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

NCT05054335 | Recruiting

• 2 other identifiers: 2018-0216NCI-2019-00862
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Sarcoma

Outcome Measures

Primary Outcomes (1)

• To establish the patient-specific computational models to inform surgical decisions and design custom implants that maximize post-surgery function.

  through study completion, an average of 1 year

Study Arms (2)

Supportive care (walking function test, X-ray)

EXPERIMENTAL

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

Other: Functional Assessment; Procedure: X-Ray Imaging

Retrospective Group

NO INTERVENTION

1. Acquisition of pre- and post-operative MRI data of the pelvic region (when available) collected previously as part of standard clinical care 2. Acquisition of pre-operative CT data of the pelvic region (when available) collected previously as part of standard clinical care 3. Acquisition of Physical Therapy Assessment data collected previously by a physical therapist and/or physical therapist assistant under protocol PA12-1046

Interventions

Functional Assessment OTHER

Undergo walking function assessment with optical motion capture

Supportive care (walking function test, X-ray)

X-Ray Imaging PROCEDURE

Undergo bi-plane dynamic X-ray imaging

Also known as: Conventional X-Ray, Diagnostic Radiology, Medical Imaging, X-Ray, Radiography, Static X-Ray, X-Ray

Supportive care (walking function test, X-ray)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who have received or are scheduled to receive an internal hemipelvectomy with or without reconstruction at UT MD Anderson Cancer Center.
• Patients who are 18 years of age and older

You may not qualify if:

• Patients who have undergone an external (hindquarter amputated), or an isolated type III internal hemipelvectomy.
• Previous surgery or significant injury to either hip (prospective patients only)
• Relevant surgery, procedure, injury, or condition in the last two years which may affect hip pain or general movement patterns on either side (prospective patients only)
• Pregnant women or women nursing an infant
• 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-MRI questionnaire administered by the MRI technician at the time of the scan.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Valerae O Lewis

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valerae O Lewis, BS,MD

CONTACT

(713) 792-5073; volewis@mdanderson.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: September 23, 2021
• Study Start: June 20, 2019
• Primary Completion (Estimated): December 21, 2027
• Study Completion (Estimated): December 21, 2027
• Last Updated: November 18, 2025

Record last verified: 2025-11

Locations

US (1)