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Shoulder Proprioception Following Open and Arthroscopic Instability Repair

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00889109
First received: April 26, 2009
Last updated: April 27, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention
Shoulder Proprioception
Open Capsular Shift
Arthroscopic Bankart Repair
Unrestricted Arm Movement
Other: Three dimensional unrestricted arm movements

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Proprioception of the Glenohumeral Joint Following Open and Arthroscopic Repair for Anterior Shoulder Instability

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Assessment of smoothness parameters of subjects' shoulder movements. [ Time Frame: At least 1 year following surgical repair for anterior shoulder instability ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: July 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1
Open Capsular Shift
Other: Three dimensional unrestricted arm movements
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.
2
Arthroscopic Bankart Repair
Other: Three dimensional unrestricted arm movements
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
Other: Three dimensional unrestricted arm movements
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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00889109

Contacts
Contact: Ofir Uri, M.D 972-52-4262285 ofiruri@gmail.com

Locations
Israel
Department of Physical Therapy, Sackler Faculty of Medicine, Tel Aviv University, Israel Not yet recruiting
Tel Aviv, Israel, 69978
Contact: Dario Liebermann, PhD.       dlieberm@post.tau.ac.il   
Sponsors and Collaborators
Sheba Medical Center
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
  More Information

No publications provided

Responsible Party: Dr. Ariel Oran M.D, The Shoulder Surgery Unit, Sheba Medical Center, Tel Hashomer, Israel
ClinicalTrials.gov Identifier: NCT00889109     History of Changes
Other Study ID Numbers: SHEBA-09-7068-AO-CTIL
Study First Received: April 26, 2009
Last Updated: April 27, 2009
Health Authority: Israel: Ministry of Health

ClinicalTrials.gov processed this record on November 20, 2014