Knee OsteoarthritisNCT05736601
Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- focus motion knee brace
- Type of treatment
- Medical device
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.
Who may be able to join
- Unilateral primary medial unicompartmental knee arthroplasty
- Age 18 years of age or older
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the FocusMotion platform
Who cannot join
- BMI > 40
- Personal history of DVT or PE
- Inflammatory arthritis
- Peripheral vascular disease
- Opioid use greater than 5 days per week
- Nonsteroidal anti-inflammatory allergy
Show all 10Show fewer
- Walking aid for musculoskeletal or neurologic issue other than operative joint
- Bilateral medial unicompartmental knee arthroplasty
- Patient with an active infection or suspected infection in the operative joint
- The absolute and relative contraindications stated in the FDA cleared labeling for the device
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University Medical School
St Louis, Missouri, 63110
About this study
To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.
Read the detailed description
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System
- Conditions
- Knee Osteoarthritis
- Being tested
- focus motion knee brace
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
focus motion knee braceDevice
knee brace that captures knee motion
| Study group | Role | What they receive |
|---|---|---|
| UKA MAKO | Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey Receives: Device: focus motion knee brace | |
| TKA MAKO | Control group-Already collected data on patient reported out comes using the FocusMotion app survey Receives: Device: focus motion knee brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient reported Questionnaires for weekly VAS pain scores up weekly
Patients will assess their weekly pain scores by filling out patient reported outcomes.
Measured: 1 year
Secondary outcomes (1)
Patient will track their Opioid Consumption use by filling out a chart weekly
Patients will report their weekly use by Opioid Consumption filling out a patient diary.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start27 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- 95 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Nordic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05736601
- Sponsor's protocol ID
- 202203201
- Status last verified
- Mar 2026
- First submitted
- 31 Jan 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Kayani B, Konan S, Tahmassebi J, Pietrzak JRT, Haddad FS. Robotic-arm assisted total knee arthroplasty is associated with improved early functional recovery and reduced time to hospital discharge compared with conventional jig-based total knee arthroplasty: a prospective cohort study. Bone Joint J. 2018 Jul;100-B(7):930-937. doi: 10.1302/0301-620X.100B7.BJJ-2017-1449.R1.
PubMed 29954217Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
PubMed 17403800Kazarian GS, Barrack TN, Okafor L, Barrack RL, Nunley RM, Lawrie CM. High Prevalence of Radiographic Outliers and Revisions with Unicompartmental Knee Arthroplasty. J Bone Joint Surg Am. 2020 Jul 1;102(13):1151-1159. doi: 10.2106/JBJS.19.01277.
PubMed 32618922Nam 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 27067170Lee BS, Cho HI, Bin SI, Kim JM, Jo BK. Femoral Component Varus Malposition is Associated with Tibial Aseptic Loosening After TKA. Clin Orthop Relat Res. 2018 Feb;476(2):400-407. doi: 10.1007/s11999.0000000000000012.
PubMed 29389790
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05736601
- Acronym / sponsor ID
- 202203201
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 95 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Stryker Nordic
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 21 Feb 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.
To determine if robotically-assisted UKA results in more consistent and improved component positioning and better patient reported outcome scores compared to manual TKA and MAKO TKA.
Detailed description
The purpose of this study is to determine the early clinical and radiographic outcomes of robotically-assisted medial unicompartmental knee arthroplasty (mUKA) with the MAKO surgical robot using the Restoris MCK Partial Implant System. The primary end point will be the mean weekly VAS pain score during the first four weeks postoperatively. The results of this study may be compared to those of previously studied cohorts of patients from this institution who underwent manual total knee arthroplasty (TKA) with the Triathlon Knee System as well as robotically-assisted total knee arthroplasty with the MAKO surgical robot using the Triathlon Knee System
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UKA MAKO | – | Device: focus motion knee braceProspective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey |
| TKA MAKO | – | Device: focus motion knee braceControl group-Already collected data on patient reported out comes using the FocusMotion app survey |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.
Key inclusion criteria (5 listed)
- Unilateral primary medial unicompartmental knee arthroplasty
- Age 18 years of age or older
- Willing to sign informed consent
- Willing to return for all follow-up visits
- Smartphone or tablet device capable of running the FocusMotion platform
Key exclusion criteria (10 listed)
- BMI > 40
- Personal history of DVT or PE
- Inflammatory arthritis
- Peripheral vascular disease
- Opioid use greater than 5 days per week
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 |
|---|---|---|
| focus motion knee braceknee brace that captures knee motion | Device | TKA MAKO, UKA MAKO |
Primary outcome
Patient reported Questionnaires for weekly VAS pain scores up weekly
Time frame: 1 year
Patients will assess their weekly pain scores by filling out patient reported outcomes.
1 secondary outcome
Patient will track their Opioid Consumption use by filling out a chart weekly
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Background: PubMed 29954217Kayani B, Konan S, Tahmassebi J, Pietrzak JRT, Haddad FS. Robotic-arm assisted total knee arthroplasty is associated with improved early functional recovery and reduced time to hospital discharge compared with conventional jig-based total knee arthroplasty: a prospective cohort study. Bone Joint J. 2018 Jul;100-B(7):930-937. doi: 10.1302/0301-620X.100B7.BJJ-2017-1449.R1.
- Results publication: PubMed 17403800Kurtz S, Ong K, Lau E, Mowat F, Halpern M. Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030. J Bone Joint Surg Am. 2007 Apr;89(4):780-5. doi: 10.2106/JBJS.F.00222.
- Results publication: PubMed 32618922Kazarian GS, Barrack TN, Okafor L, Barrack RL, Nunley RM, Lawrie CM. High Prevalence of Radiographic Outliers and Revisions with Unicompartmental Knee Arthroplasty. J Bone Joint Surg Am. 2020 Jul 1;102(13):1151-1159. doi: 10.2106/JBJS.19.01277.
- 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.
- Results publication: PubMed 29389790Lee BS, Cho HI, Bin SI, Kim JM, Jo BK. Femoral Component Varus Malposition is Associated with Tibial Aseptic Loosening After TKA. Clin Orthop Relat Res. 2018 Feb;476(2):400-407. doi: 10.1007/s11999.0000000000000012.
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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 Knee Osteoarthritis, 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 5 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient reported Questionnaires for weekly VAS pain scores up weekly (time frame: 1 year). 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 NCT05736601, which also lists 5 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 13 Mar 2026.