Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02430129 |
| Other study ID # |
REB14-0741 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 2016 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Alberta Hip and Knee Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
This study is a randomized controlled trial comparing total knee arthroplasty (TKA) to
unicompartmental knee arthroplasty (UKA) in patients with no to moderate anteromedial knee
osteoarthritis. TKA patients will receive the Zimmer Persona (Warsaw, IN) posterior cruciate
retaining total knee arthroplasty, while UKA patients will receive the Biomet Oxford (Warsaw,
IN) mobile bearing unicompartmental knee arthroplasty.
Outcome measures will include Western Ontario and McMaster University Osteoarthritis Index
(WOMAC) and Oxford Knee Score (OKS) questionnaires, as well as biomechanics and EMG analysis
from the investigating gait lab.
The investigators hypothesize that post-operative UKA patients will display higher clinical
scores using WOMAC and OKS questionnaires, and superior biomechanical analysis measures. The
investigators further hypothesize that the biomechanics data will assist in the understanding
of the outcome score differential both pre- and post-operatively in both groups, as well as
between-groups.
Total follow up period will be two years.
Description:
Title:
Unicondylar knee arthroplasty versus total knee arthroplasty in patients with anteromedial
osteoarthritis of the knee.
Rationale:
Unicompartmental knee arthroplasty (UKA) offers several possible advantages over total knee
arthroplasty (TKA). One important possible advantage is overall higher patient satisfaction
with UKA. Patients have superior post-operative range of motion and a more "natural-feeling"
knee. Previously, patients with patellofemoral joint osteoarthritis (PFJOA) were excluded
from UKA. However, recent studies suggest that excellent results can be achieved with UKA
despite pre-existing moderate PFJOA. This may broaden pre-defined inclusion criteria for UKA.
To date, no biomechanical studies directly comparing UKA and TKA have been performed.
Biomechanical data could help explain outcome differences. This study aims to compare both
clinical and biomechanical outcomes in patients receiving UKA versus TKA for anteromedial OA
in the presence of no to moderate PFJOA.
Hypothesis:
We hypothesize that post-operative UKA patients will display higher clinical scores using
WOMAC and OKS questionnaires, and superior biomechanical analysis measures. In comparing to
healthy controls, we expect to see UKA patients perform more closely to controls than TKA
patients, with regards to WOMAC, OKS, and biomechanical scores. We further hypothesize that
UKA patients will have larger changes in WOMAC and OKS scores pre- to post-operatively than
TKA patients.
Study design:
This study is a randomized controlled trial. Eligible patients have: anteromedial compartment
osteoarthritis (OA) with intact anterior cruciate ligament (ACL) by clinical testing and
alignment on radiographs; normal or mild to moderate PFJOA; angular deformity <15 degrees
passively correctible to neutral; flexion contracture<5 degrees; BMI<40; age 40-80 years. We
exclude patients with: severe PFJOA; history of previous surgery on the affected knee
(excluding simple meniscectomy); inflammatory arthropathy; previous contralateral knee
replacement surgery or major ligament reconstruction surgery. Patients will be stratified
based on their PFJOA status. They will be randomized using StudyTRAX (ScienceTrax, Macon, GA)
online system to one of two treatment arms: UKA (n=19) or TKA (n=19). The control group will
be matched to study group characteristics, and recruited through University of Calgary and
Alberta Hip and Knee Clinic (AHKC). UKA patients will receive a mobile bearing, Oxford UKA
(Biomet, Warsaw, IN) utilizing microplasty instrumentation. TKA patients will receive a
posterior cruciate-retaining TKA with unresurfaced patella utilizing Persona instrumentation
(Zimmer, Warsaw, IN). Clinical outcomes will be assessed pre-operatively, and
post-operatively at 6 weeks, 3 months, 1 year, and 2 years utilizing the WOMAC and OKS
questionnaires. Radiographs include weight bearing anteroposterior (AP), AP, lateral and
skyline views, and valgus stress views. These are standard to treatment at AHKC, and will be
taken preoperatively and at the 2 day (non-weightbearing views only), 3 month, and 1 year
postoperative appointments. Interpretation will be by the treating surgeons.Biomechanical
assessment will include gait analysis and electromyography (EMG), and will be done at the
Clinical Movement Analysis Laboratory (CMAL) at the McCaig Institute. This will be measured
pre-operatively and at one year post-operatively. A healthy, age, gender and weight matched
control group will be recruited to establish deviations of the patient groups from the
healthy norm. Clinical and biomechanical outcomes will be assessed only once for the control
group.
The analysis plan includes descriptive analyses, univariate analysis to explore between-group
differences and repeated-measures ANOVA to assess statistically significant changes in WOMAC,
OKS, and biomechanical outcomes over time within both groups. T-test & Pearson chi-square
test will be computed for all continuous variables and categorical variables, accordingly. A
multivariate linear regression analysis may be performed to reveal relationships between
variables, enabling us to control for baseline variables of interest.
Significance of work:
No studies to date have investigated whether UKA or TKA is favorable in patients with no to
moderate PFJOA, but who meet all other traditional criteria for UKA. Additionally, no
biomechanical data exists in this area. If patients receiving UKA demonstrate similar (or
better) clinical and biomechanical outcomes to those receiving TKA, then it would suggest
that UKA could be offered to a much greater number of patients, as a less invasive procedure,
with potential health system savings. It is anticipated that the biomechanical data, in
combination with the clinical research data, will help to better understand the differences
between these two surgical approaches.
