Imaging Techniques for Hip Surgery Assessment

Overseen By Ashley Burke

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Revision hip, Ipsilateral knee, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two imaging methods, CT scans (Computed Tomography) and handheld ultrasound, to assess muscle quality in patients needing hip replacement surgery. It focuses on measuring the muscle area and fat content within the thigh muscle to better understand muscle health. The trial uses standard CT scans and ultrasound scans to determine if ultrasound can provide a safe, repeatable alternative. Individuals scheduled for their first hip replacement surgery are suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to research that could enhance imaging techniques for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these imaging techniques are safe for hip surgery assessment?

Research has shown that ultrasound safely examines the hip joint without using X-rays, eliminating exposure to potentially harmful radiation. This makes it suitable for repeated use. Studies have found that ultrasound is often used for hip procedures like fluid removal and injections, and patients generally tolerate it well.

Conversely, CT scans involve radiation but remain a common component of many medical evaluations, including those for the hip. This trial includes CT scans as part of standard care, which is generally considered safe despite the radiation exposure.

In summary, ultrasound offers a safer option regarding radiation exposure. Both ultrasound and CT scans are widely used in healthcare and play important roles in patient care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring how ultrasound, in combination with standard CT scans, can improve hip surgery assessments. Unlike traditional methods that rely solely on CT scans, ultrasound offers a radiation-free alternative, potentially enhancing patient safety. This trial aims to find out if combining ultrasound with CT scans can provide more detailed imaging, leading to better surgical outcomes. Additionally, ultrasound is a non-invasive, cost-effective tool that can be performed quickly, which might streamline the pre-surgery process. Overall, the trial could pave the way for more accurate, safer, and efficient hip surgery planning.

What evidence suggests that these imaging techniques are effective for assessing hip surgery?

This trial will compare the effectiveness of different imaging techniques for assessing hip surgery. Participants in one arm will receive a standard CT scan before primary hip replacement, while those in another arm will receive both ultrasound scans and the standard CT. Studies have shown that ultrasound is a useful tool for examining the hip area. It can be almost as effective as an MRI for detecting problems after hip replacement surgery. Research suggests that ultrasound surpasses regular X-rays in evaluating mild hip arthritis. It is safe, uses no harmful radiation, and can be performed frequently if needed. Although ultrasound might not detect everything, such as certain fluid issues in the hip joint, it remains helpful for many hip evaluations. This makes it a promising method for measuring muscle quality and fat content in the thigh muscle for patients undergoing hip surgery. ^{6 7 8 9 10}

Who Is on the Research Team?

David MacLeod

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

This trial is for patients scheduled for primary hip replacement surgery. It aims to compare muscle quality assessments using two different imaging techniques: CT scans and handheld ultrasound.

Inclusion Criteria

I have had a hip replacement surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo both CT and MSK ultrasound imaging to measure intramuscular adipose tissue (IMAT) and muscle area

1 hour

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT
• HIP: Hip Imaging Protocol
• Ultrasound

Trial Overview The study is testing the effectiveness of musculoskeletal (MSK) ultrasound against standard CT imaging in measuring muscle area and fat within muscles (IMAT) in the thigh, specifically in patients undergoing hip arthroplasty.

How Is the Trial Designed?

Group I: Ultrasound Experimental Treatment 1 Intervention

Patients have ultrasound scans together with standard of care CT prior to primary hip replacement

Group II: CT Active Control 1 Intervention

Patients have standard of care CT prior to primary hip replacement

CT is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Approved in United States as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Approved in Canada as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Approved in Japan as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Approved in China as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Approved in Switzerland as Computed Tomography for:

• Diagnostic imaging for various medical conditions

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Published Research Related to This Trial

Digital tomographic fusion imaging (DTS) significantly outperformed digital X-ray (DR) in detecting avascular necrosis of the femoral head, with a higher detection rate among the 82 adult patients studied.

DTS offers high sensitivity and specificity, making it a valuable diagnostic tool that can reduce the need for more expensive CT and MRI scans, thus conserving medical resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical value of digital tomographic fusion imaging in the diagnosis of avascular necrosis of the femoral head in adults. Zhang, J., Wang, Z., Hong, G.[2022]

In a study of 26 children with Legg-Calvé-Perthes disease (LCPD) and 25 asymptomatic hips, specific sonographic scanning planes, particularly the coronal and 30 degrees abduction approaches, were found to be more effective in detecting vascularity in pathologic hips compared to asymptomatic ones.

