Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2020
CompletedFirst Posted
Study publicly available on registry
August 11, 2020
CompletedStudy Start
First participant enrolled
September 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedJanuary 3, 2024
January 1, 2024
3 years
August 4, 2020
January 2, 2024
Conditions
Outcome Measures
Primary Outcomes (7)
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
Study Arms (1)
Operated athletes
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients with other pathologies that interfere with planned physical activity.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Liege
Liège, 4000, Belgium
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
August 4, 2020
First Posted
August 11, 2020
Study Start
September 15, 2021
Primary Completion
September 1, 2024
Study Completion
December 1, 2024
Last Updated
January 3, 2024
Record last verified: 2024-01