Femoroacetabular ImpingementH-ReproNCT05391204
Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls
A study testing Functional Tests in people with Femoroacetabular Impingement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at… Read more about this study
- Who is it for?
- Ages 16 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Functional Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Oct 2020to 31 Jan 2023
- 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 16 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Patients
- Male or female aged 16 to 50
- Occurrence of the injury requiring surgery during a sports activity
- Hip arthroscopy
- Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
- Angle Alpha > 55°
Show all 13Show fewer
- Patient having signed an informed consent
- Affiliated subject or beneficiary of a social Security
- Control group
- Male or female aged 16 to 50
- Practicing a regular sporting activity In both groups
- Patient having signed an informed consent
- Affiliated subject or beneficiary of a social Security
Who cannot join
- Patient group
- Contraindication of the surgeon
- Present another pathology of the hip on the side of the operated limb or on the contralateral side
- Control group
- Declare a history of lower limb pain/injury in the last 12 months
- Declare a history of orthopedic surgery on the lower limbs
- In any case will be excluded Protected subject: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Santy
Lyon, AURA, 69000
Mathieu THAUNAT, DR, 0437530703, mathieuthaunat@yahoo.fr
Isabelle ROGOWSKI,, abelle.rogowski@univ-lyon1.fr
About this study
Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.
Read the detailed description
Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Functional Tests
- Keywords
- femoroacetabular Impingement, Reproducibility of strength testing and functional testing
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional TestsOther
Various physical exercices of inferior members
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Active comparator | To answer the question of reproducibility of the measurement (1st objective), half of the group control will carry out two handover of the battery of functional tests to a week apart. Receives: Other: Functional Tests |
| Patients Volunteers | Experimental | To answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart. Receives: Other: Functional Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility rate
intra- and inter-session reproducibility
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start20 Oct 2020
- Primary completion31 Jan 2023 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoroacetabular ImpingementStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There is therefore a lack of specific clinical tests allowing the functional evaluation of the hip. This is why it is necessary to study the possibility of deploying tests evaluating the functional capacities of the lower limb to characterize the functions of the hip. The study will compare patients group versus healthy volunteers and reproducibility.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Ramsay santé
- Responsible party
- Sponsor
- Investigators
- Mathieu THAUNAT, Dr, Principal investigator, Centre santy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391204
- Sponsor's protocol ID
- 2020-A01382-37
- Acronym
- H-Repro
- Status last verified
- Mar 2022
- First submitted
- 20 May 2022
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproducibility of Strength Testing and Functional Testing of the Hip for the Return to Sport of Patients Activated by a Femoroacetabular Impingement: Comparison Between a Group of Patients and a Group of Healthy Controls
- ClinicalTrials.gov ID
- NCT05391204
- Acronym / sponsor ID
- H-Repro / 2020-A01382-37
- Conditions
- Femoroacetabular Impingement
- Keywords
- femoroacetabular Impingement, Reproducibility of strength testing and functional testing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Ramsay santé
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 31 Jan 2023 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 25 May 2022 (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.
Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.
Detailed description
Reproducibility of strength testing and functional testing of the hip for the return to sport of patients activated by a femoroacetabular impingement: comparison between a group of patients and a group of healthy controls Femoroacetabular impingement is a disorder movement-related hip clinic, with bone abnormality at the joint coxo-femoral associated with a triad of symptoms, clinical signs and findings imagery. It represents premature contact symptomatic between the femur and the acetabulum. Currently, there is no consensus for determine when to return to sport securely after processing arthroscopy of a emoroacetabular impingement. Various clinical tests are used to assess the mobility or pain but no test studies specifically the level of recovery functional.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- There is therefore a lack of specific clinical tests allowing the functional evaluation of the hip. This is why it is necessary to study the possibility of deploying tests evaluating the functional capacities of the lower limb to characterize the functions of the hip. The study will compare patients group versus healthy volunteers and reproducibility.
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Active comparator | Other: Functional TestsTo answer the question of reproducibility of the measurement (1st objective), half of the group control will carry out two handover of the battery of functional tests to a week apart. |
| Patients Volunteers | Experimental | Other: Functional TestsTo answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (13 listed)
- Patients
- Male or female aged 16 to 50
- Occurrence of the injury requiring surgery during a sports activity
- Hip arthroscopy
- Surgery performed by surgeons from the Santy Orthopedic Center (Lyon)
Key exclusion criteria (7 listed)
- Patient group
- Contraindication of the surgeon
- Present another pathology of the hip on the side of the operated limb or on the contralateral side
- Control group
- Declare a history of lower limb pain/injury in the last 12 months
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 |
|---|---|---|
| Functional TestsVarious physical exercices of inferior members | Other | Healthy Volunteers, Patients Volunteers |
Primary outcome
Reproducibility rate
Time frame: 8 months
intra- and inter-session reproducibility
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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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.
Mathieu THAUNAT, Dr principal investigator
Centre santy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional Tests in people with Femoroacetabular Impingement, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 13 inclusion and 7 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 25 May 2022. 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 France. 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 JF ECTEN (0683346567, jf.oudet@ecten.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reproducibility rate (time frame: 8 months). 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 25 May 2022.