Health TrialsbyHealthPanel

Robotic Medial Congruent Vs. Conventional Medial Pivot TKA

ConditionKnee Osteoarthristis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorGeorge Emil Palade University of Medicine, Pharmacy, Sciences and Technology of Targu Mures

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Robotic assisted total knee arthroplasty

    Procedure/Surgery

    • ROSA RATKA with Zimmer Biomet Persona Medial Congruent

  • Conventional total knee arthroplasty (cTKA)

    Procedure/Surgery

    cTKA with Microport Evolution Medial-Pivot

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: ROSA Robotic-assisted TKA with Zimmer Biomet Persona Medial Congruent implantExperimental treatment 1 intervention
Group B: Conventional TKA with Microport Evolution Medial-PivotExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Polyethylene insert thickness

Insert Thickness: Measured and analyzed in millimeters

Time frame
Perioperative/ Periprocedural
2

Mechanical axis outliers

Outliers: Defined as more than 2.0 degrees from mechanical alignment, measured on full-leg X-ray

Time frame
Perioperative/ Periprocedural

Secondary outcomes

1

International knee documentation committe (IKDC) subjective score

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).

Time frame
3, 6, and 12 months post-operative
2

Forgotten joint score-12 (FJS-12)

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.

Time frame
3, 6, and 12 months post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Collaborator

County Clinical Emergency Hospital Cluj-Napoca

Collaborator

Source ClinicalTrials.gov
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