Persona MC Retained PCL vs. Persona Posterior-stabilized vs. NexGen PS
NCT04164147 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2021-08-02
Summary
This study compares and evaluates differences in movement analysis, patient-reported outcome and radiological assesment between patients undergoing total knee arthroplasty with use of either Zimmer Biomet NexGen and Zimmer Biomet PERSONA
Conditions
- Knee Osteoarthritis
- Knee Arthritis
- Joint; Arthrosis, Primary
Interventions
- PROCEDURE
-
Total knee replacement
Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
- DIAGNOSTIC_TEST
-
CT scan
CT scans of the affected knee joint before and after the surgical procedure
- DIAGNOSTIC_TEST
-
Biomechanics
Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
- DEVICE
-
one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant
Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis.
Sponsors & Collaborators
-
Medical University of Warsaw
lead OTHER
Principal Investigators
-
Artur Stolarczyk, PhD · Medical University of Warsaw
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-07-01
- Primary Completion
- 2021-12-01
- Completion
- 2022-12-31
Countries
- Poland
Study Locations
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