Clinical trial NCT06858358: Robotic Medial Congruent Vs. Conventional Medial Pivot TKA
Official title: Comparison of Robotic-Assisted Medial Congruent and Conventional Medial Pivot Total Knee Arthroplasty: a Prospective, Multicenter Analysis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Knee Osteoarthristis
Keywords: Robotic
Knee arthroplasty
TKA
ROSA
Lead sponsor: George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Sponsor class: OTHER
Collaborators: name: Iuliu Hatieganu University of Medicine and Pharmacy
name: County Clinical Emergency Hospital Cluj-Napoca
First posted: 2025-03-05
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

Patients with severe osteoarthritis (greater than III Ahlback)

Exclusion Criteria:

Patients who refuse participation in the study Low-grade osteoarthritis

Primary outcomes:
measure: Polyethylene insert thickness
timeFrame: Perioperative/ Periprocedural
measure: Mechanical axis outliers
timeFrame: Perioperative/ Periprocedural
Secondary outcomes:
measure: International knee documentation committe (IKDC) subjective score
timeFrame: 3, 6, and 12 months post-operative
measure: Forgotten joint score-12 (FJS-12)
timeFrame: 3, 6, and 12 months post-operative
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: MedLife Humanitas Hospital
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Medicover Cluj Hospital
state: Cluj
Study officials:
References: