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Robotic Assisted TKA

NCT06062615 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-04

No results posted yet for this study

Summary

As an intraoperative tool, a modern robotic total knee arthroplasty (TKA) system should be able to identify a patient's native femoral and tibial anatomy, as well as, assess ligament tension and gap balance. The surgeon in real time is then able to develop and execute a patient specific plan in terms of component size, alignment and rotation. In our institution we have begun to use, the OMNIBotics Knee system (Corin), which utilizes an active motorized knee spacer, BalanceBot, to objectively measure ligament tension and gap balance after the tibia has been cut and its alignment confirmed. This information is then processed through the OMNIbotics computer algorithm to appropriately size, align, and rotate the femur component to balance the flexion and extension gaps. The purpose of this study is to perform a randomized pilot study looking for an effect on early functional outcomes comparing robotic assisted TKA (RATKA) versus conventional TKA technique.

Conditions

  • Total Knee Replacement

Interventions

PROCEDURE

Total knee replacement using Omnibot Knee System

total knee replacement with robotic assistance

PROCEDURE

Conventional Total knee replacement

Conventional total knee replacement without robotic assistance

DEVICE

Omnibot Robotic Knee System

utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery

Sponsors & Collaborators

  • Rothman Institute Orthopaedics

    lead OTHER

Principal Investigators

  • Matt Austin, MD · Rothman Orthopaedic Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-01
Primary Completion
2023-12-31
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06062615 on ClinicalTrials.gov