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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04980209
Other study ID # M2019453
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2018
Est. completion date December 1, 2019

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 assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.


Description:

Ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. The study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.


Recruitment information / eligibility

Status Completed
Enrollment 78
Est. completion date December 1, 2019
Est. primary completion date May 1, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients with hip pain; - Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration Exclusion Criteria: - Previous hip surgery; - Patients with subosseous cystic degeneration of synovitis

Study Design


Intervention

Device:
ultrasound evaluation
According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group.

Locations

Country Name City State
China Peking Univesity Third Hospital Beijing 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 VAS scale Visual analogue scale(VAS)was used to measure the pain score. The minimum and maximum values were 0 and 10. The higher score, the worse pain. 1 year after operation
Primary MHHS scale Modified Harris Hip Score (MHHS) scale was used to measure the symptoms of joint. The minimum and maximum values were 0 and 91. The higher score, the better. 1 year after operation
Primary Hip CT Routine postoperative hip CT was used to understand the joint morphology. 1 day after operation
Primary Hip X-ray Routine hip X-ray at the Dunn position was conducted. 1 day after operation
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