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

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.

Study Overview

• Status: Completed
• Conditions: Hip Pain
• Intervention / Treatment: Device: Real-time 3D Xplane ultrasound

Detailed Description

Real-time biplane imaging, an emerging ultrasound technology, uses a three-dimensional (3D) matrix transducer to display simultaneously he longitudinal and transverse intersecting planes on a single screen without requiring rotation of the transducer. The modality displays the puncture path in real-time and exhibits the spatial relationship between the needle tip and the target site, as well as surrounding structures during guided puncture. This technology significantly improves the puncture success rate and reduces complication rates in procedures such as the placement of intrahepatic bile duct drains and central venous catheters. However, this technology has not yet been implemented for hip joint injections. Therefore, we compared the safety and accuracy of single-plane and real-time biplane ultrasound imaging in guiding hip joint injections and explored the application effects of imaging technology in hip joint injections.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100036
    • The First Medical Center of the PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1.15 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The real-time biplane ultrasound guidance group; 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; 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.
No Intervention: The single-plane ultrasound guidance group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Puncture time	The duration from the insertion of the puncture needle into the skin until saline can be injected into the joint cavity without significant resistance	during operation
The number of needle adjustments	The number of times the puncture needle was retracted slightly and the insertion direction was adjusted upon noticing that the needle tip had deviated from the intended trajectory	during operation
The operator confidence score	Based on the operator's level of confidence during the puncture process, with 1 point indicating a lack of confidence in the success of the first attempt, 2 points indicating moderate confidence, and 3 points indicating strong confidence	during operation
Complications	Refer to adverse reactions occurring during the puncture process, including hematomas resulting from damage to surrounding blood vessels, pain or numbness due to nerve injury, toxic reactions caused by anesthetic entering the bloodstream, and postoperative infections	during operation

Collaborators and Investigators

• Sponsor: Yi Mao
• Investigators: Study Chair: Mingbo Zhang, Chinese PLA General Hospital; Study Director: Guozheng Zhao, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: February 13, 2025
• First Submitted That Met QC Criteria: February 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 13, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Injection; Hip Joint; Puncture; Single-plane; Real-time biplane
• Other Study ID Numbers: ChinaPLAGH20250213

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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