UKA Manual Versus UKA MAKO Robotic

NCT03447626 | Completed

• 1 other identifier: 201708096
• Study Type: observational
• Target: 486
• Locations: 1 country
• Sites: 1

Brief 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 practice and compare it to historical data on manual UKAs and TKAs.

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  1 day- post op

Study Arms (3)

Prospective Group- Robotic UKA Arm

Robotic UKA with the MAKO machine.

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

Interventions

MAKO Robotic UKA DEVICE

Prospective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine

Prospective Group- Robotic UKA Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Unilateral arthroplasty knee patients and total Knee arthroplasty patients

You may qualify if:

• 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

You may not qualify if:

• 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.
• Blood supply limitations
• Collateral ligament insufficiency.
• Patients with prior HTOs or Unis.
• Patients requiring bilateral knee arthroplasty.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Related Publications (7)

• 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.

  PMID: 26730450 BACKGROUND

• Bell 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.

  PMID: 27098321 BACKGROUND

• Barrett WP, Scott RD. Revision of failed unicondylar unicompartmental knee arthroplasty. J Bone Joint Surg Am. 1987 Dec;69(9):1328-35.

  PMID: 3440791 BACKGROUND

• Cheng 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.

  PMID: 23007412 BACKGROUND

• Murray 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.

  PMID: 9853489 BACKGROUND

• Pandit 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.

  PMID: 21511927 BACKGROUND

• 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: 27067170 RESULT

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Design

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

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: February 27, 2018
• Study Start: February 12, 2019
• Primary Completion: December 12, 2020
• Study Completion: April 7, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Locations

US (1)