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Migration and kinematics of the new Persona PS versus the proven NexGen LPS knee - a randomized controlled trial using radiostereometric analysis, fluoroscopy and gait

Migration and kinematics of the new Persona PS versus the proven NexGen LPS knee - a randomized controlled trial using radiostereometric analysis, fluoroscopy and gait - Persona versus NexGen

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50724
Enrollment
60
Registered
2014-06-02
Start date
2014-07-10
Completion date
Unknown
Last updated
2025-09-01

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 Artroplasty

Interventions

Total Knee Replacement Surgery

Sponsors

Orthopaedie
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: Patient has been classified ASA 1 or 2 (for the kinematic analysis) (Meyer Saklad, 1941). As for the RSA study all consecutive patients (*usual care*) are included to prevent selection bias in the migration analysis. Stratification is performed per diagnosis group (OA/RA). , Consent: Patient is capable of giving informed consent and expressing a willingness to comply with this study

Exclusion criteria

Exclusion criteria: The patient is unable or unwilling to sign the Informed Consent specific to this study , Insufficient Dutch or English language skills , Patients indicated for revision arthroplasty

Design outcomes

Primary

MeasureTime frame
* Migration, measured by means of RSA.

Secondary

MeasureTime frame
* Prosthesis placement and bone resection measured by means of CT and caliper measurements of the resected bone parts. * In vivo kinematics by means of fluoroscopy and gait analysis. * Patient Reported Outcome Measures by means of questionaires.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)