The aim of this prospective observational study is to assess the relation between femoral 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.The…
ID
Source
Brief title
Condition
- Joint disorders
- Bone and joint therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints of this study are (1) the change from baseline PROMs at
1-year follow-up, and (2) the degree of femoral, tibial and combined component
rotation.
The following PROMs will be used:
- Oxford Knee Score (OKS);
- Knee Injury and Osteoarthritis Outcome Score (KOOS);
- EQ-5D;
- VAS pain.
In addition, we will use the clinician-administered American Knee Society Score
(AKSS).
Secondary outcome
Secondary endpoints include the range of motion, and early revision because of
malposition.
Background summary
Total knee replacement (TKR) for osteoarthritis results in a satisfactory
outcome in the majority of patients. However, there is a large subgroup of
patients who are dissatisfied with the outcome and report persistent pain.
Potentially, surgically modifiable mechanical causes that can be modified
during surgery, such as component loosening, malalignment, and instability,
contribute to persistent pain.
Previous studies suggest that component malrotation could be the cause for
persistent pain and patellofemoral problems, but comprised a small number of
patients, and did not use PROMs. Therefore, a large prospective study is
needed to identify optimal rotational component alignment.
Our hypothesis is that there is a correlation between femoral and tibial
component rotation and functional outcomes as assessed with patient reported
outcomes.
Study objective
The aim of this prospective observational study is to assess the relation
between femoral 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.
The aim of the substudy is to verify whether rotation of the prosthesis is
determined by the anatomical rotation of the knee preoperatively, and secondary
whether this affects clinical results.
Study design
Single-center, prospective cohort study, invasive observational, and without
intervention.
Study burden and risks
A radiation dose (approximately 0.12 mSv) is associated with CT, which is
considered a negligible risk. Since follow-up moments are in line with
follow-up according to standard care, this will not result in additional burden
on patients.
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Nico Bolkesteinlaan 75
Deventer 7416SE
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
- Knee osteoarthritis;
- Informed consent for the surgical procedure;
- Signed informed consent for the study.
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
- Contra-indication for joint replacement surgery in general (pregnancy, active
infection, severe cardiac and respiratory comorbidities);
- Previous distal femoral or proximal tibial fracture resulting in an altered
anatomy;
- Previous osteotomies around the knee resulting in altered anatomy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL68333.075.18 |