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

NCT ID: NCT05054335

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-20
• Study Completion Date: 2027-12-21

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.

Detailed 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.

Conditions

Pelvic Sarcoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive care (walking function test, X-ray)

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

Group Type: EXPERIMENTAL

Functional Assessment

Intervention Type: OTHER

Undergo walking function assessment with optical motion capture

X-Ray Imaging

Intervention Type: PROCEDURE

Undergo bi-plane dynamic X-ray imaging

Retrospective Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Functional Assessment

Undergo walking function assessment with optical motion capture

Intervention Type: OTHER

X-Ray Imaging

Undergo bi-plane dynamic X-ray imaging

Intervention Type: PROCEDURE

Other Intervention Names

Conventional X-Ray; Diagnostic Radiology; Medical Imaging, X-Ray; Radiography; Static X-Ray; X-Ray

Eligibility Criteria

Inclusion Criteria

1. Patients who have received or are scheduled to receive an internal hemipelvectomy with or without reconstruction at UT MD Anderson Cancer Center.

2. Patients who are 18 years of age and older

Exclusion Criteria

1. Patients who have undergone an external (hindquarter amputated), or an isolated type III internal hemipelvectomy.

2. Previous surgery or significant injury to either hip (prospective patients only)

3. 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)

4. Pregnant women or women nursing an infant

5. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Valerae O Lewis

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

M D Anderson Cancer Center

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Valerae O Lewis, BS,MD

Role: CONTACT

volewis@mdanderson.org

(713) 792-5073

Facility Contacts

Valerae O. Lewis

Role: primary

volewis@mdanderson.org

713-745-4117

Related Links

http://www.mdanderson.org

M D Anderson Cancer Center

Other Identifiers

NCI-2019-00862

Identifier Type: REGISTRY

Identifier Source: secondary_id

2018-0216

Identifier Type: OTHER

Identifier Source: secondary_id

2018-0216

Identifier Type: -

Identifier Source: org_study_id