Knee ArthritisNCT03052790
Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
A study testing manually instrumented total knee arthroplasty and robotic assisted total knee arthroplasty in people with Knee Arthritis, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 25 to 95 years
- Conditions the study is for
- Knee Arthritis
- What is being tested?
- manually instrumented total knee arthroplasty and robotic assisted total knee arthroplasty
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 1 Dec 2019
- 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 25 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have knee pain and are candidates for total knee arthroplasty
- Patients able to consent to be included in the study
Who cannot join
- Patients with previous total or partial knee arthroplasty in need of revision surgery
- Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at Houston
Houston, Texas, 70043
About this study
The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.
- Conditions
- Knee Arthritis
- Being tested
- manually instrumented total knee arthroplasty, robotic assisted total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
manually instrumented total knee arthroplastyProcedure or surgery
Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
robotic assisted total knee arthroplastyDevice
Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.
| Study group | Role | What they receive |
|---|---|---|
| manually instrumented total knee arthroplasty | Active comparator | Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut. Receives: Procedure: manually instrumented total knee arthroplasty |
| robotic assisted total knee arthroplasty | Experimental | Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts. Receives: Device: robotic assisted total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.
Measured: within 2 weeks before surgery, within one month of surgery
Secondary outcomes (16)
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: within 2 weeks before surgery
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: 3 months after surgery
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: 6 months after surgery
Pain as assessed by the PROMIS 10 measurement system
Patient-Reported Outcomes Measurement Information System (PROMIS)
Measured: 1 year after surgery
Function as assessed by the PROMIS 10 measurement system
Measured: within 2 weeks before surgery
Function as assessed by the PROMIS 10 measurement system
Measured: 3 months after surgery
Function as assessed by the PROMIS 10 measurement system
Measured: 6 months after surgery
Function as assessed by the PROMIS 10 measurement system
Measured: 1 year after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Measured: within 2 weeks before surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Measured: 3 months after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Measured: 6 months after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Measured: 1 year after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Measured: within 2 weeks before surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Measured: 3 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Measured: 6 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Pain is rated on a scale of 0 to 10, with 10 being the highest level of pain.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Jul 2018 (estimated)
- Primary completion1 Jul 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Why it stopped: lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthritisStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam M Freedhand, The University of Texas Health Science Center, Houston
- Investigators
- Adam Freedhand, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052790
- Sponsor's protocol ID
- HSC-MS-16-1096
- Status last verified
- Apr 2019
- First submitted
- 9 Feb 2017
- Last updated
- 4 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Implant Positioning With Robotic Aided Surgery and Traditional Jig Positioning in Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03052790
- Acronym / sponsor ID
- HSC-MS-16-1096
- Conditions
- Knee Arthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 14 Feb 2017 (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.
The purpose of this study is to compare the outcomes and accuracy of implant positioning in robotic assisted total knee arthroplasty with traditional manually instrumented total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| manually instrumented total knee arthroplasty | Active comparator | Procedure: manually instrumented total knee arthroplastyManually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut. |
| robotic assisted total knee arthroplasty | Experimental | Device: robotic assisted total knee arthroplastyRobotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts. |
Who may qualify
- Ages
- 25 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who have knee pain and are candidates for total knee arthroplasty
- Patients able to consent to be included in the study
Key exclusion criteria (2 listed)
- Patients with previous total or partial knee arthroplasty in need of revision surgery
- Patients unable to or unwilling to undergo post-operative CT scans after understanding the risks and benefits
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 |
|---|---|---|
| manually instrumented total knee arthroplastyManually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut. | Procedure or surgery | manually instrumented total knee arthroplasty |
| robotic assisted total knee arthroplastyRobotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts. | Device | robotic assisted total knee arthroplasty |
Primary outcome
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT)
Time frame: within 2 weeks before surgery, within one month of surgery
The absolute value of the individual differences in various angle measurements will be added together to form a total summation of angle difference.
16 secondary outcomes
Pain as assessed by the PROMIS 10 measurement system
Time frame: within 2 weeks before surgery
Pain as assessed by the PROMIS 10 measurement system
Time frame: 3 months after surgery
Pain as assessed by the PROMIS 10 measurement system
Time frame: 6 months after surgery
Pain as assessed by the PROMIS 10 measurement system
Time frame: 1 year after surgery
Function as assessed by the PROMIS 10 measurement system
Time frame: within 2 weeks before surgery
Function as assessed by the PROMIS 10 measurement system
Time frame: 3 months after surgery
Function as assessed by the PROMIS 10 measurement system
Time frame: 6 months after surgery
Function as assessed by the PROMIS 10 measurement system
Time frame: 1 year after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time frame: within 2 weeks before surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time frame: 3 months after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time frame: 6 months after surgery
Knee injury and Osteoarthritis as assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) measurement system
Time frame: 1 year after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: within 2 weeks before surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: 3 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: 6 months after surgery
Pain as assessed by a Visual Analogue Scale (VAS)
Time frame: 1 year after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2019.
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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.
Adam Freedhand, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing manually instrumented total knee arthroplasty and robotic assisted total knee arthroplasty in people with Knee Arthritis, run by The University of Texas Health Science Center, Houston 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 2 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: withdrawn, as of the sponsor's last update on 4 Apr 2019. 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 was withdrawn before enrolling participants, so there are no results.
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?
Summation of angle differences between pre-operative plan and the final implant position as indicated by computed tomography (CT) (time frame: within 2 weeks before surgery, within one month of surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2019.