Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Knee Osteoarthritis Clinical Trial

Official title:

Early Outcomes of MAKO Medial Unicompartmental Knee Arthroplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05736601
• Other study ID #: 202203201
• Status: Recruiting
• Start date: December 27, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 95
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• focus motion knee brace
knee brace that captures knee motion

Locations

Country	Name	City	State
United States	Washington University Medical School	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Stryker Nordic

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. — View 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. — View 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.ar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	3 months