Knee Osteoarthristis
Conditions
Keywords
Robotic, Knee arthroplasty, TKA, ROSA
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.
Interventions
• ROSA RATKA with Zimmer Biomet Persona Medial Congruent
PROCEDUREConventional total knee arthroplasty (cTKA)
cTKA with Microport Evolution Medial-Pivot
Sponsors
Iuliu Hatieganu University of Medicine and Pharmacy
County Clinical Emergency Hospital Cluj-Napoca
George Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
Patients with severe osteoarthritis (greater than III Ahlback)
Exclusion criteria
Patients who refuse participation in the study Low-grade osteoarthritis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mechanical axis outliers | Perioperative/ Periprocedural | Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray |
| Polyethylene insert thickness | Perioperative/ Periprocedural | Insert Thickness: Measured and analyzed in millimeters |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International knee documentation committe (IKDC) subjective score | 3, 6, and 12 months post-operative | The IKDC is a purely subjective assessment that assigns patients a functional overall rating. Three (3) categories are examined by the questionnaire: symptoms, athletic activity, and knee function. The symptoms subscale aids in evaluating issues like pain, stiffness, edema, and knee giving way. The ICC, which varies from 0.87 to 0.98, was deemed sufficient (\>0.70). Overall, it was discovered that the IKDC-SKF has positive test-retest reliability (Grevnerts et al. 2015). The IKDC subjective form scored acceptable for construct validity (84% confirmation of the predefined hypotheses) and responsiveness (86% confirmation of the predefined hypotheses) (van Meer et al. 2015). |
| Forgotten joint score-12 (FJS-12) | 3, 6, and 12 months post-operative | The primary objective of the FJS-12 is to evaluate the extent to which patients forget their artificial joints during daily activities. A higher score indicates that the patient is less aware of their joint, suggesting better surgical outcomes and higher levels of patient satisfaction. |
Countries
Romania
Contacts
Primary ContactMarian A Melinte
Backup ContactRazvan M Melinte, MD, PhD
Outcome results
None listed