EOS X-Ray Imaging for Hip Reconstruction Planning in Osteoarthritis

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Lumbosacral hardware, contralateral THA

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to better understand how different X-ray views can aid in planning hip reconstruction surgery for people with osteoarthritis. It will use a special kind of X-ray called EOS, known for providing clear images with less radiation. The study includes two groups: one will receive the EOS X-ray before hip surgery, and the other will receive it after surgery. Ideal participants are those about to undergo or who have recently undergone hip reconstruction and do not have metal implants in their lower back. As an unphased trial, this study offers participants the chance to contribute to research that could enhance surgical planning and outcomes for future patients.

Do I need to stop my current medications for this trial?

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

What prior data suggests that EOS X-Ray imaging is safe for hip reconstruction planning?

Research has shown that the EOS X-Ray imaging system is safe for people. Studies have found that EOS imaging provides clear pictures with significantly less radiation than traditional methods like CT scans. This reduces harm while still supplying doctors with essential information.

Doctors often use EOS exams to plan and monitor treatment for hip and other bone issues. The system captures images quickly, usually in less than 20 seconds, minimizing radiation exposure.

Overall, the EOS X-Ray imaging system is well-tolerated and widely used for treating hip and other bone-related conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the EOS X-Ray imaging technique for hip reconstruction planning in osteoarthritis because it offers a 3D perspective with lower radiation exposure compared to traditional X-rays and CT scans. Unlike standard imaging methods that provide 2D images, EOS X-Ray captures detailed 3D images while the patient is standing, which can offer a more accurate representation of the hip joint's alignment and weight-bearing condition. This advanced imaging approach could potentially lead to better surgical planning and outcomes for patients undergoing total hip arthroplasty (THA).

What evidence suggests that EOS X-Ray is effective for hip reconstruction planning in osteoarthritis?

Research has shown that the EOS X-ray system effectively measures hip joints. One study found its accuracy comparable to CT scans, which are more detailed but involve higher radiation levels. Thus, EOS X-ray provides clear images with reduced radiation exposure. In this trial, participants will receive EOS imaging either before or after Total Hip Arthroplasty (THA). The system is particularly useful for planning hip surgeries, such as hip replacements, as it helps doctors assess leg length and alignment, crucial for successful surgery. This makes EOS X-ray a valuable tool for treating hip osteoarthritis, which involves joint inflammation. ^{1 3 6 7 8}

Who Is on the Research Team?

Matthew Abdel, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for individuals who are planning to have or have already had hip reconstruction surgery (THA) and can give informed consent. It includes 40 patients divided into groups based on their age and sex: at least 20 must be over 70 years old, with the rest spread across younger age ranges, and an equal number of men and women. People with a hip replacement on the opposite side or those with hardware in their lower back cannot participate.

Inclusion Criteria

Ability to provide informed consent

I am one of 40 patients, either before or after hip replacement surgery.

I am within one of the specified age groups for the study.

Exclusion Criteria

Patients with contralateral THA

Patients with lumbosacral hardware

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-THA Imaging

Subjects will be receiving EOS imaging prior to Total Hip Arthroplasty (THA)

Baseline

1 visit (in-person)

Post-THA Imaging

Subjects will be receiving EOS imaging after Total Hip Arthroplasty (THA)

8 hours to 4 weeks

2 visits (in-person)

Follow-up

Participants are monitored for changes in spinopelvic parameters after surgery

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• EOS X-Ray

Trial Overview The study is examining how consistent measurements from different X-ray views (EOS X-Ray) are for patients before and after hip reconstruction surgery. The goal is to see if these imaging techniques correlate well enough to be reliable for assessing changes due to surgery.

How Is the Trial Designed?

Group I: Pre-THA Experimental Treatment 1 Intervention

Subjects will be receiving EOS imaging prior to Total Hip Arthroplasty (THA)

Group II: Post-THA Experimental Treatment 1 Intervention

Subjects will be receiving EOS imaging after Total Hip Arthroplasty (THA)

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10661804/

“The accuracy of the EOS imaging system to assess hip ... This includes a summary of the study characteristics and outcomes related to the precision of the EOS imaging system compared to CT scans in the ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12224773/

Osteoarthritis Year in Review 2022: Imaging - PMC This narrative review summarizes original research focusing on imaging in osteoarthritis (OA) published between April 1st 2021 and March 31st 2022.

3. eos-imaging.com eos-imaging.com/us/publications

Publications Accuracy and reproducibility of preoperative three-dimensional planning for total hip arthroplasty using biplanar low-dose radiographs : A pilot study.

4. mdpi.com mdpi.com/2813-8759/2/1/7

Clinical Application of the EOS Imaging System ... Key clinical applications of EOS imaging include lower extremity analysis, eg, leg length assessment and knee/hip arthroplasty planning, pelvic and spinal ...

5. withpower.com withpower.com/trial/phase-osteoarthritis-hip-1-2022-ec33e

EOS X-Ray Imaging for Hip Reconstruction Planning in ... This research is being conducted to assess measurement correlations on different X-ray views on patients who have undergone or will undergo hip reconstruction ...

6. eos-imaging.com eos-imaging.com/us/for-patients

For Patients EOS exams are used to diagnose, plan treatment and monitor various skeletal conditions, including those affecting your spine, hip, knees, and lower limbs. Spine.

7. uhhospitals.org uhhospitals.org/services/radiology-services/radiology-procedures/eos-imaging

Low Dose Imaging - EOS |Radiology Services EOS imaging captures 1:1 functional 2D/3D images in under 20 seconds to support well-informed diagnoses, highly precise presurgical planning and postsurgical ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0268003314002939

Healthy vs. osteoarthritic hips: A comparison of hip, pelvis ... The EOS® system addresses the limitations of CT and MRI by providing whole-body imaging, in weight-bearing, with low dose, with an acquisition time less than 20 ...