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NCT Number: NCT02978365

Factors Associated With Full Recovery After Surgical Repair of Shoulder Instability

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.

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Key information

Conditions

Chronic Instability of Joint

Age range

18 year–30 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IDF Medical Corp

Zrifin, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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).

Isokinetic Strength Measurement

Device

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

Primary outcomes

  1. Western Ontario Shoulder Instability index (WOSI)

    Time frame: 26-28 weeks post surgery

    Functional scale

Secondary outcomes

  1. Fear avoidance belief questionnaire (FABQ)

    Time frame: 26-28 weeks post surgery

    Fear avoidance questionnaire

  2. Isokinetic strength

    Time frame: 26-28 weeks post surgery

    Ratios between Internal and External rotation strength in both shoulders

  3. Disabilities of Arm, Shoulder and Hand Questionnaire (DASH)

    Time frame: 26-28 weeks post surgery

    Functional scale

Sponsors and collaborators

Lead sponsor

Uri Gottlieb

Other

Collaborators

  • Wolfson Medical Center

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 30, 2016
Registry last updated
Jun 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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