No registrations found.
ID
Source
Brief title
Health condition
Primary knee joint osteoarthritis
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change from baseline OKS at 1-year follow-up in relation to femoral, tibial, and combined component rotation.
Secondary outcome
Additional outcome measures include the Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D, VAS pain, the new American Knee Society Score (KSS, version 2011), knee joint range of motion, and complications (i.e. infection).
Background summary
Total knee replacement (TKR) for osteoarthritis results in a satisfactory outcome in the majority of patients, although up to one in five patients may be dissatisfied with the outcome. Persistent pain is a main contributor to patient dissatisfaction, and femoral and tibial component malrotation have been identified as a potential cause for both persistent pain and patellofemoral problems. Based on the assumption that component malrotation is the causative factor for persistent pain, early revision for patients with symptomatic malrotated components has been advocated in the literature. However, convincing evidence that component malrotation indeed causes less than optimal outcomes is lacking. This study aims to assess the relation between femoral, tibial, and combined component rotation and patient reported outcomes in a large group of patients, and to define a clear cut-off point for revision for malrotated components.
In this single-center, prospective observational cohort study, a total of 500 patients will undergo total knee replacement. All patients will have a 3D-CT assessment of femoral and tibial component rotation within 8 weeks after surgery. Outcome measures will include the Oxford Knee Score (OKS), Knee Injury and Osteoarthritis Outcome Score (KOOS), EQ-5D, VAS pain, the new American Knee Society Score (AKSS), knee joint range of motion, and complications. We will assess the relation between femoral, tibial, and combined component rotation and PROMs at 8 weeks and 1-year follow-up, and we will determine a cut-off point for the degree of component rotation that results in the best clinical outcomes.
Study objective
We hypothesize that there is a correlation between femoral, tibial, and combined component rotation and functional outcomes as assessed with PROMs.
Study design
Pre-operative, 8 weeks and 1-year post-operative.
Intervention
Total knee replacement
Inclusion criteria
- All mentally competent adult patients who will be treated with total knee replacement for primary knee osteoarthritis (Kellgren and Lawrence grade III or IV);
- Informed consent for the surgical procedure;
- Signed informed consent for the study.
Exclusion criteria
- Contra-indication for joint replacement surgery in general (pregnancy, active infection, severe cardiac and/or respiratory comorbidities);
- Previous distal femoral or proximal tibial fracture resulting in an altered anatomy;
- Previous osteotomies around the knee resulting in an altered anatomy.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7635 |
| CCMO | NL68333.075.18 |
| OMON | NL-OMON55865 |