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

• Sponsor: Peking University Third Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT04980209
• Collaborator: (none)
• Enrollment: 78
• Location: 1
• Actual Duration (Months): 19
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Femoroacetabular Impingement	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 Design

• Study Type: Observational
• Actual Enrollment: 78 participants
• Observational Model: Case-Control
• Time Perspective: Cross-Sectional
• Official Title: The Feasibility and Application of Intraoperative Ultrasound to Evaluate Femoral Head Shaping
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: Dec 1, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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.

3. Hip CT [1 day after operation]

   Routine postoperative hip CT was used to understand the joint morphology.

4. Hip X-ray [1 day after operation]

   Routine hip X-ray at the Dunn position was conducted.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking Univesity Third Hospital	Beijing	Beijing	China	100191

Sponsors and Collaborators

• Peking University Third Hospital

Investigators

• Principal Investigator: Cui Ligang, Peking University Third Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Cui Ligang, Chief Physician, Peking University Third Hospital
• ClinicalTrials.gov Identifier: NCT04980209
• Other Study ID Numbers: M2019453
• First Posted: Jul 28, 2021
• Last Update Posted: Jul 28, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Femoracetabular Impingement

Study Results

No Results Posted as of Jul 28, 2021