The physis region of pathologic hips showed the highest intensity of color Doppler signals, indicating greater intraosseous vascularity, suggesting that targeted sonographic assessments can improve the evaluation of hip conditions in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Legg-Calvé-Perthes disease: multipositional power Doppler sonography of the proximal femoral vascularity. Doria, AS., Cunha, FG., Modena, M., et al.[2021]

The study demonstrates that 3-dimensional vibroacoustography can effectively assess the uncovered cup area after total hip arthroplasty, providing high-resolution images with a relative error of only 8.1% compared to traditional motion capture methods.

This imaging technique offers a promising new way to evaluate implant fixation post-surgery, which is crucial for determining the success of the procedure and could be applied to other bone or implant imaging scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vibroacoustography for the assessment of total hip arthroplasty. Kamimura, HA., Wang, L., Carneiro, AA., et al.[2022]

Traditional radiography remains a crucial and effective method for diagnosing and managing hip diseases, allowing for the recognition and treatment of lesions in most cases.

While advanced imaging techniques like CT, ultrasound, and MRI provide valuable insights into soft tissues and cartilage, their use should be approached with caution due to limited data and the need for careful interpretation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imaging of the hip]. Métaizeau, J.[2016]

Ultra-low-dose CT (ULD CT) is significantly more sensitive than radiographs for detecting fractures in the spine and pelvic regions, with sensitivities ranging from 80% to 100% compared to 50% to 85% for radiographs.

The effective radiation dose from ULD CT is comparable to that of radiographs, suggesting that ULD CT could be a safer and more effective alternative for diagnosing fractures in minor trauma cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultra-low-dose CT versus radiographs for minor spine and pelvis trauma: a Bayesian analysis of accuracy. Hamard, A., Greffier, J., Bastide, S., et al.[2021]

Sonography is particularly effective for evaluating conditions like congenital dysplasia of the hip, hip effusion, and soft-tissue foreign bodies in children, highlighting its practical applications in pediatric musculoskeletal diseases.

CT and MR imaging play crucial roles in diagnosing more complex conditions such as congenital dysplasia of the hip, osteomyelitis, and musculoskeletal tumors, showcasing their importance in comprehensive musculoskeletal assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diseases of the musculoskeletal system in children: imaging with CT, sonography, and MR. Schlesinger, AE., Hernandez, RJ.[2016]

Conventional radiography remains the primary imaging method for evaluating hip joint arthroplasty, effectively identifying early and late complications such as loosening and infections in most cases.

When radiography is insufficient for diagnosis, advanced imaging techniques like CT and MRI can provide crucial additional information, especially for detecting inflammatory processes, highlighting the importance of combining imaging results with clinical symptoms for accurate diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Imaging of hip joint arthroplasty]. Mayerhoefer, ME., Frühwald-Pallamar, J., Czerny, C.[2021]

Imaging techniques like CT, MRI, and ultrasound are essential for accurately evaluating hip disorders, and orthopedic surgeons must understand how to interpret these images in relation to normal anatomy and pathology.

The article emphasizes the importance of correlating radiographic findings with clinical evaluations to enhance the diagnosis and treatment of musculoskeletal disorders affecting the hip.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of the pelvis and hip. Pitt, MJ., Lund, PJ., Speer, DP.[2016]

The role of radiologists in postoperative care for hip surgeries is crucial, as they must understand hip anatomy, surgical procedures, and expected imaging outcomes to ensure accurate interpretations and interventions.

This article reviews imaging techniques like radiography, ultrasound, CT, and MRI, highlighting their importance in evaluating postoperative complications and normal appearances after various hip surgeries, including chondrolabral repair and hip arthroplasty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative Musculoskeletal Imaging and Interventions Following Hip Preservation Surgery, Deformity Correction, and Hip Arthroplasty. Samim, M., Khodarahmi, I., Burke, C., et al.[2022]

The study presents a new method for estimating hip displacement using ultrasound images, validated through simulations and in vitro studies with 3-D-printed hip phantoms, showing a maximum diameter error of 16.1% under challenging conditions.

In a pilot clinical trial, the ultrasound method demonstrated a mean absolute difference of only 3.5% compared to traditional X-ray measurements, indicating its potential accuracy and effectiveness for evaluating hip displacement in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultrasound Imaging of Hip Displacement in Children With Cerebral Palsy. Pham, TT., Le, LH., La, TG., et al.[2023]

Ultrasound is a safe and accessible imaging technique for evaluating hip pain, as it does not involve radiation and allows for dynamic assessment of both hips.

