ArthritisNCT03447626
UKA Manual Versus UKA MAKO Robotic
An observational study of Arthritis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthritis
- What is being tested?
- MAKO Robotic UKA
- Type of treatment
- Medical device
- How many people
- 486 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2019to 7 Apr 2024
- Phase
- Observational
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Unilateral arthroplasty knee patients and total Knee arthroplasty patients
Who may be able to join
- All patients who receive a robotic arm assisted UKA using the RIO navigation system will be prospectively included. All patients who have received a medial fixed or mobile UKA performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed. Also, all TKAs from a pervious study (IRB 201308057) performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed as well.
- Patient is willing and able to comply with postoperative follow-up requirements and self-evaluations
- Patient is willing to sign an IRB approved informed consent
- Patient is at least 18 years of age
Who cannot join
- • Patient has a BMI < 40
- Patient is skeletally immature
- Patient has an active infection or suspected infection in or about the joint
- Bone stock that is inadequate to support fixation of the prosthesis
- Neuromuscular disorders, muscular atrophy or vascular deficiency in the affected limb rendering the procedure unjustified.
- Patients with mental or neurological conditions which may be incapable of following instructions.
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- Blood supply limitations
- Collateral ligament insufficiency.
- Patients with prior HTOs or Unis.
- Patients requiring bilateral knee arthroplasty.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Market Study of Robotic-Arm Assisted Unicompartmental Knee Arthroplasty in Comparison to Traditional UKA (Fixed and Mobile Bearings)
The purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice and compare it to historical data on manual UKAs and TKAs.
Read the detailed description
Total knee arthroplasty (TKA) is known to have excellent long-term survivorship and clinical success in the management of degenerative joint disease, and remains the primary treatment for patients with bi- or tri-compartmental osteoarthritis. However, the patient population seeking knee arthroplasty is evolving, with patients being younger and more demanding on their prostheses (1). Recent investigations have highlighted that there remains a high incidence of residual symptoms including grinding/popping/clicking, swelling, and difficulties getting in and out of a car and chair, and 16% of patients remain "unsatisfied" following TKA (1).
Medial unicompartmental knee arthroplasty (UKA) remains a viable alternative to total knee arthroplasty in patients presenting with isolated, medial compartment osteoarthritis of the knee. Its use has increased in popularity in the United States, as the number of UKA performed over the last decade has increased by 30%(1). Proposed benefits of UKA include a smaller incision, less blood loss as well as shorter recovery time to functional level. Other benefits of UKAs include improved knee range of motion and better restoration of the knee kinematics (2, 5). These benefits are attributed to the less invasive nature of the procedure with preservation of the anterior and posterior cruciate ligaments, and minimal bony resections.
Unfortunately, historically the survival rate of UKA has been poor, with several reports demonstrating a survival rate of only 65-70% at 7-10 year follow-up (8, 9). These historically poor results have been attributed to instrumentation that was difficult to use, poor indications for the surgical procedure, and inadequate implant designs. More recent reports have shown 10-year survival rates ranging from 91% to 98% using both mobile-bearing and fixed-bearing UKA designs (7, 10-12). Mobile bearing UKA have a 92% survival rate at 20 years (5). However, the vast majority of these studies were performed at high-volume centers, and national joint registries have continued to demonstrate an increased rate of early failure and decreased survivorship of UKA versus TKA(13).
Recently, robotic-assisted UKA has been introduced to improve the accuracy of implant positioning (4). As implant positioning including alignment and translation in the coronal and sagittal planes and implant sizing are critical for success after UKA, the addition of robotic-assistance theoretically can improve radiographic alignment and clinical outcomes.
Currently, the most common robotic guidance system used in UKA is the Robotic Arm Interactive Orthopedic System (RIO; MAKO Surgical; Ft. Lauderdale, FLA). The purposes of this investigation is to 1) retrospectively review the radiographic and clinical outcomes of medial UKA using conventional techniques performed at our institution and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice.
- Conditions
- Arthritis
- Being tested
- MAKO Robotic UKA
- Medical subject headings
- Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAKO Robotic UKADevice
Prospective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine
| Study group | Role | What they receive |
|---|---|---|
| Prospective Group- Robotic UKA Arm | Robotic UKA with the MAKO machine. Receives: Device: MAKO Robotic UKA | |
| Control- Fixed and Mobile UKA Arm | Patients who have received fixed or mobile bearing UKA | |
| Control-Total Knee Arthroplasty | Patients who have had cemented or cementless total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post Op EOS measurements for alignment
To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA). units of measurement will be inches.
