TLEMsafe: Improving safety and predictability of complex musculo-skeletal surgery using a patient-specific navigation system. Part IIa: validation with sarcoma patients pre and post OR.

TLEMsafe: Improving safety and predictability of complex musculo-skeletal surgery using a patient-specific navigation system. Part IIa: validation with sarcoma patients pre and post OR. - TLEMsafe part IIa: sarcoma patients.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37531

Enrollment

Registered

2012-05-03

Start date

2013-02-28

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(specific type of) cancer. Sarcoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must have a soft-tissue, Ewing or osteosarcoma in the upper leg or pelvis region, be between 18-60 years of age, and have a body mass index between 17-30.

Exclusion criteria

Exclusion criteria: - Other pre-existing deformities of the M-S system such as scoliosis and hip dysplasia. - Neurological diseases that affect the functioning of the M-S system. - Use of medication that affects the functioning or the neurological control of the M-S system. - Having had major injury or orthopedic surgery of the lower limb at an earlier time in life, from which full recovery was never reached.

Design outcomes

Primary

Measure	Time frame
The main study parameters are 1) changes in anatomical musculo-skeletal parameters pre- and post-OR, and 2) the amount of difference in spatiotemporal, kinematic and kinetic parameters during basic activities of daily living between model outcome and actual measurement (9 months post-OR). The anatomical parameters consist of muscle attachment points, muscle wrapping contours, muscle volumes, bony landmarks, tendon lengths and physiological cross-sectional areas of muscles. The spatiotemporal, kinematic and kinetic parameters include walking speed, stride length, cadence, hip range of motion, maximal hip flexion/extension, hip power generation/absorption, and hip flexion moment during various activities of daily living.	—

Measure

Time frame

The main study parameters are 1) changes in anatomical musculo-skeletal parameters pre- and post-OR, and 2) the amount of difference in spatiotemporal, kinematic and kinetic parameters during basic activities of daily living between model outcome and actual measurement (9 months post-OR). The anatomical parameters consist of muscle attachment points, muscle wrapping contours, muscle volumes, bony landmarks, tendon lengths and physiological cross-sectional areas of muscles. The spatiotemporal, kinematic and kinetic parameters include walking speed, stride length, cadence, hip range of motion, maximal hip flexion/extension, hip power generation/absorption, and hip flexion moment during various activities of daily living.

—

Secondary

Measure	Time frame
not applicable.	—

Countries

Netherlands

Outcome results