Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.

The purpose of this study is to determine whether certain criteria for returning to the field can be predictive of a return of the athlete to a level of performance similar to that of before his shoulder injury. In this context, these different criteria will be tested at 6 months in post-surgery while performance monitoring will be carried out at 12, 18 and 24 months.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Shoulder; Return to Sport
• Intervention / Treatment: Other: Strength, range of motion and functional tests + Questionnaire

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amandine Gofflot; Phone Number: +3243662193; Email: agofflot@uliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • University of Liege
    • Contact: Amandine Gofflot; Phone Number: +3243662193; Email: gofflot.amandine@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Athletes playing sports soliciting the upper limb (> 3 hours per week)
• Athletes between 18 and 35 years of age
• Patients with recent Bankart or Latarjet shoulder surgery (less than 4 months ago)
• Patients accepting the study protocol

Exclusion Criteria:

• Patients with other pathologies that interfere with planned physical activity.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• 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: Operated athletes	Other: Strength, range of motion and functional tests + Questionnaire; Patients undergoing instability surgery will perform amplitude, strength, functional tests and a questionnaire at 6 months of the operation. Then they will be contacted at 12, 18 and 24 months to find out if they have regained their performance level or if they have injured their shoulder again.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Strength test	The strength will be assess with a isokinetic device. It will allow to calculate the maximum force of the subject at the level of the rotators of the shoulder. This is a dorsal decubitus test. The subject's arm will be positioned in 90° of abduction of shoulder abduction. In this position, the subject will perform tests at different speeds (60°/s concentric, 240°/s concentric and 60°/s eccentric). This will calculate the maximum force.	6 months from the surgery
Range of motion	This test will consist of a measurement of the active and passive joint amplitudes of the athlete. Different movements will be tested: flexion, extension, abduction, external rotation elbow to body, hand-back, internal/external rotations at 90° arm abduction in frontal plane.	6 months from the surgery
Functional test	Two functional tests will be proposed, one closed chain and the other open chain. Athletes will realize the one that comes closest to their daily practice. The Upper Quarter Y-Balance test will be performed by athletes in closed-chain sports. The second proposed test will be the medicine ball throw.	6 months from the surgery
Questionnaire DASH	The questionnaire that athletes will complete will be the DASH (Disabilities of the Arm, Shoulder and Hand Scale) questionnaire.	6 months from the surgery
Follow-up questionnaire at 12 months	Athletes will be asked to answer different questions about their performance level since their sports restart at 12, 18 and 24 months post-operation. We will also look into a possible recurrence of injury to their shoulder.	At 12 months from the surgery
Follow-up questionnaire at 18 months	Athletes will be asked to answer different questions about their performance level since their sports restart at 12, 18 and 24 months post-operation. We will also look into a possible recurrence of injury to their shoulder.	At 18 months from the surgery
Follow-up questionnaire at 24 months	Athletes will be asked to answer different questions about their performance level since their sports restart at 12, 18 and 24 months post-operation. We will also look into a possible recurrence of injury to their shoulder.	At 24 months from the surgery

Collaborators and Investigators

• Sponsor: University of Liege

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: August 4, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (Actual): August 11, 2020

Study Record Updates

• Last Update Posted (Estimated): January 3, 2024
• Last Update Submitted That Met QC Criteria: January 2, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 04082020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No