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Fluoroscopic and RSA evaluation of the ROCC total knee prosthesis

Fluoroscopic and RSA evaluation of the ROCC total knee prosthesis - ROCC

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON30476
Enrollment
20
Registered
2007-08-08
Start date
2007-04-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

artificial knee Total Knee arthroplasty

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients: •Patient is diagnosed with osteoarthritis and requiring primary arthroplasty •Patient is capable of giving informed consent and expressing a willingness to comply with this study •Patient has no major deformities •The ability to perform a lunge and step-up motion without the help of bars or a cane. •No or slight pain during activity according to the Knee Society Pain Score (Ewald, 1989; Insall et al., 1989);Control group: •The subject has no functional impairment of a lower extremity joint •Subject is capable of giving informed consent and expressing a willingness to comply with this study

Exclusion criteria

Exclusion criteria: Patients: •The patient is unable or unwilling to sign the Informed Consent specific to this study •The individual has a functional impairment of any other lower extremity joint besides the operated knee •Patient has a flexion contracture of more than 15° •Patient has a varus/valgus contracture of more than 15° •Patients requiring revision arthroplasty •The patient does not understand the Dutch or English language good enough to participate. •The use of walking aids •The inability to walk more than 500 meters;Control group: •The subject has a functional impairment of a lower extremity joint •The subject is unable or unwilling to sign the Informed Consent specific to this study •The subject does not understand the Dutch or English language good enough to participate

Design outcomes

Primary

MeasureTime frame
kinematic patterns: segment angles Rotating bearing: degrees micromotion of the prosthesis: mm

Secondary

MeasureTime frame
Compare the kinematic patterns found by fluoroscopy and external movement registration: segment angels EMG: Co-contraction Kinetica

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)