluated by the patient with reference to photographs showing the different levels of range of motion
    • Muscle strength is evaluated according to the patient's ability to lift a certain number of common objects (from 500g can to 9kg pack of water)
  5. Patient satisfaction

    Time frame: Month 24

    Overall Assessment of Patient Satisfaction : Patient satisfaction with their care and outcomes will be assessed at the end of the study on a simple numerical scale ranging from 0 (very dissatisfied) to 10 (very satisfied).

  6. Shoulder Functional assessment with the SSV Score (Subjective Shoulder Value Score)

    Time frame: Month 24

    Describe, over the 2 years following surgery, changes in shoulder function scores : The SSV Score (Subjective Shoulder Value Score) is a subjective assessment score that allows the patient to evaluate the value of their affected shoulder compared to a completely healthy shoulder. The result is expressed as a percentage (between 0 % and 100%, 0 is an anormal function and 100% a normal function of the shoulder).

  7. Resumption of physical and sporting activities with the ACJI score

    Time frame: Month 3

    Describe, over the 2 years following the intervention, the time and level of resumption of physical and sporting activities with the ACJI score (acromioclavicular joint instability score).

    The ACJI Score (Acromioclavicular Joint Instability Score) assesses acromioclavicular joint instability across five dimensions:

    • Spontaneous pain and pain on palpation (out of 20 points)
    • Activities of daily living (out of 10 points)
    • Aesthetics (out of 10 points)
    • Function (out of 25 points), including evaluation of range of motion (flexion, abduction, external rotation, internal rotation) and abduction strength at 90° abduction
    • Radiological findings (out of 35 points): post-traumatic osteoarthritis, vertical stability, and horizontal stability The final score ranges from 0 to 100, with 0 corresponding to almost no function and 100 to normal function.

Sponsors and collaborators

Lead sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Other

Registry information

Official study title

160 / 5 000 Evaluation of the Result of Conoid Ligament Reconstruction According to an Anatomical Index in the Arthroscopic Treatment of Acromioclavicular Disjunctions

Acronym: ORACLE

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Dec 8, 2025
Registry last updated
Dec 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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