Functional Assessment + X-Ray Imaging for Pelvic Sarcoma

Overseen By Valerae O Lewis, BS,MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: External hemipelvectomy, Hip surgery, Pregnancy, Pacemaker, others

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

Compensation: Varies

Number of Visits: 2

130 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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

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

What data supports the effectiveness of the treatment Functional Assessment + X-Ray Imaging for Pelvic Sarcoma?

Research suggests that maintaining or strengthening the psoas muscle (a muscle in the lower back) after surgery can improve walking function in patients with pelvic sarcoma. Additionally, using accelerometers to track physical activity has shown promise in evaluating patient recovery and treatment effectiveness. ^{1 2 3 4 5}

Is the Functional Assessment and X-Ray Imaging for Pelvic Sarcoma safe for humans?

The research does not provide specific safety data for Functional Assessment and X-Ray Imaging in humans, but it discusses the potential benefits of using personalized models to improve surgical outcomes and rehabilitation for pelvic sarcoma patients. ^{3 4 5 6 7}

How does the treatment in the trial differ from other treatments for pelvic sarcoma?

The treatment in the trial combines functional assessment and X-ray imaging, which may offer a unique approach by focusing on the recovery of muscle function and bone structure after surgery. This is different from other treatments that may not emphasize the detailed monitoring of muscle recovery and bone deformation, potentially leading to better personalized rehabilitation strategies. ^{3 8 9 10 11}

Research Team

Valerae O. Lewis

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for adults who have or will undergo internal hemipelvectomy at UT MD Anderson Cancer Center to treat pelvic sarcomas. It's not for those with certain hip conditions, previous significant hip injuries/surgeries, recent surgeries affecting movement, pregnant/nursing women, or individuals with specific metal implants.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for or have had a surgery to remove part of my pelvis at UT MD Anderson.

Exclusion Criteria

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

I have had surgery or a major injury to my hip.

Pregnant women or women nursing an infant

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Surgery Assessment

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

1-2 weeks

1 visit (in-person)

Surgery and Immediate Post-Surgery

Patients receive hemipelvectomy surgery and immediate post-surgery care

1 week

Post-Surgery Assessment

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

1-2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Functional Assessment
• Patient-Specific Computational Walking Models
• X-Ray Imaging

Trial Overview The study is developing personalized computational models to improve surgical planning and rehabilitation for better walking function after surgery in patients with pelvic sarcomas. It involves functional assessments and X-ray imaging to tailor treatment approaches.

Participant Groups

Group I: Supportive care (walking function test, X-ray) Experimental Treatment 2 Interventions

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

Group II: Retrospective Group Active Control 1 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

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

A systematic review of 18 studies found that surgery for lower extremity sarcoma significantly impacts balance, gait, and physical activity outcomes, but existing measures lack the ability to accurately differentiate between clinical groups like limb-sparing surgery and amputation.

There is a critical need for the development of consistent, valid, and reliable objective measures to assess physical functioning in patients post-surgery for lower extremity sarcoma, as current studies show limitations in reliability and sensitivity to change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. Furtado, S., Errington, L., Godfrey, A., et al.[2022]

The StepWatch Activity Monitor (SAM) was validated as an effective tool for objectively measuring walking performance in 29 adult patients with lower extremity sarcoma, showing a moderate positive correlation (r = 0.56) with the Toronto Extremity Salvage Score (TESS).

Patients with osseous tumors walked significantly less (average 1882 steps) compared to those with soft tissue sarcoma (average 3715 steps), highlighting differences in physical activity levels based on tumor type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of objective ambulation in lower extremity sarcoma patients with a continuous activity monitor: rationale and validation. Gundle, KR., Punt, SE., Conrad Iii, EU.[2020]

Custom prosthesis reconstruction after internal hemipelvectomy can significantly impact post-surgery walking function, and retaining or strengthening the psoas muscle is crucial for maximizing this function, as shown by simulations using a personalized neuromusculoskeletal model.

The study found that maintaining or increasing psoas muscle strength led to better walking outcomes, suggesting that surgical decisions regarding the psoas muscle should be carefully considered to improve the durability of custom prostheses and enhance recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computational evaluation of psoas muscle influence on walking function following internal hemipelvectomy with reconstruction. Vega, MM., Li, G., Shourijeh, MS., et al.[2023]

Functional assessments in osteosarcoma patients can provide valuable insights that may improve treatment strategies, utilizing validated patient-reported outcomes and health state utility measures.

Emerging technologies like accelerometers show promise for real-world evaluation of patient activity, potentially correlating with traditional cancer treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the Functional Assessment of Patients with Sarcoma. Ramsey, DC., Gundle, KR.[2021]

Limb salvage procedures for osteosarcoma patients lead to altered gait patterns, with significant reductions in knee flexion during loading compared to both unaffected limbs and healthy controls, indicating potential functional limitations post-surgery.