Measured: 1 day- post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start12 Feb 2019
- Primary completion12 Dec 2020
- Study completion7 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for ArthritisStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 486 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447626
- Sponsor's protocol ID
- 201708096
- Status last verified
- May 2024
- First submitted
- 11 Dec 2017
- Last updated
- 9 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tsai TY, Dimitriou D, Liow MH, Rubash HE, Li G, Kwon YM. Three-Dimensional Imaging Analysis of Unicompartmental Knee Arthroplasty Evaluated in Standing Position: Component Alignment and In Vivo Articular Contact. J Arthroplasty. 2016 May;31(5):1096-101. doi: 10.1016/j.arth.2015.11.027. Epub 2015 Nov 30.
PubMed 26730450Bell SW, Anthony I, Jones B, MacLean A, Rowe P, Blyth M. Improved Accuracy of Component Positioning with Robotic-Assisted Unicompartmental Knee Arthroplasty: Data from a Prospective, Randomized Controlled Study. J Bone Joint Surg Am. 2016 Apr 20;98(8):627-35. doi: 10.2106/JBJS.15.00664.
PubMed 27098321Barrett WP, Scott RD. Revision of failed unicondylar unicompartmental knee arthroplasty. J Bone Joint Surg Am. 1987 Dec;69(9):1328-35.
PubMed 3440791Cheng T, Chen D, Zhu C, Pan X, Mao X, Guo Y, Zhang X. Fixed- versus mobile-bearing unicondylar knee arthroplasty: are failure modes different? Knee Surg Sports Traumatol Arthrosc. 2013 Nov;21(11):2433-41. doi: 10.1007/s00167-012-2208-y. Epub 2012 Sep 25.
PubMed 23007412Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. doi: 10.1302/0301-620x.80b6.8177.
PubMed 9853489Pandit H, Jenkins C, Gill HS, Smith G, Price AJ, Dodd CA, Murray DW. Unnecessary contraindications for mobile-bearing unicompartmental knee replacement. J Bone Joint Surg Br. 2011 May;93(5):622-8. doi: 10.1302/0301-620X.93B5.26214.
PubMed 21511927Nam D, Berend ME, Nunley RM, Della Valle CJ, Berend KR, Lombardi AV, Barrack RL. Residual Symptoms and Function After Unicompartmental and Total Knee Arthroplasty: Comparable to Normative Controls? J Arthroplasty. 2016 Oct;31(10):2161-6. doi: 10.1016/j.arth.2016.02.064. Epub 2016 Mar 10.
PubMed 27067170
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Market Study of Robotic-Arm Assisted Unicompartmental Knee Arthroplasty in Comparison to Traditional UKA (Fixed and Mobile Bearings)
- ClinicalTrials.gov ID
- NCT03447626
- Acronym / sponsor ID
- 201708096
- Conditions
- Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 486 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 12 Feb 2019 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 7 Apr 2024 (actual)
- First posted
- 27 Feb 2018 (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 purposes of this investigation is to 1) To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA)and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice and compare it to historical data on manual UKAs and TKAs.
Detailed description
Total knee arthroplasty (TKA) is known to have excellent long-term survivorship and clinical success in the management of degenerative joint disease, and remains the primary treatment for patients with bi- or tri-compartmental osteoarthritis. However, the patient population seeking knee arthroplasty is evolving, with patients being younger and more demanding on their prostheses (1). Recent investigations have highlighted that there remains a high incidence of residual symptoms including grinding/popping/clicking, swelling, and difficulties getting in and out of a car and chair, and 16% of patients remain "unsatisfied" following TKA (1).
Medial unicompartmental knee arthroplasty (UKA) remains a viable alternative to total knee arthroplasty in patients presenting with isolated, medial compartment osteoarthritis of the knee. Its use has increased in popularity in the United States, as the number of UKA performed over the last decade has increased by 30%(1). Proposed benefits of UKA include a smaller incision, less blood loss as well as shorter recovery time to functional level. Other benefits of UKAs include improved knee range of motion and better restoration of the knee kinematics (2, 5). These benefits are attributed to the less invasive nature of the procedure with preservation of the anterior and posterior cruciate ligaments, and minimal bony resections.
Unfortunately, historically the survival rate of UKA has been poor, with several reports demonstrating a survival rate of only 65-70% at 7-10 year follow-up (8, 9). These historically poor results have been attributed to instrumentation that was difficult to use, poor indications for the surgical procedure, and inadequate implant designs. More recent reports have shown 10-year survival rates ranging from 91% to 98% using both mobile-bearing and fixed-bearing UKA designs (7, 10-12). Mobile bearing UKA have a 92% survival rate at 20 years (5). However, the vast majority of these studies were performed at high-volume centers, and national joint registries have continued to demonstrate an increased rate of early failure and decreased survivorship of UKA versus TKA(13).
