160 / 5 000 Evaluation of the Result of Conoid Ligament Reconstruction According to an Anatomical Index in the Arthroscopic Treatment of Acromioclavicular Disjunctions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Acromioclavicular reduction
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
结局指标
主要结局
Acromioclavicular reduction
时间窗: 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%.
次要结局
- 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)
- Shoulder Functional assessment with the SSV Score (Subjective Shoulder Value Score)(Month 24)
- Resumption of physical and sporting activities with the ACJI score(Month 3)