Migration and kinematics of the new Persona PS versus the proven NexGen LPS knee - a randomized controlled trial using radiostereometric analysis, fluoroscopy and gait
Phase 4
Completed
- Conditions
- Artificial Knee JointTotal Knee Artroplasty1002321310005944
- Registration Number
- NL-OMON50724
- Lead Sponsor
- Orthopaedie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>* Migration, measured by means of RSA. </p><br>
- Secondary Outcome Measures
Name Time Method <p>* Prosthesis placement and bone resection measured by means of CT and caliper<br /><br>measurements of the resected bone parts.<br /><br>* In vivo kinematics by means of fluoroscopy and gait analysis.<br /><br>* Patient Reported Outcome Measures by means of questionaires. </p><br>