Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Instability of Joint
• Intervention / Treatment: Other: Questionnaires; Device: Isokinetic Strength Measurement

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 Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel
    • IDF Medical Corp

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Shoulder Instability index (WOSI)	Functional scale	26-28 weeks post surgery

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Uri Gottlieb
• Collaborators: Wolfson Medical Center
• Investigators: Principal Investigator: Arnon Gam, M.D, Medical Corp, Israel Defense Forces

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2017
• Primary Completion (Actual): March 22, 2018
• Study Completion (Actual): March 22, 2018

Study Registration Dates

• First Submitted: November 21, 2016
• First Submitted That Met QC Criteria: November 28, 2016
• First Posted (Estimate): November 30, 2016

Study Record Updates

• Last Update Posted (Actual): June 8, 2018
• Last Update Submitted That Met QC Criteria: June 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Joint Instability
• Other Study ID Numbers: IDF-1702-2016; 0177-16-WOMC (Other Identifier: Wolfson Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data will be published after statistical analysis only.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes