- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04454021
Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy
June 30, 2020 updated by: Peking University Third Hospital
The purpose of this study was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
We performed a retrospective review of magnetic resonance imaging (MRI) data of FAI patients who underwent hip arthroscopy between January 1, 2016, and July 1, 2018.
"Image J" with an embedded region-of-interest (ROI) tool was used to calculate the cross-sectional area (CSA) of muscles on MRI.
Wilcoxon signed-rank test was used to determine the differences between preoperative and postperative hip muscle CSA.
The correlations of change in muscle CSA with age, gender, BMI, pain level, preoperative symptom duration, and multiple validated patient-reported outcomes were also analyzed with a spearman rank correlation test.
Study Type
Observational
Enrollment (Actual)
51
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Haidian District
-
Beijing, Haidian District, China, 100191
- Jianquan Wang
-
-
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
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI
Description
Inclusion Criteria:
- (1) Age 18-50 years; (2) symptoms, physical examination, imaging evidence in accordance with FAI; (3) symptoms that were not alleviated by nonsurgical treatment; (4) the operation is performed by the same senior operator.
Exclusion Criteria:
- (1) bilateral symptoms; (2) revision surgery; (3) advanced osteoarthritis; (4) acetabular dysplasia; (5) history of hip and knee joint disease and operation; (6) osteonecrosis of hip; (7) sacroiliac joint disease
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle volume after hip arthroscopy
Time Frame: at least two years after hip arthroscopy
|
hip muscle cross-sectional area of patients with unilateral FAI
|
at least two years after hip arthroscopy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 10, 2020
Primary Completion (ACTUAL)
March 10, 2020
Study Completion (ACTUAL)
March 10, 2020
Study Registration Dates
First Submitted
June 28, 2020
First Submitted That Met QC Criteria
June 30, 2020
First Posted (ACTUAL)
July 1, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 1, 2020
Last Update Submitted That Met QC Criteria
June 30, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- wjqsportsmed163
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.
Clinical Trials on Femoro-acetabular Impingement (FAI)
-
GCS Ramsay Santé pour l'Enseignement et la RechercheNot yet recruiting
-
Cambridge University Hospitals NHS Foundation TrustUnknown
-
Bezirkskrankenhaus St. Johann in TirolCompletedHip Disease | Hip Impingement Syndrome | Femoro-acetabular ImpingementAustria
-
University of UtahEnrolling by invitationFemoro Acetabular ImpingementUnited States
-
Horsens HospitalCompletedFemoro Acetabular ImpingementDenmark
-
Panam ClinicRecruitingFemoro Acetabular ImpingementCanada
-
Reinier Haga Orthopedisch CentrumNot yet recruiting
-
Nova Scotia Health AuthorityEnrolling by invitationFemoro Acetabular ImpingementCanada
-
Peking University Third HospitalCompleted
-
Cedars-Sinai Medical CenterCompletedFemoro Acetabular ImpingementUnited States
Clinical Trials on hip arthroscopy
-
Ottawa Hospital Research InstituteRecruitingHip DysplasiaCanada, United States
-
Aarhus University HospitalCompletedDevelopmental Dysplasia of the Hip
-
Sharp HealthCareUnknown
-
Yale UniversityArthrex, Inc.RecruitingFemoroacetabular Impingement | Hip ArthroscopyUnited States
-
Clinique de la SauvegardeCompletedFemoral Acetabular ImpingementFrance
-
Bezirkskrankenhaus St. Johann in TirolCompletedHip Disease | Hip Impingement Syndrome | Femoro-acetabular ImpingementAustria
-
Horsens HospitalCompletedFemoro Acetabular ImpingementDenmark
-
University of Colorado, DenverCompletedHip DiseaseUnited States
-
Istituto Ortopedico RizzoliWithdrawn