Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

NCT ID: NCT02978365

Last Updated: 2018-06-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-16

Study Completion Date

2018-03-22

Brief Summary

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Case control study to evaluate different factors (e.g muscle strength, psychological factors) that are associated with full recovery and functional status 6 months after surgical repair of shoulder instability.

Detailed Description

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In this study the investigators will try to find correlations between different factors and functional abilities of patients 6 months post shoulder surgery.

Patients will be examined in a single encounter for muscle strength, fear avoidance beliefs and functional abilities.

Functional abilities will be examined using two validated questionnaires:

1. The Western Ontario Shoulder Instability index (WOSI)
2. Disabilities of the Arm, Shoulder and Hand (DASH)

Fear avoidance will be evaluated using the Fear Avoidance Belief Questionnaire (FABQ)

Muscle strength of the rotator cuff muscles will be measured using Biodex Isokinetic system, model 4.

Conditions

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Chronic Instability of Joint

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Patients

Male patients who undergone shoulder surgery to repair chronic instability (at least 1 shoulder dislocation prior to surgery). Time since surgery will be between 26 and 28 weeks. Patients will go through filling questionnaires and isokinetic strength measurements.

Group Type EXPERIMENTAL

Questionnaires

Intervention Type OTHER

Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).

Isokinetic Strength Measurement

Intervention Type DEVICE

Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)

Interventions

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Questionnaires

Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).

Intervention Type OTHER

Isokinetic Strength Measurement

Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 26-28 weeks s/p surgical repair of shoulder instability
* At least 1 shoulder dislocation prior to surgery

Exclusion Criteria

* Previous surgery in either shoulders
* Any injury in the non-operated shoulder in the last 6 months
* Any history of shoulder dislocation or subluxation in the non-operated shoulder
* Any tendon repair during the surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role collaborator

Uri Gottlieb

OTHER

Sponsor Role lead

Responsible Party

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Uri Gottlieb

Head of Physical Therapy Clinic

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Arnon Gam, M.D

Role: PRINCIPAL_INVESTIGATOR

Medical Corp, Israel Defense Forces

Locations

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IDF Medical Corp

Zrifin, , Israel

Site Status

Countries

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Israel

References

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Gottlieb U, Springer S. Translation and validation of a Hebrew version of the Western Ontario Shoulder Instability index. J Orthop Surg Res. 2019 Aug 1;14(1):245. doi: 10.1186/s13018-019-1289-4.

Reference Type DERIVED
PMID: 31370869 (View on PubMed)

Other Identifiers

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0177-16-WOMC

Identifier Type: OTHER

Identifier Source: secondary_id

IDF-1702-2016

Identifier Type: -

Identifier Source: org_study_id

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