Femoroacetabular ImpingementNCT04988659
Analysis of Gene Expression in Femoroacetabular Impingement (FAI)
An observational study of Femoroacetabular Impingement, run by Peking University Third Hospital at 1 site in China.
Trial summary
Femoral acetabular impingement (FAI) is a common disease of the hip joint. In this study, whole-genome sequencing was used to further explore the pathogenesis of this disease. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Femoroacetabular Impingement
- What is being tested?
- Exposures
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 30 Mar 2021to 30 Sep 2021
- 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 15 to 70 years
- All sexes
- Child, Adult, Older adult
Study population: Both patients were from Peking University Third Hospital and were diagnosed as Femoroacetabular impingement syndrome.
Who may be able to join
- The patient underwent preoperative imaging and was diagnosed with FAI. The patient complained of pain in the hip, hip, or thigh, and had a positive hip flexion impact test.
Who cannot join
- Patients with hip surgery history, hip osteoarthritis, necrosis of the femoral head, hip infection, hip dysplasia and other hip diseases.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Total Exon Association Analysis of Femoroacetabular Impingement (FAI)
Femoral acetabular impingement (FAI) is a common disease of the hip joint. In this study, whole-genome sequencing was used to further explore the pathogenesis of this disease.
Read the detailed description
Femoral acetabular impingement (FAI) is a group of chronic hip pain caused by the impact between the proximal femur and the edge of the acetabulum due to the anatomical abnormality of the hip joint, which damages the labrum and adjacent cartilage, and causes limited hip movement, especially limited flexion and internal rotation. However, the specific etiology of FAI is still unknown at present. The application of genome-wide, exon and transcription research methods to the study of hip impaction syndrome can uncover key differentially expressed genes and provide a theoretical basis for the study of FAI.
- Conditions
- Femoroacetabular Impingement
- Being tested
- Exposures
- Medical subject headings
- Femoracetabular Impingement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposuresOther
Exposures
What is being measured
The primary outcome is the main question the study is designed to answer.
The patients were clinically diagnosed with FAI (femoral acetabular impingement) and underwent arthroscopic surgery, then clinical samples were collected.
Peripheral blood from 100 patients with femoral acetabular impingement syndrome was collected and DNA was extracted.
Measured: The patient was diagnosed with FAI, and conservative treatment was ineffective for an average of 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start30 Mar 2021
- Primary completion30 May 2021
- Study completion30 Sep 2021 (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 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- yan xu, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988659
- Sponsor's protocol ID
- M2020533
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 3 Aug 2021
- Results posted
- 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 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Total Exon Association Analysis of Femoroacetabular Impingement (FAI)
- ClinicalTrials.gov ID
- NCT04988659
- Acronym / sponsor ID
- M2020533
- Conditions
- Femoroacetabular Impingement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 3 Aug 2021 (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.
Femoral acetabular impingement (FAI) is a common disease of the hip joint. In this study, whole-genome sequencing was used to further explore the pathogenesis of this disease.
Detailed description
Femoral acetabular impingement (FAI) is a group of chronic hip pain caused by the impact between the proximal femur and the edge of the acetabulum due to the anatomical abnormality of the hip joint, which damages the labrum and adjacent cartilage, and causes limited hip movement, especially limited flexion and internal rotation. However, the specific etiology of FAI is still unknown at present. The application of genome-wide, exon and transcription research methods to the study of hip impaction syndrome can uncover key differentially expressed genes and provide a theoretical basis for the study of FAI.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Both patients were from Peking University Third Hospital and were diagnosed as Femoroacetabular impingement syndrome.
Key inclusion criteria (1 listed)
- The patient underwent preoperative imaging and was diagnosed with FAI. The patient complained of pain in the hip, hip, or thigh, and had a positive hip flexion impact test.
Key exclusion criteria (1 listed)
- Patients with hip surgery history, hip osteoarthritis, necrosis of the femoral head, hip infection, hip dysplasia and other hip diseases.
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 |
|---|---|---|
| ExposuresExposures | Other | – |
Primary outcome
The patients were clinically diagnosed with FAI (femoral acetabular impingement) and underwent arthroscopic surgery, then clinical samples were collected.
Time frame: The patient was diagnosed with FAI, and conservative treatment was ineffective for an average of 6 months.
Peripheral blood from 100 patients with femoral acetabular impingement syndrome was collected and DNA was extracted.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Individual participant dataSharing planned: No
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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.
yan xu principal investigator
Peking University Third Hospital
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 Femoroacetabular Impingement, 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: status not confirmed, as of the sponsor's last update on 3 Aug 2021. 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?
Results are not available in the source record.
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?
The patients were clinically diagnosed with FAI (femoral acetabular impingement) and underwent arthroscopic surgery, then clinical samples were collected. (time frame: The patient was diagnosed with FAI, and conservative treatment was ineffective for an average of 6 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 3 Aug 2021.