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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON37914

Enrollment

Registered

2012-06-15

Start date

2013-02-01

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

1) Congenital hip dysplasia and 2) hip revision. dislocation of the hip

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients must have developmental dysplasia of the hips or require a major revision of a previously implanted total hip replacement, be between 18-70 years of age, and have a body mass index between 17-30.

Exclusion criteria

Exclusion criteria: - Substantial neurologic or musculo-skeletal disorders that would adversely affect ability to perform ADL; - Use of medication that affects the functioning or the neurological control of the M-S system; - Prior intraarticular infection of the hip; - Osteoporosis.

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 ADL between model outcome and actual measurement (6-9 months post-OR). The anatomical parameters consist of the hip centre of rotation, femoral shortening length, 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 ADL.	—

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 ADL between model outcome and actual measurement (6-9 months post-OR). The anatomical parameters consist of the hip centre of rotation, femoral shortening length, 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 ADL.

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Secondary

Measure	Time frame
not applicable.	—

Countries

Netherlands

Outcome results