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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07212296
Enrollment
95
Registered
2025-10-08
Start date
2021-06-01
Completion date
2024-10-31
Last updated
2025-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthropathy of Knee, Knee Arthroplasty, Total, Robotic Assisted Arthroplasty

Keywords

Robotic, Arthroplasty

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

Detailed 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).

Interventions

Knee replacement without robotic technology

PROCEDURERobotic TKR

Total knee replacement WITH robotic technology

Sponsors

Hospital de Terrassa
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
54 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
IKDC2 years follow up after surgerystandardized 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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026