Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study

NCT06833242 | Completed

• 1 other identifier: ChinaPLAGH20250213
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to compare the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explore the application effects of imaging technology in hip joint injections.

Conditions

Hip Pain

Keywords

Hip Joint; Puncture; Injection; Single-plane; Real-time biplane

Outcome Measures

Primary Outcomes (2)

• The first-attempt success rate

  The proportion of successful entries into the anterior synovial recess and completion of medication injection on the first needle insertion, without adjusting needle tip direction

  during operation

• The final success rate

  The proportion of successful medication injections completed with no more than two needle insertions

  during operation

Secondary Outcomes (4)

• Puncture time

  during operation

• The number of needle adjustments

  during operation

• The operator confidence score

  during operation

• Complications

  during operation

Study Arms (2)

The real-time biplane ultrasound guidance group

EXPERIMENTAL

For the real-time biplane ultrasound guidance group, the hip joint injections was performed under the guidance of Xplane ultrasound with a X6-1 volume transducer probe (frequency range 1.0-6.0MHz).

Device: Real-time 3D Xplane ultrasound

The single-plane ultrasound guidance group

NO INTERVENTION

For the single-plane ultrasound guidance group, the hip joint injections was performed under the guidance with a C5-1 convex array transducer (frequency range1.0-5.0 MHz)

Interventions

Real-time 3D Xplane ultrasound DEVICE

After the puncture needle is in the skin, the longitudinal section of the Xplane mode can be adjusted to keep the needle in the proposed plane.

The real-time biplane ultrasound guidance group

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• to 80 years of age; 2.hip joint pain and/or limited hip joint mobility; 3.physical examination and imaging studies indicating hip joint pathology; 4.pain duration exceeding 6 months with no significant improvement after conservative treatment; 5.patients scheduled for hip arthroscopy.

You may not qualify if:

• a history of hip joint surgery;
• the presence of lumbar disease, ankylosing spondylitis, or sacroiliac-joint pathology;
• femoral head necrosis;
• drug allergies;
• inability to cooperate, or other contraindications to puncture.

Sponsors & Collaborators

• Yi Mao: lead

Study Sites (1)

The First Medical Center of the PLA General Hospital

Beijing, 100036, China

Location

Study Officials

• Mingbo Zhang

  Chinese PLA General Hospital

  STUDY CHAIR

• Guozheng Zhao

  Chinese PLA General Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: There are practical differences in operation and blind methods cannot be achieved.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: clinician

Study Record Dates

• First Submitted: February 13, 2025
• First Posted: February 18, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)