Despite challenges due to the hip's complex anatomy, ultrasound can effectively guide interventional procedures and assess various hip compartments using appropriate transducer frequencies based on patient body type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-resolution ultrasound in the evaluation of the adult hip. Probyn, L., Flores, D., Rowbotham, E., et al.[2023]

Advanced computed tomographic and computer graphic techniques significantly improve the accuracy of diagnosing hip problems, allowing for better identification of issues.

These techniques also facilitate three-dimensional surgical planning, enabling surgeons to rehearse procedures, evaluate surgical strategies, and create personalized prosthetic designs for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of advanced CT imaging and computer graphics methods to reconstructive surgery of the hip. Robertson, DD., Walker, PS., Fishman, EK., et al.[2022]

Low dose computed tomography (CT) can effectively diagnose hip abnormalities in children while maintaining radiation exposure levels similar to conventional methods.

The use of thick slices and image integration in this CT procedure makes it a preferred choice for routine examinations, enhancing safety without compromising diagnostic quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation exposure and image quality in computed tomography for hip joint measurements in children. Linnebank, F., Witkamp, TD., Scholten, ET.[2016]

The REDUCTION imaging protocol significantly reduced radiation exposure for patients undergoing CT scans for traumatic fractures, with an average dose of 0.15 mSv compared to 1.50 mSv for conventional CT, representing a tenfold decrease.

Despite the reduced radiation dose, the REDUCTION protocol did not compromise clinical outcomes, as there were no significant differences in time to fracture union, complications, or other quality measures compared to conventional CT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ultralow-Dose CT (REDUCTION Protocol) for Extremity Fracture Evaluation Is as Safe and Effective as Conventional CT: An Evaluation of Quality Outcomes. Konda, SR., Goch, AM., Haglin, J., et al.[2019]

A dynamic ultrasound protocol for evaluating hip microinstability was tested on 27 patients, showing substantial interrater reliability (κ 0.606), indicating that different evaluators can consistently diagnose this condition.

This technique enhances traditional static imaging by allowing real-time assessment of hip instability and related conditions during physical examination, improving the overall diagnostic process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dynamic ultrasound assessment of hip instability and anterior and posterior hip impingement. Sahr, ME., Endo, Y., Sink, EL., et al.[2023]

Citations

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The role of ultrasonography in the assessment of peri- ... US is an efficient and practical imaging modality to evaluate peri-prosthetic complications in patients with THA, being almost comparable to MRI.

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Limited Effectiveness of Sonography in Revealing Hip Joint ... The object of this study was to determine the effectiveness of sonography in the detection of hip joint effusions in both native and postoperative adult hips.

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Imaging of the Hip Prior to Replacement: What the Surgeon ... Total hip arthroplasty (THA) is an effective means of treating severe refractory hip pain and functional disability in the setting of degenerative arthritis.

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Sonography after total hip replacement Our study provides clear values for the normal postoperative sonographic image after total hip replacement. Our data can be considered to be rep- resentative ...

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Diagnostic Performance of Ultrasound to Evaluate Mild Hip ... Purpose. To study the diagnostic performance of ultrasound (US) in mild hip osteoarthritis (HOA) compared to conventional radiography (CR) ...

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A comparison of ultrasound and fluoroscopic guidance This study demonstrates that the use of ultrasound guidance for hip joint aspiration, when compared to fluoroscopic guidance, is more likely to result in a ...

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Ultrasound-Guided Intervention Around the Hip Joint | AJR We review some of the most common reasons for ultrasound intervention around the hip joint: intraarticular injection, aspiration of joint fluid.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9369831/

Imaging in Hip Arthroplasty Management Part 2 Hip arthroplasty (HA) is a frequently used procedure with high success rates, but 7% to 27% of the patients complain of persistent postsurgical ...

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Practical office ultrasound for the hip surgeon: current ... Safe injection: the entry point should allow maximal specular reflection of the needle aiming the probe in the long axis (needle parallel to the transducer).

10. aetna.com aetna.com/cpb/medical/data/200_299/0287.html

Hip Arthroplasty - Medical Clinical Policy Bulletins Other factors that were documented include time after surgery (with the greatest risk in the first 30 days) and surgical history (with a greater risk in hips ...