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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

Objective measures of skeletal muscle features have previously been used to assess skeletal muscle quality. In certain clinical populations, such as intensive care (ICU) patients, specific features of the psoas muscle measured by abdominal CT have been used to assess the nutritional status of the patient. Abdominal CT is not performed routinely as it exposes the patient to ionizing radiation (X-rays) and can only be performed intermittently. The measurement of the thigh muscles (rectus femoris muscle, part of the quadriceps muscle) by handheld musculoskeletal (MSK) ultrasound is a simple, safe (no ionizing radiation) and repeatable (can be easily performed on a daily basis) technique. A correlation has been shown between muscle parameters of the psoas muscle (abdominal CT) and the rectus femoris muscle (MSK). A direct comparison between muscle parameters of the same skeletal muscle measured with both CT and MSK has not been done. Intramuscular adipose tissue (IMAT) is a measure of the extent of adipose tissue deposited within the muscle. It is a biomarker of muscle quality. The study objective is to compare muscle area and intramuscular adipose tissue (IMAT) content of rectus femoris muscle, measured by standard CT imaging with point of care handheld musculoskeletal (MSK) ultrasound in patients presenting for primary total hip arthroplasty. This patient group is chosen because they will have hip CT performed as standard of care prior to surgery.

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 data supports the effectiveness of this treatment for hip surgery assessment?

Ultrasound is highlighted as a useful tool for evaluating hip issues because it is accessible, does not involve radiation, and can assess both sides of the hip and guide procedures. It is particularly effective in assessing hip pain and instability, and can be adapted for different body types to ensure accurate imaging. ^{1 2 3 4 5}

Is imaging for hip surgery assessment safe?

CT scans, including low-dose and ultra-low-dose versions, are generally considered safe for hip imaging, with radiation exposure similar to conventional methods. Ultrasound imaging is also used safely for assessing hip displacement, especially in children. ^{6 7 8 9 10}

How does the imaging treatment for hip surgery assessment differ from other treatments?

The imaging treatment using CT and ultrasound for hip surgery assessment is unique because it provides detailed three-dimensional views and visualizes soft tissues and cartilage, which helps in diagnosing hip conditions, planning surgeries, and evaluating postoperative results. This approach is more advanced compared to traditional X-rays, which primarily show bone structures. ^{11 12 13 14 15}

Research Team

David MacLeod

Principal Investigator

Duke University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

High-resolution ultrasound in the evaluation of the adult hip. [2023]

2. Ireland pubmed.ncbi.nlm.nih.gov

Clinical value of digital tomographic fusion imaging in the diagnosis of avascular necrosis of the femoral head in adults. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Legg-Calvé-Perthes disease: multipositional power Doppler sonography of the proximal femoral vascularity. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Vibroacoustography for the assessment of total hip arthroplasty. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Dynamic ultrasound assessment of hip instability and anterior and posterior hip impingement. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Postoperative Musculoskeletal Imaging and Interventions Following Hip Preservation Surgery, Deformity Correction, and Hip Arthroplasty. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Ultrasound Imaging of Hip Displacement in Children With Cerebral Palsy. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Ultra-low-dose CT versus radiographs for minor spine and pelvis trauma: a Bayesian analysis of accuracy. [2021]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Radiation exposure and image quality in computed tomography for hip joint measurements in children. [2016]

10. United States 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. [2019]

11. France pubmed.ncbi.nlm.nih.gov

[Imaging of the hip]. [2016]

12. United States pubmed.ncbi.nlm.nih.gov

Imaging of the pelvis and hip. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

The application of advanced CT imaging and computer graphics methods to reconstructive surgery of the hip. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

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

15. Germany pubmed.ncbi.nlm.nih.gov

[Imaging of hip joint arthroplasty]. [2021]