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OpenTrials
Completed

NCT Number: NCT07212296

Randomized Controlled Trial Comparing Robotic-Assisted Versus Conventional Total Knee Arthroplasty

To evaluate whether patients undergoing robotic-assisted TKA achieve better clinical-functional, radiological, and satisfaction outcomes compared with those undergoing the conventional technique, and whether operative time and complications do not increase significantly

Completed

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Key information

Conditions

Knee Arthroplasty, Total Arthropathy of Knee Robotic Assisted Arthroplasty

Age range

54 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital de Terrassa - Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

About this study

To compare clinical, functional, quality-of-life, and radiological outcomes between robotic-assisted total knee arthroplasty (RA-TKA) and conventional total knee arthroplasty (C-TKA).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with knee arthropaty recquiring TKR

Exclusion criteria

  • Cognitive disease
  • Deformity greater than 15º of varus or 10º of valgus
  • Postraumatic arthritis
  • Inflamatory disease
  • Other than "Persona PS" implant design
  • Previus surgery

Treatment and study plan

Conventional Total knee replacement

Procedure

Knee replacement without robotic technology

Robotic TKR

Procedure

Total knee replacement WITH robotic technology

Primary outcomes

  1. IKDC

    Time frame: 2 years follow up after surgery

    standardized international system for documenting and evaluating knee problems. The IKDC Subjective Knee Form is a patient-reported outcome measure that was developed to assess both surgical and non-surgical outcomes across a wide range of knee conditions and treatment approaches.

Sponsors and collaborators

Lead sponsor

Hospital de Terrassa

Other

Registry information

Official study title

Robotic-Assisted Versus Conventional Total Knee Arthroplasty: A Randomized Controlled Trial With 2-Year Follow-Up

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2025
Registry last updated
Oct 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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