NCT05736601

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Dec 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress56%
Dec 2022Dec 2028

Study Start

First participant enrolled

December 27, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 31, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2023

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

5 years

First QC Date

January 31, 2023

Last Update Submit

March 12, 2026

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Patient reported Questionnaires for weekly VAS pain scores up weekly

    Patients will assess their weekly pain scores by filling out patient reported outcomes.

    1 year

Secondary Outcomes (1)

  • Patient will track their Opioid Consumption use by filling out a chart weekly

    3 months

Study Arms (2)

UKA MAKO

Prospective group- Patient Reported Outcomes (PROs) will be assessed using the FocusMotion app survey

Device: focus motion knee brace

TKA MAKO

Control group-Already collected data on patient reported out comes using the FocusMotion app survey

Device: focus motion knee brace

Interventions

focus motion knee braceDEVICE

knee brace that captures knee motion

TKA MAKOUKA MAKO

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.

You may qualify if:

  • A. Unilateral primary medial unicompartmental knee arthroplasty
  • B. Age 18 years of age or older
  • C. Willing to sign informed consent
  • D. Willing to return for all follow-up visits
  • E. Smartphone or tablet device capable of running the FocusMotion platform

You may not qualify if:

  • A. BMI \> 40
  • B. Personal history of DVT or PE
  • C. Inflammatory arthritis
  • D. Peripheral vascular disease
  • E. Opioid use greater than 5 days per week
  • F. Nonsteroidal anti-inflammatory allergy
  • G. Walking aid for musculoskeletal or neurologic issue other than operative joint
  • H. Bilateral medial unicompartmental knee arthroplasty
  • I. Patient with an active infection or suspected infection in the operative joint
  • J. The absolute and relative contraindications stated in the FDA cleared labeling for the device

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University Medical School

St Louis, Missouri, 63110, United States

Location

Related Publications (5)

  • 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.

    PMID: 29954217BACKGROUND

  • Kurtz 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.

    PMID: 17403800RESULT

  • Kazarian 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.

    PMID: 32618922RESULT

  • Nam 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.

    PMID: 27067170RESULT

  • Lee 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.

    PMID: 29389790RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2023

First Posted

February 21, 2023

Study Start

December 27, 2022

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Last Updated

March 13, 2026

Record last verified: 2026-03

Locations

US(1)