ShoulderNCT04507854
Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.
A study testing Strength, range of motion and functional tests + Questionnaire in people with Shoulder and Return to Sport, run by University of Liege at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Shoulder, Return to Sport, Surgery
- What is being tested?
- Strength, range of motion and functional tests + Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Sep 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with other pathologies that interfere with planned physical activity.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University of Liege
Liège, 4000
Amandine Gofflot, +3243662193, gofflot.amandine@gmail.com
About this study
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.
- Conditions
- Shoulder, Return to Sport, Surgery
- Being tested
- Strength, range of motion and functional tests + Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strength, range of motion and functional tests + QuestionnaireOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Operated athletes | Experimental | Not described Receives: Other: Strength, range of motion and functional tests + Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At 24 months from the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start15 Sep 2021
- Primary completionSep 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShoulderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gofflot Amandine, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04507854
- Sponsor's protocol ID
- 04082020
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2020
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Return to Performance Criteria Following Shoulder Instability Surgery in the Athlete.
- ClinicalTrials.gov ID
- NCT04507854
- Acronym / sponsor ID
- 04082020
- Conditions
- Shoulder, Return to Sport, Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 15 Sep 2021 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Operated athletes | Experimental | Other: Strength, range of motion and functional tests + Questionnaire |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with other pathologies that interfere with planned physical activity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strength, range of motion and functional tests + QuestionnairePatients 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. | Other | Operated athletes |
Primary outcome
Strength test
Time frame: 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.
Range of motion
Time frame: 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.
Functional test
Time frame: 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.
Questionnaire DASH
Time frame: 6 months from the surgery
The questionnaire that athletes will complete will be the DASH (Disabilities of the Arm, Shoulder and Hand Scale) questionnaire.
Follow-up questionnaire at 12 months
Time frame: 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.
Follow-up questionnaire at 18 months
Time frame: 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.
Follow-up questionnaire at 24 months
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Strength, range of motion and functional tests + Questionnaire in people with Shoulder and Return to Sport, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amandine Gofflot (+3243662193, agofflot@uliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Strength test (time frame: 6 months from the surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.