- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00889109
Shoulder Proprioception Following Open and Arthroscopic Instability Repair
Proprioception of the Glenohumeral Joint Following Open and Arthroscopic Repair for Anterior Shoulder Instability
Shoulder dislocations are common and may result in functionally disabling instability. Disruption of the shoulder capsuloligamentous complex during shoulder dislocation is related to poor proprioceptive and stabilizing capabilities of the joint. It has been demonstrated that surgical restoration of the normal glenohumeral capsular tensioning improves the proprioceptive capability of the shoulder and plays an important roll in restoring shoulder stability.
Several studies compared the proprioceptive capabilities of the shoulder between different surgical procedures, however only few have used the "dynamic unrestricted 3-dimensional arm movement model" that has been shown to be more appropriate for assessment of glenohumeral proprioception. To our knowledge, no previous study has compared proprioception measures of the glenohumeral joint following arthroscopic versus open repair for anterior shoulder instability, using the 3-dimensional unrestricted arm movement model.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Tel Aviv, Israel, 69978
- Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who are at least one year after a single operation for anterior shoulder instability of their dominant arm
- control subjects will be healthy volunteers with no history of shoulder complaints selected to match the age and gender of subjects
Exclusion Criteria:
- Neurological impairment involving the upper extremities
- Instability or recurrent dislocation of the operated shoulder
- Another surgery of the dominant extremity besides the single stabilization procedure
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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1
Open Capsular Shift
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The subjects will carry out three dimensional unrestricted arm movements.
The subjects' movements will be recorded by optoelectronic infrared cameras and software.
Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception.
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2
Arthroscopic Bankart Repair
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The subjects will carry out three dimensional unrestricted arm movements.
The subjects' movements will be recorded by optoelectronic infrared cameras and software.
Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception.
|
|
3
Healthy controls
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The subjects will carry out three dimensional unrestricted arm movements.
The subjects' movements will be recorded by optoelectronic infrared cameras and software.
Assessment of smoothness parameters of subjects' movements will allow discriminating between subjects with intact or impaired proprioception.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Assessment of smoothness parameters of subjects' shoulder movements.
Time Frame: At least 1 year following surgical repair for anterior shoulder instability
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At least 1 year following surgical repair for anterior shoulder instability
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Dario Liebermann, PhD., Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel
- Study Chair: Moshe Peri (Pritsch), M.D, The Shoulder Surgery Unit, Sheba Medical Center, Tel Aviv University, Israel
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- SHEBA-09-7068-AO-CTIL
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