Femoroacetabular ImpingementNCT04992806
A Retrospective Study on the Effect of Surgery on Hip Diseases
An observational study of Femoroacetabular Impingement and Acetabular Labral Tear, run by Peking University Third Hospital at 1 site in China.
Trial summary
To study the effect of arthroscopy on the treatment of hip diseases and to evaluate the regularity and treatment of hip joint diseases. Read more about this study
- Who is it for?
- Ages 15 to 70 years
- Conditions the study is for
- Femoroacetabular Impingement, Acetabular Labral Tear
- What is being tested?
- hip arthroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2020to 1 Dec 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: We evaluated consecutive patients who were diagnosed with hip diseases (i.e. FAI, Acetabulum labrum tear) and who underwent hip arthroscopy at our hospital between January 2011 and January 2016.
Who may be able to join
- The patient received imaging examination before surgery and was diagnosed with hip joint labrum injury, FAI and other hip joint diseases, and the patient complained of pain in the hip joint, buttocks or thigh. Conservative treatment is ineffective for more than 6 months.
Who cannot join
- History of hip surgery, hip osteoarthritis, femoral head necrosis, hip infection, rheumatic disease, lumbar disease, ankylosing spondylitis, or sacroiliac joint disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study on the Effect of Arthroscopy on Hip Diseases
To study the effect of arthroscopy on the treatment of hip diseases and to evaluate the regularity and treatment of hip joint diseases.
Read the detailed description
To study the clinical effect of arthroscopic treatment in patients with hip disease, a retrospective study was conducted on 600 patients with hip disease from January 2011 to January 2016. All patients underwent preoperative examinations. These included preoperative supine anteroposterior hip radiographs, cross-lateral radiographs, computed tomography (CT), and magnetic resonance imaging.Preoperative patient-reported outcomes (PROs), including visual analogue scale (VAS), international hip prognostic instrument-12 (IHOT-12), and modified Harris hip score (MHHS), were evaluated at 1, 2, and 5 years after surgery.
- Being tested
- hip arthroscopy
- 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
Use epidural anesthesia or general anesthesia. The patient lies on the orthopedic traction bed to protect the perineum and perform traction of the lower limbs on the surgical side. Under arthroscopy, check the labrum, acetabular articular surface and femoral head cartilage, and round ligament in turn. The acetabular labrum with tear degeneration was treated with labrum suture or labrum revision surgery according to the injury. Perform femoral head and neck plastic or acetabular plastic surgery, osteoid osteoma debridement, etc.
| Study group | Role | What they receive |
|---|---|---|
| patients accepted hip arthroscopy | patients with hip diseases and accepted hip arthroscopy in Peking University Third Hospital Receives: Procedure: hip arthroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS).
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
Measured: 1 year after operation
The patient was followed up at 2 years after surgery to evaluate the Visual Analog Scale (VAS).
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
Measured: 2 years after operation
The patient was followed up at 5 years after surgery to evaluate the Visual Analog Scale (VAS).
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
Measured: 5 years after operation
Secondary outcomes (6)
The patient was followed up at 1 year after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 1 year after operation
The patient was followed up at 2 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 2 years after operation
The patient was followed up at 5 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
The International Hip Outcome Tool-12 (iHOT-12).The highest score was 120, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 5 years after operation
The patient was followed up at 1 year after surgery to evaluate modified Harris Hip Score (mHHS).
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 1 year after operation
The patient was followed up at 2 years after surgery to evaluate modified Harris Hip Score (mHHS).
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 2 years after operation
The patient was followed up at 5 years after surgery to evaluate modified Harris Hip Score (mHHS).
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
Measured: 5 years after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jun 2020
- Primary completion1 Dec 2020
- Study completion1 Dec 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
- Retrospective
- Enrolment
- 600 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
- NCT04992806
- Sponsor's protocol ID
- IRB00006761-2016015
- Status last verified
- Jun 2021
- First submitted
- 27 Jun 2021
- Last updated
- 5 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 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study on the Effect of Arthroscopy on Hip Diseases
- ClinicalTrials.gov ID
- NCT04992806
- Acronym / sponsor ID
- IRB00006761-2016015
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 5 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.
To study the effect of arthroscopy on the treatment of hip diseases and to evaluate the regularity and treatment of hip joint diseases.
Detailed description
To study the clinical effect of arthroscopic treatment in patients with hip disease, a retrospective study was conducted on 600 patients with hip disease from January 2011 to January 2016. All patients underwent preoperative examinations. These included preoperative supine anteroposterior hip radiographs, cross-lateral radiographs, computed tomography (CT), and magnetic resonance imaging.Preoperative patient-reported outcomes (PROs), including visual analogue scale (VAS), international hip prognostic instrument-12 (IHOT-12), and modified Harris hip score (MHHS), were evaluated at 1, 2, and 5 years after surgery.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients accepted hip arthroscopy | – | Procedure: hip arthroscopypatients with hip diseases and accepted hip arthroscopy in Peking University Third Hospital |
Who may qualify
- Ages
- 15 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- We evaluated consecutive patients who were diagnosed with hip diseases (i.e. FAI, Acetabulum labrum tear) and who underwent hip arthroscopy at our hospital between January 2011 and January 2016.
Key inclusion criteria (1 listed)
- The patient received imaging examination before surgery and was diagnosed with hip joint labrum injury, FAI and other hip joint diseases, and the patient complained of pain in the hip joint, buttocks or thigh. Conservative treatment is ineffective for more than 6 months.
Key exclusion criteria (1 listed)
- History of hip surgery, hip osteoarthritis, femoral head necrosis, hip infection, rheumatic disease, lumbar disease, ankylosing spondylitis, or 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 arthroscopyUse epidural anesthesia or general anesthesia. The patient lies on the orthopedic traction bed to protect the perineum and perform traction of the lower limbs on the surgical side. Under arthroscopy, check the labrum, acetabular articular surface and femoral head cartilage, and round ligament in turn. The acetabular labrum with tear degeneration was treated with labrum suture or labrum revision surgery according to the injury. Perform femoral head and neck plastic or acetabular plastic surgery, osteoid osteoma debridement, etc. | Procedure or surgery | patients accepted hip arthroscopy |
Primary outcome
The patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS).
Time frame: 1 year after operation
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
The patient was followed up at 2 years after surgery to evaluate the Visual Analog Scale (VAS).
Time frame: 2 years after operation
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
The patient was followed up at 5 years after surgery to evaluate the Visual Analog Scale (VAS).
Time frame: 5 years after operation
Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
6 secondary outcomes
The patient was followed up at 1 year after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time frame: 1 year after operation
The patient was followed up at 2 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time frame: 2 years after operation
The patient was followed up at 5 years after surgery to evaluate the International Hip Outcome Tool-12 (iHOT-12).
Time frame: 5 years after operation
The patient was followed up at 1 year after surgery to evaluate modified Harris Hip Score (mHHS).
Time frame: 1 year after operation
The patient was followed up at 2 years after surgery to evaluate modified Harris Hip Score (mHHS).
Time frame: 2 years after operation
The patient was followed up at 5 years after surgery to evaluate modified Harris Hip Score (mHHS).
Time frame: 5 years after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 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 and Acetabular Labral Tear, 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 5 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 patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS). (time frame: 1 year after operation). The study lists 3 primary outcomes in all. 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 5 Aug 2021.