Muscular integrity, including strength and range of motion, was identified as the key predictor of functional outcomes after limb salvage surgery, while patients using the Stanmore SIMLES prostheses showed better ankle performance than those with the Stryker HMRS prostheses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of kinematic and kinetic patterns following limb salvage procedures for bone sarcoma. Carty, CP., Bennett, MB., Dickinson, IC., et al.[2013]

The study demonstrated that using a thigh-worn accelerometer (AX3) to assess ambulatory activity in 34 patients after sarcoma surgery is feasible and well-tolerated, providing valuable data on their walking patterns and activity levels at home.

Although the AX3 did not distinguish between different tumor sub-groups, it revealed that the pattern of walking (alpha) negatively correlated with disability, suggesting that monitoring walking patterns can help tailor rehabilitation efforts for better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Free-living monitoring of ambulatory activity after treatments for lower extremity musculoskeletal cancers using an accelerometer-based wearable - a new paradigm to outcome assessment in musculoskeletal oncology? Furtado, S., Godfrey, A., Del Din, S., et al.[2023]

This study compared two musculoskeletal models (Human Body Model and OpenSim gait2392) using data from 7 healthy adults, revealing significant differences in joint kinematics, kinetics, and muscle forces, which can impact biomechanical gait analysis outcomes.

The differences in results were attributed to variations in joint center locations and pelvic reference frames, suggesting that while clinical interpretations may remain valid, mechanical analyses requiring precise estimates of movement and loading could be affected by the choice of model.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OpenSim Versus Human Body Model: A Comparison Study for the Lower Limbs During Gait. Falisse, A., Van Rossom, S., Gijsbers, J., et al.[2023]

In a study of 12 pelvic sarcoma patients who underwent internal hemipelvectomy without pelvic reconstruction, an increase in psoas muscle size after surgery was significantly associated with improvements in gait speed, suggesting that muscle recovery plays a crucial role in functional rehabilitation.

The study also found that limb-length discrepancy (LLD) negatively impacted ambulatory function, indicating that minimizing LLD and focusing on psoas muscle strengthening could lead to better clinical outcomes post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in psoas muscle size and ambulatory function after internal hemipelvectomy without reconstruction. Dunbar, NJ., Zhu, YM., Madewell, JE., et al.[2023]

A new method combining a material testing machine with a 3D video motion capturing system successfully measures the dynamic 3D deformation of pelvic bones, achieving a measurement accuracy of ± 0.036 mm, which is crucial for designing better orthopedic implants.

This innovative setup allows for more realistic datasets that can improve the understanding of material characteristics in anatomical specimens, leading to enhanced biomechanical modeling and potentially more effective implant designs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3D video-based deformation measurement of the pelvis bone under dynamic cyclic loading. Göpfert, B., Krol, Z., Freslier, M., et al.[2021]

In a study of 5 patients who underwent surgery for pelvic chondrosarcoma, all patients reported no pain and demonstrated good functional outcomes in work and gait, indicating effective recovery post-surgery.

The study found a significant relationship between hip extension strength and various functional measures, such as gait velocity and weight bearing, suggesting that strengthening hip muscles is crucial for improving mobility after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A follow-up examination of the function of the lower extremity after pelvic tumour extirpation including the acetabular ring. Olsson, E.[2008]

A study involving seven patients who underwent various types of pelvic tumor resections showed that using a hip stabilizer significantly improved their walking speed and other gait parameters, indicating better control over the affected limb.

The findings suggest that a biomechanical approach, such as using a hip stabilizer, can enhance post-operative mobility and gait function in patients after pelvic tumor surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of an external hip joint stabiliser on gait function after surgery for tumours located around the circumference of the pelvis: analysis of seven cases of internal hemipelvectomy or proximal femur resection. Akiyama, T., Saita, K., Ogura, K., et al.[2018]

References

1. England pubmed.ncbi.nlm.nih.gov

Objective clinical measurement of physical functioning after treatment for lower extremity sarcoma - A systematic review. [2022]

2. Egypt pubmed.ncbi.nlm.nih.gov

Assessment of objective ambulation in lower extremity sarcoma patients with a continuous activity monitor: rationale and validation. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Computational evaluation of psoas muscle influence on walking function following internal hemipelvectomy with reconstruction. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Advances in the Functional Assessment of Patients with Sarcoma. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Assessment of kinematic and kinetic patterns following limb salvage procedures for bone sarcoma. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Free-living monitoring of ambulatory activity after treatments for lower extremity musculoskeletal cancers using an accelerometer-based wearable - a new paradigm to outcome assessment in musculoskeletal oncology? [2023]

7. United States pubmed.ncbi.nlm.nih.gov

OpenSim Versus Human Body Model: A Comparison Study for the Lower Limbs During Gait. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Changes in psoas muscle size and ambulatory function after internal hemipelvectomy without reconstruction. [2023]

9. England pubmed.ncbi.nlm.nih.gov

3D video-based deformation measurement of the pelvis bone under dynamic cyclic loading. [2021]

10. Sweden pubmed.ncbi.nlm.nih.gov

A follow-up examination of the function of the lower extremity after pelvic tumour extirpation including the acetabular ring. [2008]

11. Germany pubmed.ncbi.nlm.nih.gov

The effect of an external hip joint stabiliser on gait function after surgery for tumours located around the circumference of the pelvis: analysis of seven cases of internal hemipelvectomy or proximal femur resection. [2018]