- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04992806
A Retrospective Study on the Effect of Surgery on Hip Diseases
July 29, 2021 updated by: Peking University Third Hospital
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.
Study Overview
Status
Enrolling by invitation
Intervention / Treatment
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 Type
Observational
Enrollment (Anticipated)
600
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
-
-
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Beijing, China, 100083
- Peking University Third Hospital
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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
15 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of hip surgery, hip osteoarthritis, femoral head necrosis, hip infection, rheumatic disease, lumbar disease, ankylosing spondylitis, or 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
- Observational Models: Other
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
patients accepted hip arthroscopy
patients with hip diseases and accepted hip arthroscopy in Peking University Third Hospital
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The patient was followed up at 1 year after surgery to evaluate the Visual Analog Scale (VAS).
Time Frame: 1 year after operation
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Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
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1 year after operation
|
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The patient was followed up at 2 years after surgery to evaluate the Visual Analog Scale (VAS).
Time Frame: 2 years after operation
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Visual Analog Scale (VAS), The highest score was 10, and the lowest was 0. The higher the score, the more obvious the pain.
|
2 years after operation
|
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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.
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5 years after operation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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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.
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1 year after operation
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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 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.
|
2 years after operation
|
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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 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.
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5 years after operation
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The patient was followed up at 1 year after surgery to evaluate modified Harris Hip Score (mHHS).
Time Frame: 1 year after operation
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Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
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1 year after operation
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The patient was followed up at 2 years after surgery to evaluate modified Harris Hip Score (mHHS).
Time Frame: 2 years after operation
|
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
|
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
|
Modified Harris Hip Score (mHHS).The highest score was 44, and the lowest was 0. The higher the score, the better the postoperative recovery.
|
5 years after operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: yan xu, Peking University Third Hospital
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)
June 1, 2020
Primary Completion (Actual)
December 1, 2020
Study Completion (Anticipated)
December 1, 2021
Study Registration Dates
First Submitted
June 27, 2021
First Submitted That Met QC Criteria
July 29, 2021
First Posted (Actual)
August 5, 2021
Study Record Updates
Last Update Posted (Actual)
August 5, 2021
Last Update Submitted That Met QC Criteria
July 29, 2021
Last Verified
June 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00006761-2016015
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.
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