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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04992806
Other study ID # IRB00006761-2016015
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 1, 2020
Est. completion date December 1, 2021

Study information

Verified date June 2021
Source Peking University Third Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 600
Est. completion date December 1, 2021
Est. primary completion date December 1, 2020
Accepts healthy volunteers No
Gender All
Age group 15 Years to 70 Years
Eligibility 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 Design


Intervention

Procedure:
hip arthroscopy
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.

Locations

Country Name City State
China Peking University Third Hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 1 year after operation
Primary 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. 2 years after operation
Primary 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. 5 years after operation
Secondary 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. 1 year after operation
Secondary 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. 2 years after operation
Secondary 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. 5 years after operation
Secondary 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. 1 year after operation
Secondary 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. 2 years after operation
Secondary 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. 5 years after operation
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