Patient-Specific Computational Walking Models in Improving Surgical and Rehabilitation Treatment in Patients With Pelvic Sarcomas

  • STATUS
    Recruiting
  • End date
    May 31, 2023
  • participants needed
    130
  • sponsor
    M.D. Anderson Cancer Center
Updated on 30 September 2021

Summary

This trial studies the development of patient-specific computational walking models to improve the surgical planning and rehabilitation treatment of patients with pelvic sarcomas. Every pelvis and pelvic sarcoma are different, and the orthopedic oncologist faces significant challenges when removing a tumor from the complex anatomy of the pelvis. These challenges make it difficult to achieve excellent oncological and functional outcomes together. Computational walking models may be used to predict the best combination of surgical methods and how to implement them to maximize each patient's post-surgery walking function.

Description

PRIMARY OBJECTIVES:

I. To develop patient-specific computational walking models to predict the optimal combination of pelvic sarcoma surgical and rehabilitation decisions that will maximize each patient's post-surgery walking function.

II. To collect experimental movement and imaging data prospectively and retrospectively from individuals who have already received, or are going to receive, a type I or type II hemipelvectomy.

III. To use the data to develop computational modeling and simulation methodologies that can predict an individual patient's post-surgery walking function given pre-surgery movement and imaging data and the surgical decisions made by the surgeon.

OUTLINE

Patients undergo walking function assessment using optical motion capture and bi-plane dynamic X-ray imaging pre- and post-hemipelvectomy.

Details
Condition Pelvic Sarcoma
Treatment X-Ray Imaging, Functional Assessment
Clinical Study IdentifierNCT05054335
SponsorM.D. Anderson Cancer Center
Last Modified on30 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients who have received or are scheduled to receive a type II or any combination of type II (e.g., type I + II, II + III, or I + II + III) hemipelvectomy surgery without reconstruction or with allograft reconstruction at University of Texas (UT) MD Anderson Cancer Center

Exclusion Criteria

Patients whose leg has been or will be amputated by hemipelvectomy surgery
Previous surgery or significant injury to either hip
Relevant surgery, procedure, injury, or condition in the last two years which may affect hip pain or general movement patterns on either side
Diagnosis of osteoarthritis, rheumatoid conditions, cancers, or other conditions which may affect musculoskeletal health
Pregnant women or women nursing an infant
Persons with body mass index (BMI) > 30 and/or waist size > 100 cm (39 in) (these individuals would likely require higher radiation doses than are specified for this study)
Persons with a history of significant radiation exposure (greater than 25 mSv), whether occupational or medical in nature. Anyone with a history of medical radiation therapy (for cancer or other conditions) is excluded from the study
Persons with a pacemaker, hearing aid, aneurysm clips or artificial heart valves, and other forms of loose metal implants will be excluded from the study as assessed by a pre-magnetic resonance imaging (MRI) questionnaire administered by the MRI technician at the time of the scan
Radiological exclusion criteria (assessed after magnetic resonance [MR] scan is conducted on the first visit, prior to dynamic stereo X-ray [DSX]/computed tomography [CT] radiation exposure): evidence on preliminary MRI of avascular necrosis (AVN), fracture, slipped capital femoral epiphysis (SCFE), collapsed joint space or advanced osteoarthritis, hip dysplasia, masses, lesions, or other anomalies not consistent with a femoro-acetabular impingement (FAI) diagnosis
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