Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Robotic assisted total knee arthroplasty, Conventional total knee arthroplasty (cTKA).
- Who it may be relevant to
- Registry conditions: Knee Osteoarthristis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Romania
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
Overview
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.
Detailed description
This prospective, non-randomized, multicenter trial evaluates robotic-assisted (ROSA® Robotic Platform with Zimmer Biomet Persona® Medial Congruent) versus conventional (MicroPort Evolution® Medial-Pivot) total knee arthroplasty (TKA) in approximately 300 adults with severe osteoarthritis. By comparing robotic precision with a well-established Medial-Pivot design, this investigation aims to clarify whether robotic-assisted TKA confers superior implant positioning, reduced alignment outliers, and enhanced patient-reported outcomes (PROMS). The primary outcome measures include insert thickness, alignment accuracy (outliers defined as \>2° from the mechanical axis on full-leg radiographs), and patient satisfaction at 6 and 12 months. Two surgeons will perform both techniques, and one surgeon will perform only the conventional procedure. The 18-month study is conducted under local Institutional Review Board approvals (Medlife, Medicover, SCJU Cluj Napoca, Monza Bucuresti) and complies with GDPR. Results are intended for publication in a high-impact orthopedic journal. No external funding is provided.
Interventions
- Procedure Robotic assisted total knee arthroplasty
• ROSA RATKA with Zimmer Biomet Persona Medial Congruent - Procedure Conventional total knee arthroplasty (cTKA)
cTKA with Microport Evolution Medial-Pivot
Primary outcome measures
- Polyethylene insert thickness [Time frame: Perioperative/ Periprocedural]
- Mechanical axis outliers [Time frame: Perioperative/ Periprocedural]
Secondary outcome measures (2)
- International knee documentation committe (IKDC) subjective score [Time frame: 3, 6, and 12 months post-operative]
- Forgotten joint score-12 (FJS-12) [Time frame: 3, 6, and 12 months post-operative]
Eligibility criteria
Inclusion criteria
Patients with severe osteoarthritis (greater than III Ahlback)
Exclusion criteria
Patients who refuse participation in the study Low-grade osteoarthritis
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Romania · 2 centers
- MedLife Humanitas Hospital — Cluj-Napoca
- Medicover Cluj Hospital — Cluj-Napoca
Identifiers
NCT: NCT06858358 · rosa_MP_MC_3002025