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Comparing the migration and inducible displacement through RSA of the cementless ATTUNETM Rotating Platform and the cementless LCS Rotating Platform Knee system; A Clinical Randomized Controlled RSA follow-up study*

Comparing the migration and inducible displacement through RSA of the cementless ATTUNETM Rotating Platform and the cementless LCS Rotating Platform Knee system; A Clinical Randomized Controlled RSA follow-up study* - ALknee Follow-up Study

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51661
Enrollment
52
Registered
2022-11-02
Start date
2022-10-31
Completion date
Unknown
Last updated
2024-04-09

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

Conditions

Total Knee Arthroplasty

Interventions

None listed

Sponsors

Spaarne Gasthuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All patients that participated in the initial study (NL58911.058.16) - Patient that are capable of giving informed consent and expressing a willingness to comply with the study.

Exclusion criteria

Exclusion criteria: - The patient underwent a major revision TKR (exchange of the tibial or femoral component). - The patient is unable or unwilling to sign the informed consent specific to this study.

Design outcomes

Primary

MeasureTime frame
- Migration measured with RSA

Secondary

MeasureTime frame
- Inducible displacement measured with RSA. - Patient-reported satisfaction is measured by questionnaires. - Clinical and radiographic outcomes are measured by physical examination and RSA radiographs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)