Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
Primary Purpose
Osteoarthritis
Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Total knee arthroplasty
Unicompartment knee arthroplasty
Persona
Oxford
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis
Eligibility 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
Sites / Locations
- Alberta Hip and Knee Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Total knee arthroplasty/Persona
Unicompartment knee arthroplasty/Oxford
Arm Description
Total knee arthroplasty with Zimmer Persona posterior cruciate retaining prosthesis (Zimmer, Warsaw, IN)
Unicompartmental knee arthroplasty with Biomet Oxford mobile-bearing unicompartmental knee prosthesis (Biomet, Warsaw, IN)
Outcomes
Primary Outcome Measures
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Oxford Knee Score (OKS)
Secondary Outcome Measures
Gait analysis score
biomechanical and electromyography data
Full Information
NCT ID
NCT02430129
First Posted
April 22, 2015
Last Updated
February 8, 2021
Sponsor
Alberta Hip and Knee Clinic
1. Study Identification
Unique Protocol Identification Number
NCT02430129
Brief Title
Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
Official Title
Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alberta Hip and Knee Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Total knee arthroplasty/Persona
Arm Type
Active Comparator
Arm Description
Total knee arthroplasty with Zimmer Persona posterior cruciate retaining prosthesis (Zimmer, Warsaw, IN)
Arm Title
Unicompartment knee arthroplasty/Oxford
Arm Type
Experimental
Arm Description
Unicompartmental knee arthroplasty with Biomet Oxford mobile-bearing unicompartmental knee prosthesis (Biomet, Warsaw, IN)
Intervention Type
Procedure
Intervention Name(s)
Total knee arthroplasty
Intervention Description
Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
Intervention Type
Procedure
Intervention Name(s)
Unicompartment knee arthroplasty
Intervention Description
Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
Intervention Type
Device
Intervention Name(s)
Persona
Intervention Description
Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
Intervention Type
Device
Intervention Name(s)
Oxford
Intervention Description
Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
Primary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time Frame
2 years
Title
Oxford Knee Score (OKS)
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Gait analysis score
Description
biomechanical and electromyography data
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly D Johnston, MD
Organizational Affiliation
University of Calgary Cumming School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alberta Hip and Knee Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2P 3C5
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
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