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

Femoroacetabular Impingement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980209
• Other study ID #: M2019453
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Femoracetabular Impingement
• Femoroacetabular Impingement

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