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

NCT04980209 | Completed

• 1 other identifier: M2019453
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoroacetabular Impingement

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Ultrasonic and c-arm combination group

Ultrasound and c-arm were combined to evaluate intraoperatively conditions

Device: ultrasound evaluation

c-arm group

c-arm group was used to evaluate intraoperatively conditions

Interventions

ultrasound evaluation DEVICE

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

Ultrasonic and c-arm combination group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking Univesity Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

Femoracetabular Impingement

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Cui Ligang

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: July 28, 2021
• Study Start: May 1, 2018
• Primary Completion: May 1, 2019
• Study Completion: December 1, 2019
• Last Updated: July 28, 2021

Record last verified: 2021-06

Locations

CN (1)