Dynamic Anterior Stabilization With Transsubscapular Long Head of the Biceps
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03693716|
Recruitment Status : Recruiting
First Posted : October 3, 2018
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Anterior Shoulder Dislocation Bankart Lesion Hill Sachs Lesion||Procedure: Dynamic Anterior Stabilization||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Arthroscopic Dynamic Anterior Capsular Stabilization With Trans Subscapular Long Head of the Biceps Tenodesis in Anterior Shoulder Instability - Clinical and Imagiological Results|
|Actual Study Start Date :||September 20, 2018|
|Estimated Primary Completion Date :||July 31, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Dynamic Anterior Stabilization
Arthroscopic Dynamic Anterior Capsular Stabilization with Trans subscapular Long Head of the Biceps Tenodesis
Procedure: Dynamic Anterior Stabilization
All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03693716
|Contact: Clara Azevedo, MDemail@example.com|
|Centro Hospitalar de Lisboa Ocidental||Recruiting|
|Lisboa, Portugal, 1700-348|
|Contact: Clara Azevedo, MD 00351938453848 firstname.lastname@example.org|
|Contact: Clara Azevedo 00351938453848 email@example.com|
|Principal Investigator:||Clara Azevedo, MD||Centro Hospitalar de Lisboa Ocidental|