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临床试验/NCT03739749
NCT03739749撤回不适用

Arthroscopic Superior Capsular Reconstruction - Multicentric Prospective Comparative Study of Different Types of Grafts

Hospital de Egas Moniz2 个研究点 分布在 1 个国家开始时间: 2018年10月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Constant score

研究概览

简要总结

Multicentric prospective clinical and radiological comparative study of consecutive patients with irreparable rotator cuff tears to test the hypothesis that there are significant differences in the improvement of the clinical and imaging outcomes of arthroscopic superior capsular reconstruction (ASCR) when a different type of graft is used.

详细描述

Patients with irreparable rotator cuff tears who meet the eligibility criteria will be enrolled in the study and undergo arthroscopic superior capsular reconstruction using one of the following types of graft: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft.

All patients will be assessed clinically, radiologically and with an MRI preoperatively and at the 6-months and at the 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant (CS), simple shoulder test (SST) and subjective shoulder value (SSV) scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 2 years postoperative (paired-samples t-test, two-tailed) in each group (allotment to groups is performed according to the type of graft used: fascia lata autograft, fascia lata allograft, Achilles tendon allograft, bovine pericardium xenograft, swine dermal xenograft, or collagen graft). The differences in ROM, shoulder abduction strength, CS, SST and SSV scores from preoperative to 6 months postoperative and from 6 months postoperative to 2 years postoperative will be compared between groups. All continuous variables will be compared between the group of patients with graft tears and the group without graft tears (Mann-Whitney U test). All categorical variables and outcome results will be compared between groups (Fisher's exact test). A significant difference will be defined as P<0.05.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Rotator cuff tear arthropathy, Hamada stage 1 or 2
  • Complete rotator cuff tendon tear involving one or more tendons, with a Patte stage 3 tendon retraction on the preoperative magnetic resonance imaging

排除标准

  • Rotator cuff tear arthropathy, Hamada stage 3 or 4
  • Complete rotator cuff tendon tear involving one or more tendons, with Patte stage 1 or 2 tendon retraction on the preoperative magnetic resonance imaging
  • Proximal humerus fracture
  • Acute shoulder dislocation (in the previous 8 weeks)

结局指标

主要结局

Constant score

时间窗: 2 years

Constant score at 2 years postoperatively (minimum 1 point - maximum 100 points); For the scale range provided, higher values represent a better outcome

次要结局

  • Simple shoulder test(2 years)
  • Shoulder strength(2 years)
  • Graft integrity on the magnetic resonance imaging(2 years)
  • Shoulder active range of motion(2 years)
  • Acromiohumeral interval(2 years)

研究者

发起方
Hospital de Egas Moniz
申办方类型
Other
责任方
Principal Investigator
主要研究者

Clara Isabel de Campos Azevedo

Principal Investigator

Hospital de Egas Moniz

研究点 (2)

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