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

NCT ID: NCT07212296

Last Updated: 2025-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2024-10-31

Brief Summary

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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

Detailed Description

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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).

Conditions

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Knee Arthroplasty, Total Robotic Assisted Arthroplasty Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Conventional total knee replacement

PAtietns undergoing conventional TKR

Group Type PLACEBO_COMPARATOR

Conventional total knee replacement

Intervention Type PROCEDURE

Knee replacement without robotic technology

Robotic TKR

PAtietns undergoing robotic TKR

Group Type EXPERIMENTAL

Robotic TKR

Intervention Type PROCEDURE

Total knee replacement WITH robotic technology

Interventions

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Conventional total knee replacement

Knee replacement without robotic technology

Intervention Type PROCEDURE

Robotic TKR

Total knee replacement WITH robotic technology

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

54 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Terrassa

OTHER

Sponsor Role lead

Responsible Party

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Javier Alonso

Knee Unit Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Javier Alonso-Rodriguez Piedra, Orthopaedic Surgeon, MdPhD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Terrassa

Locations

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Hospital de Terrassa - Consorci Sanitari de Terrassa

Terrassa, Barcelona, Spain

Site Status

Countries

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Spain

Other Identifiers

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01-21-105-058

Identifier Type: -

Identifier Source: org_study_id

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