NCT04507854

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 15, 2021

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

January 3, 2024

Status Verified

January 1, 2024

Enrollment Period

3 years

First QC Date

August 4, 2020

Last Update Submit

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

EXPERIMENTAL
Other: Strength, range of motion and functional tests + Questionnaire

Interventions

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.

Operated athletes

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

RECRUITING

MeSH Terms

Interventions

Range of Motion, ArticularSurveys and Questionnaires

Intervention Hierarchy (Ancestors)

Physical ExaminationDiagnostic Techniques and ProceduresDiagnosisMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Central Study Contacts

Amandine Gofflot

CONTACT

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

Locations