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

Sponsor
University of Liege (Other)
Overall Status
Recruiting
CT.gov ID
NCT04507854
Collaborator
(none)
80
1
1
38.5
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Strength, range of motion and functional tests + Questionnaire
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.
Actual Study Start Date :
Sep 15, 2021
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Strength test [6 months from the surgery]

    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.

  2. Range of motion [6 months from the surgery]

    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.

  3. Functional test [6 months from the surgery]

    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.

  4. Questionnaire DASH [6 months from the surgery]

    The questionnaire that athletes will complete will be the DASH (Disabilities of the Arm, Shoulder and Hand Scale) questionnaire.

  5. Follow-up questionnaire at 12 months [At 12 months from the surgery]

    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.

  6. Follow-up questionnaire at 18 months [At 18 months from the surgery]

    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.

  7. Follow-up questionnaire at 24 months [At 24 months from the surgery]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 35 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Liege Liège Belgium 4000

Sponsors and Collaborators

  • University of Liege

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gofflot Amandine, Principal Investigator, University of Liege
ClinicalTrials.gov Identifier:
NCT04507854
Other Study ID Numbers:
  • 04082020
First Posted:
Aug 11, 2020
Last Update Posted:
Jun 10, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jun 10, 2022