Acromioclavicular; DislocationORACLENCT07269418
Optimization of Conoid Anatomical Reconstruction During Ligamentoplasty for Acromioclavicular Disjunction
An observational study of Acromioclavicular; Dislocation and Ligament Repair or Reconstruction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acromioclavicular; Dislocation, Ligament Repair or Reconstruction
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2024to Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patient operated on for anatomic ligament reconstruction for an acromioclavicular disjunction
Who may be able to join
- 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).
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 160 / 5 000 Evaluation of the Result of Conoid Ligament Reconstruction According to an Anatomical Index in the Arthroscopic Treatment of Acromioclavicular Disjunctions
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.
Read the detailed 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.
- Keywords
- anatomic ligament reconstruction, acromioclavicular disjunction
- Medical subject headings
- Joint Dislocations
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: Month 3
Secondary outcomes (7)
Pain assessement
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
Measured: Month 24
Shoulder functional assessment with the the ACJI Score (Acromioclavicular Joint Instability Score)
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.
Measured: Month 3
Return to work
Time to return to work after discharge from hospital
Measured: Month 24
Resumption of physical and sporting activities (with the Self-Constant score)
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)
Measured: Month 24
Patient satisfaction
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).
Measured: Month 24
Shoulder Functional assessment with the SSV Score (Subjective Shoulder Value Score)
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).
Measured: Month 24
Resumption of physical and sporting activities with the ACJI score
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.
Measured: Month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start28 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acromioclavicular; DislocationStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269418
- Sponsor's protocol ID
- COS-RGDS-2019-06-035-P-GUINAND
- Other IDs
- ID-RCB 2023-A02062-43
- Acronym
- ORACLE
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 160 / 5 000 Evaluation of the Result of Conoid Ligament Reconstruction According to an Anatomical Index in the Arthroscopic Treatment of Acromioclavicular Disjunctions
- ClinicalTrials.gov ID
- NCT07269418
- Acronym / sponsor ID
- ORACLE / COS-RGDS-2019-06-035-P-GUINAND
- Keywords
- anatomic ligament reconstruction, acromioclavicular disjunction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2028 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patient operated on for anatomic ligament reconstruction for an acromioclavicular disjunction
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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%.
7 secondary outcomes
Pain assessement
Time frame: Month 24
Shoulder functional assessment with the the ACJI Score (Acromioclavicular Joint Instability Score)
Time frame: Month 3
Return to work
Time frame: Month 24
Resumption of physical and sporting activities (with the Self-Constant score)
Time frame: Month 24
Patient satisfaction
Time frame: Month 24
Shoulder Functional assessment with the SSV Score (Subjective Shoulder Value Score)
Time frame: Month 24
Resumption of physical and sporting activities with the ACJI score
Time frame: Month 3
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acromioclavicular; Dislocation and Ligament Repair or Reconstruction, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acromioclavicular reduction (time frame: Month 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.