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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)

Primary Purpose

Femoroacetabular Impingement

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Functional Tests
Sponsored by
Ramsay Générale de Santé
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Femoroacetabular Impingement focused on measuring femoroacetabular Impingement, Reproducibility of strength testing and functional testing

Eligibility Criteria

16 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Centre SantyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Healthy Volunteers

Patients Volunteers

Arm Description

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.

To answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart.

Outcomes

Primary Outcome Measures

Reproducibility rate
intra- and inter-session reproducibility

Secondary Outcome Measures

Full Information

First Posted
May 20, 2022
Last Updated
May 20, 2022
Sponsor
Ramsay Générale de Santé
Collaborators
Ramsay santé
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1. Study Identification

Unique Protocol Identification Number
NCT05391204
Brief 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
Acronym
H-Repro
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
January 31, 2023 (Anticipated)
Study Completion Date
January 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
Ramsay santé

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoroacetabular Impingement
Keywords
femoroacetabular Impingement, Reproducibility of strength testing and functional testing

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients Volunteers
Arm Type
Experimental
Arm Description
To answer the question of reproducibility of the measurement (1st objective), half the group patient will perform two examinations at two months apart.
Intervention Type
Other
Intervention Name(s)
Functional Tests
Intervention Description
Various physical exercices of inferior members
Primary Outcome Measure Information:
Title
Reproducibility rate
Description
intra- and inter-session reproducibility
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
JF ECTEN
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
MH BARBA
Phone
0664888704
Email
mh.barba@ecten.eu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu THAUNAT, Dr
Organizational Affiliation
Centre santy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Santy
City
Lyon
State/Province
Aura
ZIP/Postal Code
69000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mathieu THAUNAT, DR
Phone
0437530703
Email
mathieuthaunat@yahoo.fr
First Name & Middle Initial & Last Name & Degree
Isabelle ROGOWSKI,
Email
abelle.rogowski@univ-lyon1.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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