Hip PainNCT06833242
Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study
A study testing Real-time 3D Xplane ultrasound in people with Hip Pain, run by Yi Mao at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 80 years
- Conditions the study is for
- Hip Pain
- What is being tested?
- Real-time 3D Xplane ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Medical Center of the PLA General Hospital
Beijing, 100036
About this 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.
Read the 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.
- Conditions
- Hip Pain
- Being tested
- Real-time 3D Xplane ultrasound
- Keywords
- Hip Joint, Puncture, Injection, Single-plane, Real-time biplane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real-time 3D Xplane ultrasoundDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during operation
The final success rate
The proportion of successful medication injections completed with no more than two needle insertions
Measured: during operation
Secondary outcomes (4)
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
Measured: 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
Measured: 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
Measured: 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
Measured: during operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yi Mao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Mao, Chinese PLA General Hospital
- Investigators
- Mingbo Zhang, Study chair, Chinese PLA General HospitalGuozheng Zhao, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06833242
- Sponsor's protocol ID
- ChinaPLAGH20250213
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2025
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-plane Versus Real-time Biplane Approaches for Ultrasound-Guided Hip Joint Injection: A Prospective Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06833242
- Acronym / sponsor ID
- ChinaPLAGH20250213
- Conditions
- Hip Pain
- Keywords
- Hip Joint, Puncture, Injection, Single-plane, Real-time biplane
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Yi MaoUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 18 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The real-time biplane ultrasound guidance group | Experimental | Device: Real-time 3D Xplane ultrasoundFor 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). |
| 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) |
Who may qualify
- Ages
- 15 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real-time 3D Xplane ultrasoundAfter 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. | Device | The real-time biplane ultrasound guidance group |
Primary outcome
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
4 secondary outcomes
Puncture time
Time frame: during operation
The number of needle adjustments
Time frame: during operation
The operator confidence score
Time frame: during operation
Complications
Time frame: during operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mingbo Zhang study chair
Chinese PLA General Hospital
Guozheng Zhao study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real-time 3D Xplane ultrasound in people with Hip Pain, run by Yi Mao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The first-attempt success rate (time frame: during operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.