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

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.

Study Overview

• Status: Completed
• Conditions: Femoroacetabular Impingement
• Intervention / Treatment: Device: ultrasound evaluation

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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100191
      • Peking Univesity Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group. Inclusion Criteria included patients with hip pain; Cam type (alpha Angle > 50°) impingement and glenoid labrum laceration.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ultrasonic and c-arm combination group; Ultrasound and c-arm were combined to evaluate intraoperatively conditions	Device: ultrasound evaluation; According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group.
c-arm group; c-arm group was used to evaluate intraoperatively conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Hip CT	Routine postoperative hip CT was used to understand the joint morphology.	1 day after operation
Hip X-ray	Routine hip X-ray at the Dunn position was conducted.	1 day after operation

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Principal Investigator: Cui Ligang, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: July 18, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 18, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Joint Diseases; Musculoskeletal Diseases; Femoracetabular Impingement
• Other Study ID Numbers: M2019453

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No