Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

Chronic Instability of Joint Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02978365
• Other study ID #: IDF-1702-2016
• Secondary ID: 0177-16-WOMC
• Status: Completed
• Phase: N/A
• Start date: March 16, 2017
• Est. completion date: March 22, 2018

Study information

• Verified date: June 2018
• Source: Medical Corps, Israel Defense Force
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: March 22, 2018
• Est. primary completion date: March 22, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Instability of Joint
• Joint Instability

Intervention

Other:
• 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).

Device:
• Isokinetic Strength Measurement
Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)

Locations

Country	Name	City	State
Israel	IDF Medical Corp	Zrifin

Sponsors (2)

Lead Sponsor	Collaborator
Uri Gottlieb	Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario Shoulder Instability index (WOSI)	Functional scale	26-28 weeks post surgery
Secondary	Fear avoidance belief questionnaire (FABQ)	Fear avoidance questionnaire	26-28 weeks post surgery
Secondary	Isokinetic strength	Ratios between Internal and External rotation strength in both shoulders	26-28 weeks post surgery
Secondary	Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)	Functional scale	26-28 weeks post surgery