Recently, robotic-assisted UKA has been introduced to improve the accuracy of implant positioning (4). As implant positioning including alignment and translation in the coronal and sagittal planes and implant sizing are critical for success after UKA, the addition of robotic-assistance theoretically can improve radiographic alignment and clinical outcomes.
Currently, the most common robotic guidance system used in UKA is the Robotic Arm Interactive Orthopedic System (RIO; MAKO Surgical; Ft. Lauderdale, FLA). The purposes of this investigation is to 1) retrospectively review the radiographic and clinical outcomes of medial UKA using conventional techniques performed at our institution and 2) prospectively assess the learning curve, radiographic, and clinical outcomes of use of the RIO system as it is incorporated into our clinical practice.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prospective Group- Robotic UKA Arm | – | Device: MAKO Robotic UKARobotic UKA with the MAKO machine. |
| Control- Fixed and Mobile UKA Arm | – | –Patients who have received fixed or mobile bearing UKA |
| Control-Total Knee Arthroplasty | – | –Patients who have had cemented or cementless total knee arthroplasty |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Unilateral arthroplasty knee patients and total Knee arthroplasty patients
Key inclusion criteria (4 listed)
- All patients who receive a robotic arm assisted UKA using the RIO navigation system will be prospectively included. All patients who have received a medial fixed or mobile UKA performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed. Also, all TKAs from a pervious study (IRB 201308057) performed by surgeons in the Joint Preservation, Resurfacing, and Replacement Service at Washington University will be retrospectively reviewed as well.
Key exclusion criteria (10 listed)
- • Patient has a BMI < 40
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 |
|---|---|---|
| MAKO Robotic UKAProspective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine | Device | Prospective Group- Robotic UKA Arm |
Primary outcome
Post Op EOS measurements for alignment
Time frame: 1 day- post op
To determine if Robotic-arm assisted UKA (RA-UKA) allows for more accurate component placement than manual UKA (MI-UKA). units of measurement will be inches.
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 9 May 2024.
- Background: PubMed 26730450Tsai TY, Dimitriou D, Liow MH, Rubash HE, Li G, Kwon YM. Three-Dimensional Imaging Analysis of Unicompartmental Knee Arthroplasty Evaluated in Standing Position: Component Alignment and In Vivo Articular Contact. J Arthroplasty. 2016 May;31(5):1096-101. doi: 10.1016/j.arth.2015.11.027. Epub 2015 Nov 30.
- Background: PubMed 27098321Bell SW, Anthony I, Jones B, MacLean A, Rowe P, Blyth M. Improved Accuracy of Component Positioning with Robotic-Assisted Unicompartmental Knee Arthroplasty: Data from a Prospective, Randomized Controlled Study. J Bone Joint Surg Am. 2016 Apr 20;98(8):627-35. doi: 10.2106/JBJS.15.00664.
- Background: PubMed 3440791Barrett WP, Scott RD. Revision of failed unicondylar unicompartmental knee arthroplasty. J Bone Joint Surg Am. 1987 Dec;69(9):1328-35.
- Background: PubMed 23007412Cheng T, Chen D, Zhu C, Pan X, Mao X, Guo Y, Zhang X. Fixed- versus mobile-bearing unicondylar knee arthroplasty: are failure modes different? Knee Surg Sports Traumatol Arthrosc. 2013 Nov;21(11):2433-41. doi: 10.1007/s00167-012-2208-y. Epub 2012 Sep 25.
- Background: PubMed 9853489Murray DW, Goodfellow JW, O'Connor JJ. The Oxford medial unicompartmental arthroplasty: a ten-year survival study. J Bone Joint Surg Br. 1998 Nov;80(6):983-9. doi: 10.1302/0301-620x.80b6.8177.
- Background: PubMed 21511927Pandit H, Jenkins C, Gill HS, Smith G, Price AJ, Dodd CA, Murray DW. Unnecessary contraindications for mobile-bearing unicompartmental knee replacement. J Bone Joint Surg Br. 2011 May;93(5):622-8. doi: 10.1302/0301-620X.93B5.26214.
- Results publication: PubMed 27067170Nam D, Berend ME, Nunley RM, Della Valle CJ, Berend KR, Lombardi AV, Barrack RL. Residual Symptoms and Function After Unicompartmental and Total Knee Arthroplasty: Comparable to Normative Controls? J Arthroplasty. 2016 Oct;31(10):2161-6. doi: 10.1016/j.arth.2016.02.064. Epub 2016 Mar 10.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, run by Washington University School of Medicine 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 4 inclusion and 10 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 9 May 2024. 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?
Post Op EOS measurements for alignment (time frame: 1 day- post op). 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 NCT03447626, which also lists 7 linked publications.
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 9 May 2024.