Study Summary
This trial will compare the accuracy of two different ways of performing a knee replacement surgery.
Eligible Conditions
- Osteoarthritis
- Bow Legs
- Osteoarthritis of the Knee
- Chronic Knee Pain
- Posttraumatic Osteoarthritis
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: 24 Months
24 Months
Numeric Pain Rating Scale (NPRS)
Subject Satisfaction
24 months
Evaluation of Instability
Evaluation of Patient safety
Evaluation of range of motion
Patient Reported Outcome Measure (KOOS-12)
Patient Reported Outcome Measure (Oxford Knee Score)
6 Weeks
Accuracy of implant position
Trial Safety
Safety Progress
Trial Design
2 Treatment Groups
Traditional/Conventional UKA
1 of 2
Robotic-Assisted UKA
1 of 2
Active Control
180 Total Participants · 2 Treatment Groups
Primary Treatment: Traditional/Conventional UKA · No Placebo Group · N/A
Traditional/Conventional UKA
Device
ActiveComparator Group · 1 Intervention: Persona Partial Knee System · Intervention Types: DeviceRobotic-Assisted UKA
Device
ActiveComparator Group · 1 Intervention: Persona Partial Knee System · Intervention Types: DeviceTrial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Who is running the clinical trial?
Zimmer BiometLead Sponsor
363 Previous Clinical Trials
65,547 Total Patients Enrolled
125 Trials studying Osteoarthritis
32,032 Patients Enrolled for Osteoarthritis
Kacy ArnoldStudy DirectorZimmer Biomet
10 Previous Clinical Trials
2,190 Total Patients Enrolled
1 Trials studying Osteoarthritis
388 Patients Enrolled for Osteoarthritis
Erin OsbornStudy DirectorZimmer Biomet
10 Previous Clinical Trials
11,446 Total Patients Enrolled
3 Trials studying Osteoarthritis
10,886 Patients Enrolled for Osteoarthritis
Hillary OverholserStudy DirectorZimmer Biomet
7 Previous Clinical Trials
1,524 Total Patients Enrolled
4 Trials studying Osteoarthritis
890 Patients Enrolled for Osteoarthritis
Eligibility Criteria
Age Any Age · All Participants · 8 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Your body mass index (BMI) is less than or equal to 40 kg/m2.
Frequently Asked Questions
Is there an ongoing recruitment drive for this clinical trial?
"Clinicaltrials.gov confirms that this trial is not presently recruiting patients, as it was most recently updated on May 5th 2022 since being posted on January 1st 2023. However, there are currently 797 other medical studies actively enrolling participants at the present time." - Anonymous Online Contributor
Unverified Answer