Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

Not Applicable

Completed

• Conditions: Chronic Instability of Joint
• Interventions: Other: Questionnaires; Device: Isokinetic Strength Measurement

• Registration Number: NCT02978365
• Lead Sponsor: Uri Gottlieb

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:

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.

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-28
• Study First Posted: 2016-11-30
• Study Start: 2017-03-16
• Primary Completion: 2018-03-22
• Study Completion: 2018-03-22
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-06
• Last Update Posted: 2018-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 44

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients	Questionnaires	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.
Patients	Isokinetic Strength Measurement	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.

Primary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability index (WOSI)	26-28 weeks post surgery	Functional scale

Secondary Outcome Measures

Name	Time	Method
Fear avoidance belief questionnaire (FABQ)	26-28 weeks post surgery	Fear avoidance questionnaire
Isokinetic strength	26-28 weeks post surgery	Ratios between Internal and External rotation strength in both shoulders
Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)	26-28 weeks post surgery	Functional scale

Trial Locations

Locations (1)

IDF Medical Corp; 🇮🇱 Zrifin, Israel