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Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

NCT ID: NCT06858358

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-24

Study Completion Date

2026-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Knee Osteoarthristis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implant

Group Type EXPERIMENTAL

Robotic assisted total knee arthroplasty

Intervention Type PROCEDURE

• ROSA RATKA with Zimmer Biomet Persona Medial Congruent

Conventional TKA with Microport Evolution Medial-Pivot

Group Type EXPERIMENTAL

Conventional total knee arthroplasty (cTKA)

Intervention Type PROCEDURE

cTKA with Microport Evolution Medial-Pivot

Interventions

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Robotic assisted total knee arthroplasty

• ROSA RATKA with Zimmer Biomet Persona Medial Congruent

Intervention Type PROCEDURE

Conventional total knee arthroplasty (cTKA)

cTKA with Microport Evolution Medial-Pivot

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion Criteria

Patients who refuse participation in the study Low-grade osteoarthritis
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Iuliu Hatieganu University of Medicine and Pharmacy

OTHER

Sponsor Role collaborator

County Clinical Emergency Hospital Cluj-Napoca

OTHER

Sponsor Role collaborator

George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

OTHER

Sponsor Role lead

Responsible Party

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Marian Andrei Melinte

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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MedLife Humanitas Hospital

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Medicover Cluj Hospital

Cluj-Napoca, Cluj, Romania

Site Status RECRUITING

Countries

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Romania

Central Contacts

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Marian A Melinte

Role: CONTACT

[email protected]
+40 728 923 062

Razvan M Melinte, MD, PhD

Role: CONTACT

[email protected]
+40 722 331 327

Facility Contacts

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Razvan M Melinte, MD, PhD

Role: primary

[email protected]
+40 722 331 327

Horea Benea, MD, PhD

Role: primary

[email protected]
+40 724 528 188

Other Identifiers

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rosa_MP_MC_3002025

Identifier Type: -

Identifier Source: org_study_id

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