NCT00889109

Brief Summary

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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Last Updated

April 28, 2009

Status Verified

April 1, 2009

Enrollment Period

5 months

First QC Date

April 26, 2009

Last Update Submit

April 27, 2009

Conditions

Outcome Measures

Primary Outcomes (1)

  • Assessment of smoothness parameters of subjects' shoulder movements.

    At least 1 year following surgical repair for anterior shoulder instability

Study Arms (3)

1

Open Capsular Shift

Other: Three dimensional unrestricted arm movements

2

Arthroscopic Bankart Repair

Other: Three dimensional unrestricted arm movements

3

Healthy controls

Other: Three dimensional unrestricted arm movements

Interventions

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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Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients treated in our shoulder outpatients clinic will be candidates for inclusion in this study.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel

Tel Aviv, 69978, Israel

Location

Related Publications (1)

  • Uri O, Pritsch M, Oran A, Liebermann DG. Upper limb kinematics after arthroscopic and open shoulder stabilization. J Shoulder Elbow Surg. 2015 Mar;24(3):399-406. doi: 10.1016/j.jse.2014.08.006. Epub 2014 Oct 22.

Study Officials

  • Dario Liebermann, PhD.

    Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel

    STUDY DIRECTOR
  • Moshe Peri (Pritsch), M.D

    The Shoulder Surgery Unit, Sheba Medical Center, Tel Aviv University, Israel

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

April 26, 2009

First Posted

April 28, 2009

Study Start

July 1, 2009

Primary Completion

December 1, 2009

Last Updated

April 28, 2009

Record last verified: 2009-04

Locations