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Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

Primary Purpose

Chronic Instability of Joint

Status

Completed

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Questionnaires

Isokinetic Strength Measurement

About this trial

This is an interventional screening trial for Chronic Instability of Joint

Eligibility Criteria

18 Years - 30 Years (Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

IDF Medical Corp

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

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.

Outcomes

Primary Outcome Measures

Western Ontario Shoulder Instability index (WOSI)

Functional scale

Secondary Outcome Measures

Fear avoidance belief questionnaire (FABQ)

Fear avoidance questionnaire

Isokinetic strength

Ratios between Internal and External rotation strength in both shoulders

Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

Functional scale

Full Information

NCT ID

NCT02978365

First Posted

November 21, 2016

Last Updated

June 6, 2018

Sponsor

Uri Gottlieb

Collaborators

Wolfson Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02978365

Brief Title

Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

Official Title

Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability - Cross Sectional Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Completed

Study Start Date

March 16, 2017 (Actual)

Primary Completion Date

March 22, 2018 (Actual)

Study Completion Date

March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Uri Gottlieb

Collaborators

Wolfson Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

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

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: The Western Ontario Shoulder Instability index (WOSI) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Instability of Joint

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

44 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Questionnaires

Intervention Description

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

Device

Intervention Name(s)

Isokinetic Strength Measurement

Intervention Description

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

Primary Outcome Measure Information:

Title

Western Ontario Shoulder Instability index (WOSI)

Description

Functional scale

Time Frame

26-28 weeks post surgery

Secondary Outcome Measure Information:

Title

Fear avoidance belief questionnaire (FABQ)

Description

Fear avoidance questionnaire

Time Frame

26-28 weeks post surgery

Title

Isokinetic strength

Description

Ratios between Internal and External rotation strength in both shoulders

Time Frame

26-28 weeks post surgery

Title

Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

Description

Functional scale

Time Frame

26-28 weeks post surgery

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Arnon Gam, M.D

Organizational Affiliation

Medical Corp, Israel Defense Forces

Official's Role

Principal Investigator

Facility Information:

Facility Name

IDF Medical Corp

City

Zrifin

Country

Israel

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Data will be published after statistical analysis only.

Citations:

PubMed Identifier

31370869

Citation

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.

Results Reference

derived

Learn more about this trial

Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

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