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临床试验/CTRI/2025/10/096519
CTRI/2025/10/096519尚未招募3 期

Assessment of Functional outcomes and re dislocation rate after single anchor versus double anchor configuration in Arthroscopic Remplissage and Bankart Repair

Post Graduate Institute of Medical Education & Research, Chandigarh1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年11月11日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
1- ASES-American shoulder and Elbow surgeons score

研究概览

简要总结

Patient presents to Orthopaedic OPD,PGIMER. The patients will be assessed for duration of instability, details of first dislocation including trauma, time to reduction, period of immobilisation, rehabilitation, time to second dislocation, Total no. of dislocations, present difficulty in activities of daily living. Clinical tests will be perfomed- Apprehension test, Sulcus test and Anterior Drawer test. Inclusion and exclusion criterias will be checked. Radiological Study will also be done- XRAY,CT and MRI -Humeral head defect and Glenoid defect will be calculated.Once patient gets admitted for the surgery, his/her data will be entered to our database and the group will be allotted for him based on the number he is at, in our study from the block randomisation generated using computer generated randomisation. Randomisation will bedone for using single anchor vs double anchor configuration in Arthroscopic Remplissage and Bankart Repair.There will be a Rehabilitation Programme.

Primary outcome variable will be compared - ASES, Rowe Score and Constant Murley score at 3 months and 6 months and secondary outcome variables. so we will do assessment of Functional outcomes and re-dislocation rate after single anchor vs double anchor configuration in Arthroscopic Remplissage and Bankart Repair.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • All skeletally mature adults of either sex ,aged 18 to 75 years with recurrent anterior shoulder instability.

排除标准

  • Arthritis of Shoulder joint (Osteoarthritis, Rheumatoid arthritis, septic arthritis) 2)Bilateral recurrent shoulder dislocation 3)Shoulder instability because of an irreparable cuff tear 4)Habitual shoulder dislocation 5)Any patient who withholds consent.

结局指标

主要结局

1- ASES-American shoulder and Elbow surgeons score

时间窗: 3 months and 6 months

2-Rowe Score

时间窗: 3 months and 6 months

3-Constant Murley Score

时间窗: 3 months and 6 months

次要结局

  • To compare external rotation(6 weeks, 3months and 6 months)

研究者

发起方
Post Graduate Institute of Medical Education & Research, Chandigarh
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Aman Yadav

Postgraduate Institute of Medical Education and Research

研究点 (1)

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