Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

赞助:

合作者:

信息的提供 (责任方):

Clara Isabel de Campos Azevedo，Hospital de Egas Moniz

追踪信息

首次提交日期 ^ICMJE

September 30, 2018

首次发布日期e ^ICMJE

October 3, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

October 1, 2018

预计主要完成日期

July 31, 2020 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Shoulder range of motion (ROM)[ Time Frame: 2 years ]

Bilateral shoulder active range of motion (ROM): elevation (0 -180º), abduction (0 -180º) and external rotation (0 -100º), measured in degrees ; and internal rotation, defined as the highest vertebral body that the patient's thumb can reach, converted afterwards to a scale of 1-5 points: lateral thigh=0; buttock=1; sacrum=2; lumbar=3; 12th thoracic vertebra=4; 7th thoracic vertebra=5; for every scale range provided, higher values represent a better outcome.

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Shoulder Strength[ Time Frame: 2 years ]
minimum 0 - maximum 25 kilograms, measured using a digital dynamometer; for every scale range provided, higher values represent a better outcome.
The ROWE score[ Time Frame: 2 years ]
0 -100 points: Section 1 - Stability No Recurrence, subluxation or apprehension (50 points) Apprehension when placing arm in certain positions (30 points) Subluxation (not requiring reduction) (10 points) Recurrent Dislocation (0 points) Section 2 - Motion 100% of normal ext rotation, int rotation and elevation (20 points) 75% of normal ext rotation, int rotation and elevation (15 points) 50% of normal ext rotation, int rotation and elevation (5 points) 50% of normal elevation, and int rotation, No ext rotation (0 points) Section 3 - Function No limitation of work or sports, little or no discomfort (eg shoulder strong overhead, lifting, swimming, throwing, tennis) (30 points) Mild limitation and minimum discomfort (25 points) Moderate limitation and discomfort (10 points) Marked limitation and pain (0 points) For every scale range provided, higher values represent a better outcome.
The Western Ontario Shoulder Instability Index (WOSI)[ Time Frame: 2 years ]
0-2100 (0-100%), the WOSI score instrument (Kirkley et al. 1998) consists of 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100; for every scale range provided, higher values represent a worse outcome.

描述性信息

简略标题 ^ICMJE

Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps

正式标题 ^ICMJE

Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results

简要概况

Clinical study of patients with a history of traumatic anterior shoulder dislocations to test the hypothesis that the arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis produces progressive good clinical and imagiological results.

详细说明

Patients with a history of traumatic anterior shoulder dislocations with documented imagological Bankart and HillSachs lesions who meet the eligibility criteria will be enrolled in the study and undergo an arthroscopic dynamic anterior capsular stabilization technique with trans subscapular long head of the biceps tenodesis. All patients will be clinically and radiologically/imagiologically assessed preoperatively and at the 6-months, 12-months and 2-years postoperative evaluations. The range of motion (ROM), shoulder abduction strength, Constant, ROWE and WOSI scores will be compared from preoperative to 6 months postoperative; from 6 months postoperative to 12 months postoperative; and from 12 months to 2 years postoperative (paired-samples t-test, two-tailed). All continuous variables will be compared between the group of patients with failures (a failure is defined as a patient who suffers an objective re-dislocation episode during the 2-year follow-up) and the group without failures (Mann-Whitney U test). All categorical variables and outcome results will be compared between the two groups (Fisher's exact test). A significant difference will be defined as P<0.05.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配:
干预模型: Single Group Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Treatment

适用条件 ^ICMJE

干预项目 ^ICMJE

Procedure: Dynamic Anterior Stabilization
All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors

研究工具

Experimental: Dynamic Anterior Stabilization
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

September 30, 2020

预计主要完成日期

July 31, 2020 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Bankart lesion and Hill Sachs lesions on the magnetic resonance imaging - one or more traumatic anterior shoulder dislocation episodes - contact or forced overhead sport or work activity Exclusion Criteria: - proximal humerus fracture - rotator cuff tear requiring repair

性别

参与研究的性别:

All

年龄

最小年龄：N/A ，最大年龄：N/A

接受健康的志愿者

没有

可入组国家 ^ICMJE

Portugal

管理信息

数据检测委员会

Yes

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

责任方

Clara Isabel de Campos Azevedo，Hospital de Egas Moniz

研究赞助商 ^ICMJE

Hospital de Egas Moniz

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Clara Azevedo, MD Centro Hospitalar de Lisboa Ocidental

PRS 账户

Hospital de Egas Moniz

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

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