RecruitingNot ApplicableNCT05290818

Total Versus Robotic Assisted Unicompartmental Knee Replacement

Total Versus Robotic Assisted Unicompartmental Knee Replacement (TRAKER) for Medial Compartment Osteoarthritis: Randomised Controlled Trial


Sponsor

NHS Lothian

Enrollment

159 participants

Start Date

Aug 26, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 YearsMax Age: 75 Years

Inclusion Criteria7

  • 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

Exclusion Criteria10

  • 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,

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Interventions

DEVICEMAKO™ Partial Knee Arthroplasty

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

DEVICETriathlon (Stryker) Total Knee Arthroplasty

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


Locations(1)

Nicholas Clement

Edinburgh, Lothian, United Kingdom

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NCT05290818


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