Inducible Displacement in Total Knee Prostheses
- Conditions
- reumatoid arthritis for which TKA is performedosteoarthritis
- Registration Number
- NL-OMON21288
- Lead Sponsor
- MC is the sponsor of the study
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
Patients will be included if
• they underwent TKR for primary as well as secondary gonarthrosis as long as the indication for surgery is
clearly specified
• a minimal set of patient characteristics (age, gender, BMI, co-morbidity) and disease characteristics
(radiological severity, knee function and alignment, status of other knee or hip joints, previous surgeries of the
affected knee) is available.
• they are at least `up to date' in terms of follow-up of their respective study (i.e. the most recent examination was
less than a year ago and patients have apost-operative examination)
• they participated for at least three years in their respective study and have a usable MTPM-value (i.e. >_ 3 bonemarkers
can be consistently matched with the reference-examination with a CN < 120 over the most recent iwo
years of fol low-u p
• their standard RSA data meets the criteria as mentioned in the ISO-standard
• they are willing to participate and able to perform the 4 pre-set tasks for the inducible displacement
Patients will be excluded from participation if they do not meet the inclusion criteria, or if they already underwent
revision surgery of their TKR since the start of the study they were enrolled in.
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Maximum Total Point Motion (MTPM) in the 6 different RSA acquisitions positions
- Secondary Outcome Measures
Name Time Method Translation and Rotation along and about the 3 orthogonal axes in the 6 different RSA acquisition positions