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.

Completed

• Conditions: 1) Congenital hip dysplasia; and 2) hip revision.; dislocation of the hip; 10023213

• Registration Number: NL-OMON37914
• Lead Sponsor: niversitair Medisch Centrum Sint Radboud

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 15

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

- 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.

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 ADL between model outcome and<br /><br>actual measurement (6-9 months post-OR). The anatomical parameters consist of<br /><br>the hip centre of rotation, femoral shortening length, muscle attachment<br /><br>points, muscle wrapping contours, muscle volumes, bony landmarks, tendon<br /><br>lengths and physiological cross-sectional areas of muscles. The spatiotemporal,<br /><br>kinematic and kinetic parameters include walking speed, stride length, cadence,<br /><br>hip range of motion, maximal hip flexion/extension, hip power<br /><br>generation/absorption, and hip flexion moment during various ADL. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable.</p><br>