Twente Lower Extremity Model safe: Improving safety and predictability of complex musculo-skeletal surgery using a patient-specific navigation system.

Twente Lower Extremity Model safe: Improving safety and predictability of complex musculo-skeletal surgery using a patient-specific navigation system. - TLEMsafe

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON36523

Enrollment

Registered

2011-07-26

Start date

2011-07-28

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

None not in this application: hip dysplasia osteosarcoma) this research involves healthy subjects. (at a later stage

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy, age 18-60, body mass index 17-30.

Exclusion criteria

Exclusion criteria: Deformities of the musculo-skeletal system such as scoliosis and hip dysplasia. Use of medication that affects the functioning or the neurological control of the musculo-skeletal system. Having had major injury or orthopedic surgery of the lower extremity at any time during life. History of ailment related to carbohydrate metabolism, or to cardiac or muscular disease. Being pregnant or having the intention to become pregnant during the course of the study.

Design outcomes

Primary

Measure	Time frame
Our primary outcomes are anatomical and physiological musculo-skeletal parameters. The anatomical parameters are extracted from MRI scans. They consist of muscle attachment points, muscle wrapping contours, muscle volumes, bony landmarks, tendon lengths and physiological cross-sectional areas of muscles. Physiological parameters are measured from kinematic and ground reaction force data, surface electromyography, oxygen measurements, and PET during various activities. They consist of torque around the hips, knees and ankle joints, joint compression forces, muscle activition timing, muscle force production and muscle energy consumption. The latter two are particularly important to validate because they are primary outcomes of the M-S models. Muscle energy consumption will be measured with PET.	—

Measure

Time frame

Our primary outcomes are anatomical and physiological musculo-skeletal parameters. The anatomical parameters are extracted from MRI scans. They consist of muscle attachment points, muscle wrapping contours, muscle volumes, bony landmarks, tendon lengths and physiological cross-sectional areas of muscles. Physiological parameters are measured from kinematic and ground reaction force data, surface electromyography, oxygen measurements, and PET during various activities. They consist of torque around the hips, knees and ankle joints, joint compression forces, muscle activition timing, muscle force production and muscle energy consumption. The latter two are particularly important to validate because they are primary outcomes of the M-S models. Muscle energy consumption will be measured with PET.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

Netherlands

Outcome results