Recruiting

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT05054335

Conditions

Pelvic Sarcoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Functional Assessment

X-Ray Imaging

Study Details

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

Study ID

NCT05054335

Start date

Jun 20, 2019

Status verified date

May, 2026

Completion date

Dec 21, 2027

Anticipated

Primary completion date

Dec 21, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
6. Radiological exclusion criteria (assessed after MR scan is conducted on the first visit, prior to DSX/CT radiation exposure): evidence on preliminary MRI of fracture, slipped capital femoral epiphysis (SCFE), masses, lesions, or other anomalies not consistent with an FAI diagnosis.

Study Design

Enrollment

130 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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

Interventions

Functional Assessment

Undergo walking function assessment with optical motion capture

X-Ray Imaging

Undergo bi-plane dynamic X-ray imaging

Primary outcome measure

  • To establish the patient-specific computational models to inform surgical decisions and design custom implants that maximize post-surgery function. [ Time Frame: through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Valerae O Lewis, BS,MD

(713) 792-5073volewis@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Valerae O. Lewis

713-745-4117volewis@mdanderson.org

Principal Investigator:

Valerae O. Lewis

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

May 20, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-05-20.