Femoro-acetabular Impingement (FAI)NCT04454021
Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy
An observational study of Femoro-acetabular Impingement (FAI), run by Peking University Third Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Femoro-acetabular Impingement (FAI)
- What is being tested?
- hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 51 participants
- Where
- 1 siteChina
- Study dates
- 10 Jan 2020to 10 Mar 2020
- Phase
- Observational
- 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 50 years
- All sexes
- Adult
Study population: patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI
Who may be able to join
- (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.
Who cannot join
- (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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Femoro-acetabular Impingement (FAI)
- Being tested
- hip arthroscopy
- Keywords
- femoro-acetabular impingement, hip muscle volume, cross-sectional area, arthroscopy, MRI images
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hip arthroscopyProcedure or surgery
hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in muscle volume after hip arthroscopy
hip muscle cross-sectional area of patients with unilateral FAI
Measured: at least two years after hip arthroscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start10 Jan 2020
- Primary completion10 Mar 2020
- Study completion10 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoro-acetabular Impingement (FAI)Studies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454021
- Sponsor's protocol ID
- wjqsportsmed163
- Status last verified
- Jun 2020
- First submitted
- 28 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Muscle Volume in Patients With Unilateral Femoro-acetabular Impingement Syndrome After Hip Arthroscopy
- ClinicalTrials.gov ID
- NCT04454021
- Acronym / sponsor ID
- wjqsportsmed163
- Conditions
- Femoro-acetabular Impingement (FAI)
- Keywords
- femoro-acetabular impingement, hip muscle volume, cross-sectional area, arthroscopy, MRI images
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Mar 2020 (actual)
- First posted
- 1 Jul 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 was to investigate the change in muscle volume around the hip in patients with unilateral femoro-acetabular impingement (FAI) after arthroscopy.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- patients who underwent primary hip arthroscopy for the treatment of symptomatic FAI
Key inclusion criteria (1 listed)
- (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.
Key exclusion criteria (1 listed)
- (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
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 |
|---|---|---|
| hip arthroscopyhip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment | Procedure or surgery | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Femoro-acetabular Impingement (FAI)
RecruitingPhase 4
Efficacy of Ketorolac for Postoperative Pain Management in Hip Arthroscopy
Femoracetabular Impingement, Hip Arthroscopy
Not yet recruiting
The Effectiveness of High-intensity Laser Therapy in Femoroacetabular Impingement Syndrome
Femoroacetabular Impingement Syndrome, Femoro-acetabular Impingement
Not yet recruitingObservational study
Mapping Joint Damage Patterns in Femoroacetabular Impingement
Femoro-acetabular Impingement (FAI)
Not yet recruiting
Comparison of Minced Cartilage Implantation Versus Microfracture for Acetabular Chondral Lesions Due to FAI (Femoro-acetabular Impingement)
Femoro-acetabular Impingement (FAI)
Recruiting
Biomechanical Investigation of Symptomatic FAI and Two Groups of Asymptomatic Controls
Femoroacetabular Impingement
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Femoro-acetabular Impingement (FAI), run by Peking University Third Hospital at 1 site in China.
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 1 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: finished, as of the sponsor's last update on 1 Jul 2020. 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 China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in muscle volume after hip arthroscopy (time frame: at least two years after hip arthroscopy). 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 1 Jul 2020.