Total Knee ReplacementNCT06062615
Robotic Assisted TKA
A study testing Total knee replacement using Omnibot Knee System, Conventional Total knee replacement and Omnibot Robotic Knee System in people with Total Knee Replacement, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Total knee replacement using Omnibot Knee System, Conventional Total knee replacement and Omnibot Robotic Knee System
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
- Diagnosis of primary osteoarthritis
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rothman Orthopaedic Institute
Philadelphia, Pennsylvania, 19107
About this study
Official title: Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty"
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
- Being tested
- Total knee replacement using Omnibot Knee System, Conventional Total knee replacement, Omnibot Robotic Knee System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total knee replacement using Omnibot Knee SystemProcedure or surgery
total knee replacement with robotic assistance
Conventional Total knee replacementProcedure or surgery
Conventional total knee replacement without robotic assistance
Omnibot Robotic Knee SystemDevice
utilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery
| Study group | Role | What they receive |
|---|---|---|
| Total knee replacement (TKR) without Omnibot system | Active comparator | The participant will undergo TKR utilizing conventional techniques. Receives: Procedure: Conventional Total knee replacement |
| Total knee replacement (TKR) with Omnibot | Active comparator | The participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System Receives: Procedure: Total knee replacement using Omnibot Knee System; Device: Omnibot Robotic Knee System |
What is being measured
The primary outcome is the main question the study is designed to answer.
early functional outcomes #1
This will be measured by the timed-up-and-go test.
Measured: 6 months
Early functional outcomes #2
This will be measured by the stair climbing test.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2023
- Study start1 Jul 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Total Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matt Austin, MD, Principal investigator, Rothman Orthopaedic Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06062615
- Sponsor's protocol ID
- MAUS 22D.103
- Status last verified
- Apr 2025
- First submitted
- 25 Sep 2023
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Lizcano JD, Restrepo S, Tarabichi S, Gold PA, Saxena A, Austin MS. Does the Use of a Robotic Gap-tensioning System Improve Functional Outcomes After TKA? A Randomized Clinical Trial. Clin Orthop Relat Res. 2026 Mar 1;484(3):533-543. doi: 10.1097/CORR.0000000000003734. Epub 2025 Oct 22.
PubMed 41191410
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Pilot Study Investigating Early Functional Outcomes With the Use of Robotic Assisted Versus Conventional Total Knee Arthroplasty"
- ClinicalTrials.gov ID
- NCT06062615
- Acronym / sponsor ID
- MAUS 22D.103
- Conditions
- Total Knee Replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 2 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total knee replacement (TKR) without Omnibot system | Active comparator | Procedure: Conventional Total knee replacementThe participant will undergo TKR utilizing conventional techniques. |
| Total knee replacement (TKR) with Omnibot | Active comparator | Procedure: Total knee replacement using Omnibot Knee System, Device: Omnibot Robotic Knee SystemThe participant will undergo a robotic assisted TKR utilizing the Omnibot Knee System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All unilateral primary knee arthroplasties performed by the investigator participating in this study will be eligible for inclusion
- Diagnosis of primary osteoarthritis
Key exclusion criteria (16 listed)
- Revision surgery
- Bilateral knee surgery
- Age <18 or >80
- BMI >40
- Baseline lower extremity strength less than 5/5
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total knee replacement using Omnibot Knee Systemtotal knee replacement with robotic assistance | Procedure or surgery | Total knee replacement (TKR) with Omnibot |
| Conventional Total knee replacementConventional total knee replacement without robotic assistance | Procedure or surgery | Total knee replacement (TKR) without Omnibot system |
| Omnibot Robotic Knee Systemutilizes an active motorized knee spacer to measure ligament tension and gap balance after the tibia has been cut during surgery | Device | Total knee replacement (TKR) with Omnibot |
Primary outcome
early functional outcomes #1
Time frame: 6 months
This will be measured by the timed-up-and-go test.
Early functional outcomes #2
Time frame: 6 months
This will be measured by the stair climbing test.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
- Derived from this study: PubMed 41191410Lizcano JD, Restrepo S, Tarabichi S, Gold PA, Saxena A, Austin MS. Does the Use of a Robotic Gap-tensioning System Improve Functional Outcomes After TKA? A Randomized Clinical Trial. Clin Orthop Relat Res. 2026 Mar 1;484(3):533-543. doi: 10.1097/CORR.0000000000003734. Epub 2025 Oct 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matt Austin, MD principal investigator
Rothman Orthopaedic Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total knee replacement using Omnibot Knee System, Conventional Total knee replacement and Omnibot Robotic Knee System in people with Total Knee Replacement, run by Rothman Institute Orthopaedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
early functional outcomes #1 (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06062615, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.