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

H

Hospital de Terrassa

Status

Completed

Conditions

Robotic Assisted Arthroplasty
Knee Arthroplasty, Total
Arthropathy of Knee

Treatments

Procedure: Robotic TKR
Procedure: Conventional total knee replacement

Study type

Interventional

Funder types

Other

Identifiers

NCT07212296
01-21-105-058

Details and patient eligibility

About

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

Full description

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).

Enrollment

95 patients

Sex

All

Ages

54 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

95 participants in 2 patient groups, including a placebo group

Conventional total knee replacement
Placebo Comparator group
Description:
PAtietns undergoing conventional TKR
Treatment:
Procedure: Conventional total knee replacement
Robotic TKR
Experimental group
Description:
PAtietns undergoing robotic TKR
Treatment:
Procedure: Robotic TKR

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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