Clinical trial NCT05736601: Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
Official title: Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Knee Osteoarthritis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2023-02-21
Enrollment: 95
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants 18 years and older who have chosen to partial knee surgery using the mako robotic system.

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.

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

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Patient reported Questionnaires for weekly VAS pain scores up weekly
timeFrame: 1 year
Secondary outcomes:
measure: Patient will track their Opioid Consumption use by filling out a chart weekly
timeFrame: 3 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University Medical School
state: Missouri
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.