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A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE (S+Tibia tray) Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System

A Clinical Randomized Controlled RSA Trial Comparing the Cemented ATTUNE (S+Tibia tray) Fixed Bearing Cruciate Retaining Knee System with the Cemented PFC Sigma Fixed Bearing Cruciate Retaining Knee System - RSA RCT: ATTUNE S+ TKA versus Sigma TKA

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52817
Enrollment
70
Registered
2019-02-15
Start date
2019-11-01
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Artificial Knee Joint Total Knee Arthroplasty

Interventions

Total Knee replacement Surgery

Sponsors

Haaglanden Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis or rheumatoid arthritis and requiring primary knee arthroplasty General: All consecutive patients (*usual care*) are included to prevent selection bias in the migration analysis. Consent: Patient is capable of giving informed consent and expressing a willingness to comply with this study

Exclusion criteria

Exclusion criteria: The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty. Insufficiency of the posterior cruciate ligament (PCL) Status after patellectomy In case flexion is less than 90 degrees When it is expected that the tibia cut during surgery will compromise the attachment of the PCL (because of bony defects) The patient is unable or unwilling to sign the Informed Consent specific to this study The patient does not understand the Dutch or English language good enough to participate Patients indicated for revision arthroplasty When there are not enough markers visible in the baseline RSA photograph and it will not improve by placing the patient in another position, the patient will be excluded from the study (secondary exclusion criteria).

Design outcomes

Primary

MeasureTime frame
Migration, measured by means of RSA.

Secondary

MeasureTime frame
Patient Reported Outcome Measures by means of questionaires. (PROMS)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)