- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05391204
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 (H-Repro)
May 20, 2022 updated by: Ramsay Générale de Santé
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: JF ECTEN
- Phone Number: 0683346567
- Email: jf.oudet@ecten.eu
Study Contact Backup
- Name: MH BArba
- Phone Number: 0664888704
- Email: MH.Barba@ecten.eu
Study Locations
-
-
Aura
-
Lyon, Aura, France, 69000
- Recruiting
- Centre Santy
-
Contact:
- Mathieu THAUNAT, DR
- Phone Number: 0437530703
- Email: mathieuthaunat@yahoo.fr
-
Contact:
- Isabelle ROGOWSKI,
- Email: abelle.rogowski@univ-lyon1.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 50 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
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°
- 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
Exclusion Criteria:
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy Volunteers
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.
|
Various physical exercices of inferior members
|
Experimental: Patients Volunteers
To answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart.
|
Various physical exercices of inferior members
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reproducibility rate
Time Frame: 8 months
|
intra- and inter-session reproducibility
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Mathieu THAUNAT, Dr, Centre Santy
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 20, 2020
Primary Completion (Anticipated)
January 31, 2023
Study Completion (Anticipated)
January 31, 2023
Study Registration Dates
First Submitted
May 20, 2022
First Submitted That Met QC Criteria
May 20, 2022
First Posted (Actual)
May 25, 2022
Study Record Updates
Last Update Posted (Actual)
May 25, 2022
Last Update Submitted That Met QC Criteria
May 20, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-A01382-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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-
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-
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