OsteoarthritisNCT02430129
Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
A study testing Total knee arthroplasty, Unicompartment knee arthroplasty and Persona in people with Osteoarthritis, run by Alberta Hip and Knee Clinic at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Total knee arthroplasty, Unicompartment knee arthroplasty and Persona
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- age 40-80 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the 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; 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=20) or TKA (n=20). 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.
- Conditions
- Osteoarthritis
- Being tested
- Total knee arthroplasty, Unicompartment knee arthroplasty, Persona, Oxford
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee arthroplastyProcedure or surgery
Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
Unicompartment knee arthroplastyProcedure or surgery
Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
PersonaDevice
Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
OxfordDevice
Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty/Persona | Active comparator | Total knee arthroplasty with Zimmer Persona posterior cruciate retaining prosthesis (Zimmer, Warsaw, IN) Receives: Procedure: Total knee arthroplasty; Device: Persona |
| Unicompartment knee arthroplasty/Oxford | Experimental | Unicompartmental knee arthroplasty with Biomet Oxford mobile-bearing unicompartmental knee prosthesis (Biomet, Warsaw, IN) Receives: Procedure: Unicompartment knee arthroplasty; Device: Oxford |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: 2 years
Oxford Knee Score (OKS)
Measured: 2 years
Secondary outcomes (1)
Gait analysis score
biomechanical and electromyography data
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startFeb 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alberta Hip and Knee Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Johnston, Alberta Hip and Knee Clinic
- Investigators
- Kelly D Johnston, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430129
- Sponsor's protocol ID
- REB14-0741
- Status last verified
- Dec 2021
- First submitted
- 22 Apr 2015
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kuntze G, Panjavi S, Henning E, Korley R, Abelseth G, Ronsky J, Johnston K. Preserving Patient-Specific Knee Motion: A Randomized Clinical Trial of Unicompartmental and Total Knee Arthroplasty. J Orthop Res. 2025 Dec;43(12):2203-2211. doi: 10.1002/jor.70077. Epub 2025 Oct 3.
PubMed 41044992
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unicondylar Knee Arthroplasty Versus Total Knee Arthroplasty in Patients With Anteromedial Osteoarthritis of the Knee
- ClinicalTrials.gov ID
- NCT02430129
- Acronym / sponsor ID
- REB14-0741
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Alberta Hip and Knee ClinicUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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; 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=20) or TKA (n=20). 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty/Persona | Active comparator | Procedure: Total knee arthroplasty, Device: PersonaTotal knee arthroplasty with Zimmer Persona posterior cruciate retaining prosthesis (Zimmer, Warsaw, IN) |
| Unicompartment knee arthroplasty/Oxford | Experimental | Procedure: Unicompartment knee arthroplasty, Device: OxfordUnicompartmental knee arthroplasty with Biomet Oxford mobile-bearing unicompartmental knee prosthesis (Biomet, Warsaw, IN) |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
- age 40-80 years
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee arthroplastyZimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN) | Procedure or surgery | Total knee arthroplasty/Persona |
| Unicompartment knee arthroplastyBiomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN) | Procedure or surgery | Unicompartment knee arthroplasty/Oxford |
| PersonaZimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN) | Device | Total knee arthroplasty/Persona |
| OxfordBiomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN) | Device | Unicompartment knee arthroplasty/Oxford |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 2 years
Oxford Knee Score (OKS)
Time frame: 2 years
1 secondary outcome
Gait analysis score
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Derived from this study: PubMed 41044992Kuntze G, Panjavi S, Henning E, Korley R, Abelseth G, Ronsky J, Johnston K. Preserving Patient-Specific Knee Motion: A Randomized Clinical Trial of Unicompartmental and Total Knee Arthroplasty. J Orthop Res. 2025 Dec;43(12):2203-2211. doi: 10.1002/jor.70077. Epub 2025 Oct 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly D Johnston, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee arthroplasty, Unicompartment knee arthroplasty and Persona in people with Osteoarthritis, run by Alberta Hip and Knee Clinic at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430129, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.