NCT07212296

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2021

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2025

Completed
Last Updated

October 8, 2025

Status Verified

October 1, 2025

Enrollment Period

3.4 years

First QC Date

October 1, 2025

Last Update Submit

October 1, 2025

Conditions

Knee Arthroplasty, TotalRobotic Assisted ArthroplastyArthropathy of Knee

Keywords

RoboticArthroplasty

Outcome Measures

Primary Outcomes (1)

  • IKDC

    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.

    2 years follow up after surgery

Study Arms (2)

Conventional total knee replacement

PLACEBO COMPARATOR

PAtietns undergoing conventional TKR

Procedure: Conventional total knee replacement

Robotic TKR

EXPERIMENTAL

PAtietns undergoing robotic TKR

Procedure: Robotic TKR

Interventions

Conventional total knee replacementPROCEDURE

Knee replacement without robotic technology

Conventional total knee replacement
Robotic TKRPROCEDURE

Total knee replacement WITH robotic technology

Robotic TKR

Eligibility Criteria

Age54 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with knee arthropaty recquiring TKR

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de Terrassa - Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

Location

Study Officials

  • Javier Alonso-Rodriguez Piedra, Orthopaedic Surgeon, MdPhD

    Hospital de Terrassa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Knee Unit Surgeon

Study Record Dates

First Submitted

October 1, 2025

First Posted

October 8, 2025

Study Start

June 1, 2021

Primary Completion

October 31, 2024

Study Completion

October 31, 2024

Last Updated

October 8, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)