Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
1 other identifier
interventional
300
1 country
2
Brief Summary
This multicenter, prospective cohort study will evaluate whether Robotic-Assisted total knee arthroplasty (RATKA) with a Medial Congruent implant is a successful method to improve implant alignment, insert thickness accuracy, and patient satisfaction, compared to a conventional TKA (cTKA) Medial Pivot technique. It aims to assess and compare clinical and functional outcomes in patients with severe knee osteoarthritis at 3, 6, and 12 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2025
CompletedStudy Start
First participant enrolled
February 24, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2026
March 5, 2025
February 1, 2025
1.3 years
February 21, 2025
February 27, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Polyethylene insert thickness
Insert Thickness: Measured and analyzed in millimeters
Perioperative/ Periprocedural
Mechanical axis outliers
Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray
Perioperative/ Periprocedural
Secondary Outcomes (2)
International knee documentation committe (IKDC) subjective score
3, 6, and 12 months post-operative
Forgotten joint score-12 (FJS-12)
3, 6, and 12 months post-operative
Study Arms (2)
ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant
EXPERIMENTALConventional TKA with Microport Evolution Medial-Pivot
EXPERIMENTALInterventions
• ROSA RATKA with Zimmer Biomet Persona Medial Congruent
cTKA with Microport Evolution Medial-Pivot
Eligibility Criteria
You may qualify if:
- Patients with severe osteoarthritis (greater than III Ahlback)
You may not qualify if:
- Patients who refuse participation in the study Low-grade osteoarthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
MedLife Humanitas Hospital
Cluj-Napoca, Cluj, 400664, Romania
Medicover Cluj Hospital
Cluj-Napoca, Cluj, 407062, Romania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 21, 2025
First Posted
March 5, 2025
Study Start
February 24, 2025
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
September 1, 2026
Last Updated
March 5, 2025
Record last verified: 2025-02