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Uncemented tibial component fixation in total knee replacement using porous titanium. A Randomized RSA Study

Uncemented tibial component fixation in total knee replacement using porous titanium. A Randomized RSA Study - Uncemented tibia fixation in total knee replacement

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON44792
Enrollment
42
Registered
2012-06-28
Start date
2015-06-22
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

cartilage damage Knee arthrosis

Interventions

The patient will receive either the uncemented tibial component with the plasma sprayed coating (control group) or the uncemented porous coated tibial component (intervention group)

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: • Patients diagnosed with osteoarthritis or rheumatoid arthritis of the knee requiring primary total knee arthroplasty • Patients capable of giving Informed Consent and expressing willingness to comply with the post-operative follow-up program • Patients having no major deformities, i.e. sagittal and coronal deformities are less than 15 degrees

Exclusion criteria

Exclusion criteria: • Patients requiring revision arthroplasty • Patients unable or unwilling to sign the Patient Informed Consent specific to this study • Patients with osteoporosis of the tibial plateau • Patients with functional impairment of any other lower extremity joint besides the operated knee • Patients having a flexion contracture of 15° and more • Patients having a varus or valgus contracture of 15° and more • Patients having insufficient understanding of Dutch language to participate • Patients incompetent to fill in the clinical scores

Design outcomes

Primary

MeasureTime frame
Migration parameters: - Maximum total point migration (MTPM) - Maximum subsidence - Maximum lift-off

Secondary

MeasureTime frame
Clinical evaluation: - IKSS (International Knee Society Score)39 - SF36 (Short Form (36) health survey)40 - KOOS (Knee injury and Osteoarthritis Outcome Score)41 - Range of motion of the knee

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)