Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

NCT02978365 | Completed FDA Device

• 2 other identifiers: IDF-1702-20160177-16-WOMC
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Instability of Joint

Outcome Measures

Primary Outcomes (1)

• Western Ontario Shoulder Instability index (WOSI)

  Functional scale

  26-28 weeks post surgery

Secondary Outcomes (3)

• Fear avoidance belief questionnaire (FABQ)

  26-28 weeks post surgery

• Isokinetic strength

  26-28 weeks post surgery

• Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

  26-28 weeks post surgery

Study Arms (1)

Patients

EXPERIMENTAL

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; Device: Isokinetic Strength Measurement

Interventions

Questionnaires 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).

Patients

Isokinetic Strength Measurement DEVICE

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

Patients

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• weeks s/p surgical repair of shoulder instability
• At least 1 shoulder dislocation prior to surgery

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uri Gottlieb: lead
• Wolfson Medical Center: collaborator

Study Sites (1)

IDF Medical Corp

Zrifin, Israel

Location

Related Publications (1)

• 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.

  PMID: 31370869 DERIVED

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Arnon Gam, M.D

  Medical Corp, Israel Defense Forces

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of Physical Therapy Clinic

Study Record Dates

• First Submitted: November 21, 2016
• First Posted: November 30, 2016
• Study Start: March 16, 2017
• Primary Completion: March 22, 2018
• Study Completion: March 22, 2018
• Last Updated: June 8, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)