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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04507854
• Other study ID #: 04082020
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Liege
• Contact: Amandine Gofflot
• Phone: +3243662193
• Email: agofflot[@]uliege.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Return to Sport
• Shoulder
• Surgery

Intervention

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.

Locations

Country	Name	City	State
Belgium	University of Liege	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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