Total Versus Robotic Assisted Unicompartmental Knee Replacement

NCT05290818 | Recruiting FDA Device

• 1 other identifier: AC19080
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare the functional outcomes of patients with end stage medial compartment OA of the knee undergoing a conventional mTKA to those undergoing rUKA and to assess the associated cost economics of such technology.

Conditions

Arthropathy of Knee; Osteo Arthritis Knee; Arthritis Knee

Keywords

Arthroplasty; Robotic; Knee; Total; Partial; Outcome; MAKO

Outcome Measures

Primary Outcomes (1)

• Oxford knee score

  Knee specific functional outcome measure. It consists of twelve questions assessed on a Likert scale with values from 0 to 4, to give a summative score. This is measured on a scale from 0 (worst) to 48 (best).

  Baseline to 6 months

Secondary Outcomes (8)

• Oxford knee score and Activity and Participation Questionnaire

  Baseline to 3, 6 and 12 months

• Forgotten Joint Score

  Baseline to 3, 6 and 12 months

• Patient satisfaction

  3, 6 and 12 months

• EQ-5D-3L

  Baseline to 3, 6 and 12 months

• Range of movement

  Baseline to 3, 6 and 12 months

Study Arms (2)

Manual Total Knee Arthroplasty

ACTIVE COMPARATOR

This group will receive a conventional manual Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert. The surgeon will then make bone cuts using a manual jig and a hand held saw to prepare the bone surfaces for the implant. A measured resection technique will be employed with a three degree tibial slope. The surgeon will use a conventional jig alignment technique for intramedullary referencing for the femur and extra medullary referencing for the tibia. Once the implant is in position the knee is then balanced by the "feel" though a range of movement and soft tissue releases will be performed as required to balance the knee in flexion and extension.

Device: Triathlon (Stryker) Total Knee Arthroplasty

Robotic Assisted Unicompartmental Knee Arthroplasty

EXPERIMENTAL

This group will receive the cemented Restoris MCK (Mako, Stryker) with a highly crossed linked (X3) polyethylene insert through a less invasive to the knee joint. Instead of using a manual jig and a hand held burr will be used to prepare the bone surfaces for the implant, the MAKO robotic arm will be used by the surgeon to cut the bone at the required alignment. The information from the CT scan will be used to create a 3D model of the patient's bony anatomy and will used to plan the positioning of the implant. Once the trackers are in place registration of the knee joint surface is performed. The specified bone cuts are then performed using the robotic arm, aiming to gap balance the knee through a full range of movement.

Device: MAKO™ Partial Knee Arthroplasty

Interventions

MAKO™ Partial Knee Arthroplasty DEVICE

The robotic-arm will be used to position a partial knee arthroplasty.

Also known as: Robotic-arm assisted partial knee arthroplasty

Robotic Assisted Unicompartmental Knee Arthroplasty

Triathlon (Stryker) Total Knee Arthroplasty DEVICE

Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.

Also known as: Total Knee Replacement

Manual Total Knee Arthroplasty

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Listed for elective primary TKA for end stage medial compartment osteoarthritis
• Intact anterior cruciate ligament
• Full thickness and good quality lateral cartilage
• Correctable intra-articular varus deformity and intact medial collateral ligament
• American Society of Anesthesiologists (ASA) grades 1 and 2
• Male or female, age 50 - 75 at the time of listing for surgery
• Suitable candidate for a cruciate retaining TKA (Triathlon prosthesis) and a UKA

You may not qualify if:

• Varus deformity of \> 20 degrees
• Fixed flexion of \>10 degrees
• Patient is unable to comply with the study protocol (incl. refusal for CT scan) or functional assessments
• Female participants who are pregnant, lactating or planning pregnancy during the course of the study
• Requires patella resurfacing or lateral compartment has significant OA
• Inability to understand the patient information for the study, provide written informed consent or answer study questionnaires for cognitive or language reasons
• Inflammatory disorder e.g. rheumatoid arthritis
• Symptomatic foot, hip or spine pathology
• Prior surgery (other than arthroscopy) or septic arthritis of the knee
• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study,

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Nicholas Clement

Edinburgh, Lothian, EH16 6SA, United Kingdom

RECRUITING

Related Publications (4)

• Robinson PG, Clement ND, Hamilton D, Blyth MJG, Haddad FS, Patton JT. A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. Bone Joint J. 2019 Jul;101-B(7):838-847. doi: 10.1302/0301-620X.101B7.BJJ-2018-1317.R1.

  PMID: 31256672 BACKGROUND

• Clement ND, Bell A, Simpson P, Macpherson G, Patton JT, Hamilton DF. Robotic-assisted unicompartmental knee arthroplasty has a greater early functional outcome when compared to manual total knee arthroplasty for isolated medial compartment arthritis. Bone Joint Res. 2020 May 16;9(1):15-22. doi: 10.1302/2046-3758.91.BJR-2019-0147.R1. eCollection 2020 Jan.

  PMID: 32435451 BACKGROUND

• Clement ND, Deehan DJ, Patton JT. Robot-assisted unicompartmental knee arthroplasty for patients with isolated medial compartment osteoarthritis is cost-effective: a markov decision analysis. Bone Joint J. 2019 Sep;101-B(9):1063-1070. doi: 10.1302/0301-620X.101B9.BJJ-2018-1658.R1.

  PMID: 31474149 BACKGROUND

• Clement ND; TRAKER Research Group; Scott CEH, Macpherson GJ, Simpson PM, Leitch G, Patton JT, Ahmed I, Amin AK, Gaston P, Goudie E, Goudie S, Macdonald DM, Martinson E, Moran M, Wade F. Total versus robotic-assisted unicompartmental knee replacement (TRAKER) for medial compartment osteorthritis: a randomized controlled trial. Bone Jt Open. 2025 Feb 10;6(2):164-177. doi: 10.1302/2633-1462.62.BJO-2024-0155.R1.

  PMID: 39923804 DERIVED

Related Links

• Home page of Edinburgh Orthopaedics

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Nicholas D Clement, MD, PhD

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicholas D Clement, MD, PhD

CONTACT

+44 131 536 1000; nick.clement@nhslothian.scot.nhs.uk

James T Patton, FRCS

CONTACT

+44 131 536 1000; Sam.Patton@nhslothian.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Randomised control Trial (1:2 ratio: 53 in the rUKA arm and 106 in the mTKA)

Study Record Dates

• First Submitted: February 16, 2022
• First Posted: March 22, 2022
• Study Start: August 26, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)