Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The first-attempt success rate
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Masking Description
There are practical differences in operation and blind methods cannot be achieved.
Eligibility Criteria
- Ages
- 15 Years to 80 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Arms & Interventions
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).
Intervention: Real-time 3D Xplane ultrasound (Device)
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)
Outcomes
Primary Outcomes
The first-attempt success rate
Time Frame: during operation
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
The final success rate
Time Frame: during operation
The proportion of successful medication injections completed with no more than two needle insertions
Secondary Outcomes
- Puncture time(during operation)
- The number of needle adjustments(during operation)
- The operator confidence score(during operation)
- Complications(during operation)
Investigators
Yi Mao
clinician
Chinese PLA General Hospital