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A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM

A CLINICAL RANDOMIZED CONTROLLED RSA TRIAL COMPARING THE CEMENTLESS ATTUNE ROTATING PLATFORM KNEE SYSTEM TO THE CEMENTLESS LCS ROTATING PLATFORM KNEE SYSTEM - RSA RCT: ATTUNE RP TKA versus LCS RP TKA

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50362
Enrollment
60
Registered
2017-03-14
Start date
2017-07-31
Completion date
Unknown
Last updated
2024-04-23

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 Arthroplasty

Sponsors

Spaarne Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age: 21- 90 years Indications: Patient is diagnosed with osteoarthritis 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

Exclusion criteria

Exclusion criteria: The patient has an a-priori risk for a posterior-stabilized total knee arthroplasty. - Status after patellectomy - In case flexion is less than 90 degrees 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 Patient is diagnosed with rheumatoid arthritis 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

Design outcomes

Primary

MeasureTime frame
The primary objective of this study is to compare the magnitude and pattern of migration of the prostheses (Femoral and Tibial component) during the first and second post-operative year.

Secondary

MeasureTime frame
The secondary objective of this study is to compare clinical and radiological outcome of the prostheses and PROMS and to compare clinical and radiological outcome and PROMS of the prostheses with migration data.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)