The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping

Completed

• Conditions: Femoroacetabular Impingement
• Interventions: Device: ultrasound evaluation

• Registration Number: NCT04980209
• Lead Sponsor: Peking University Third Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-05-01
• Study Completion: 2019-12-01
• Status Verified: 2021-06
• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-07-18
• Last Update Submitted: 2021-07-18
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Patients with hip pain;
• Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration

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Exclusion Criteria

• Previous hip surgery;
• Patients with subosseous cystic degeneration of synovitis

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasonic and c-arm combination group	ultrasound evaluation	Ultrasound and c-arm were combined to evaluate intraoperatively conditions

Primary Outcome Measures

Name	Time	Method
VAS scale	1 year after operation	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.
MHHS scale	1 year after operation	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.
Hip CT	1 day after operation	Routine postoperative hip CT was used to understand the joint morphology.
Hip X-ray	1 day after operation	Routine hip X-ray at the Dunn position was conducted.

Trial Locations

Locations (1)

Peking Univesity Third Hospital; 🇨🇳 Beijing, Beijing, China