Clinique de l'Union
Saint-Jean, 31240, France
NCT Number: NCT07269418
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.
This study is active but is not currently recruiting participants.
Notify Me18 year–60 year
All sexes
Observational
Saint-Jean, 31240, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Month 3
The parameters measured and compared with the contralateral side will be :
The reduction will be considered as:
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) :
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:
Time frame: Month 24
Time to return to work after discharge from hospital
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):
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).
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).
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:
GCS Ramsay Santé pour l'Enseignement et la Recherche
Other
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
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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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