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.
Completed
- Conditions
- (specific type of) cancer.Sarcoma10028389
- Registration Number
- NL-OMON37531
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
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
- 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.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameters are 1) changes in anatomical musculo-skeletal<br /><br>parameters pre- and post-OR, and 2) the amount of difference in spatiotemporal,<br /><br>kinematic and kinetic parameters during basic activities of daily living<br /><br>between model outcome and actual measurement (9 months post-OR). The anatomical<br /><br>parameters consist of muscle attachment points, muscle wrapping contours,<br /><br>muscle volumes, bony landmarks, tendon lengths and physiological<br /><br>cross-sectional areas of muscles. The spatiotemporal, kinematic and kinetic<br /><br>parameters include walking speed, stride length, cadence, hip range of motion,<br /><br>maximal hip flexion/extension, hip power generation/absorption, and hip flexion<br /><br>moment during various activities of daily living. </p><br>
- Secondary Outcome Measures
Name Time Method <p>not applicable.</p><br>