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Completed

NCT Number: NCT06833242

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.

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Key information

Conditions

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Medical Center of the PLA General Hospital

Beijing, 100036, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. The final success rate

    Time frame: during operation

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

Secondary outcomes

  1. Puncture time

    Time frame: during operation

    The duration from the insertion of the puncture needle into the skin until saline can be injected into the joint cavity without significant resistance

  2. The number of needle adjustments

    Time frame: during operation

    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

  3. The operator confidence score

    Time frame: during operation

    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

  4. Complications

    Time frame: during operation

    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

Sponsors and collaborators

Lead sponsor

Yi Mao

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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