Robotic Assisted TKA

NCT ID: NCT06062615

Last Updated: 2025-05-04

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Replacement

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Total knee replacement (TKR) without Omnibot system

The participant will undergo TKR utilizing conventional techniques.

Group Type ACTIVE_COMPARATOR

Conventional Total knee replacement

Intervention Type PROCEDURE

Conventional total knee replacement without robotic assistance

Total knee replacement (TKR) with Omnibot

The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System

Group Type ACTIVE_COMPARATOR

Total knee replacement using Omnibot Knee System

Intervention Type PROCEDURE

total knee replacement with robotic assistance

Omnibot Robotic Knee System

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Total knee replacement using Omnibot Knee System

total knee replacement with robotic assistance

Intervention Type PROCEDURE

Conventional Total knee replacement

Conventional total knee replacement without robotic assistance

Intervention Type PROCEDURE

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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
* Diagnosis of primary osteoarthritis

Exclusion Criteria

* Revision surgery
* Bilateral knee surgery
* Age \<18 or \>80
* BMI \>40
* Baseline lower extremity strength less than 5/5
* History of chronic narcotic use, defined as more than 5mg of oxycodone q4 hours
* Functionally limiting spine disease
* Other functionally limiting lower extremity disorder (i.e. symptomatic ipsilateral hip disease)
* Patients who cannot perform the baseline functional tests
* Allergy/contraindication to protocol medications
* Post-traumatic arthritis
* Inflammatory arthritis
* Pregnancy
* Prisoners
* Patients receiving care as a result of a worker's compensable injury
* General anesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Rothman Institute Orthopaedics

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matt Austin, MD

Role: PRINCIPAL_INVESTIGATOR

Rothman Orthopaedic Institute

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Rothman Orthopaedic Institute

Philadelphia, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MAUS 22D.103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Computer Assisted Total Knee Replacement
NCT00279838 COMPLETED PHASE4
RSA Restoris MultiCompartmental Knee
NCT05417984 NOT_YET_RECRUITING