Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
Information source: Alberta Hip and Knee Clinic
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Total knee arthroplasty (Procedure); Unicompartment knee arthroplasty (Procedure); Persona (Device); Oxford (Device)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Alberta Hip and Knee Clinic Official(s) and/or principal investigator(s): Kelly D Johnston, MD, Principal Investigator, Affiliation: University of Calgary, Cumming School of Medicine
Overall contact: Kelly D Johnston, MD, Phone: 403 266 3497, Email: kelly.johnston0@gmail.com
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.
Clinical Details
Official title: Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)Oxford Knee Score (OKS)
Secondary outcome: Gait analysis score
Detailed 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.
Eligibility
Minimum age: 40 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Anteromedial compartment osteoarthritis (OA) with intact anterior cruciate ligament
(ACL) by clinical testing and alignment on radiographs;
- normal or mild to moderate patellofemoral joint OA
- angular deformity <15 degrees passively correctible to neutral;
- flexion contracture<5 degrees;
- BMI<40;
- age 40-80 years
Exclusion Criteria:
- 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
Locations and Contacts
Kelly D Johnston, MD, Phone: 403 266 3497, Email: kelly.johnston0@gmail.com Additional Information
Starting date: May 2015
Last updated: April 25, 2015
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