Total Versus Robotic Assisted Unicompartmental Knee Replacement

Last updated: November 13, 2024
Sponsor: NHS Lothian
Overall Status: Active - Recruiting

Phase

N/A

Condition

Joint Injuries

Osteoarthritis

Treatment

Triathlon (Stryker) Total Knee Arthroplasty

MAKO™ Partial Knee Arthroplasty

Clinical Study ID

NCT05290818
AC19080
  • Ages 50-75
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Varus deformity of > 20 degrees

  • Fixed flexion of >10 degrees

  • Patient is unable to comply with the study protocol (incl. refusal for CT scan) orfunctional assessments

  • Female participants who are pregnant, lactating or planning pregnancy during thecourse of the study

  • Requires patella resurfacing or lateral compartment has significant OA

  • Inability to understand the patient information for the study, provide writteninformed 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,

Study Design

Total Participants: 159
Treatment Group(s): 2
Primary Treatment: Triathlon (Stryker) Total Knee Arthroplasty
Phase:
Study Start date:
August 26, 2024
Estimated Completion Date:
December 31, 2026

Study Description

Unicompartmental knee arthroplasty (UKA) is an accepted surgical alternative to total knee arthroplasty (TKA) for patients with isolated medial compartmental joint disease with the potential advantages of accelerated recovery, improved functional outcomes and retention of anatomical knee kinematics. However, some surgeons continue to favour TKA over UKA due to a lower revision rate. The higher revision rates associated with UKA are thought to be primarily due to component malpositioning and postoperative limb malalignment.

Robotic-arm assisted (r)UKA offers a greater level of precision of component positioning compared to manual UKA and more recently the survivorship of rUKA has been shown to be greater than manual UKA. Early functional outcomes following robotic UKA appear to be better than those observed after manual TKA. Therefore, the benefits of UKA could potentially be enjoyed by the patient without the increased risk of revision when compared to TKA for those with medical compartment disease.

The primary aim of this study is to compare the early knee specific functional outcome of rUKA with manually performed (m)TKA when performed for patients with medial compartment osteoarthritis of the knee.

A single centre randomised control trial will be carried out powered to the Oxford knee score.

Connect with a study center

  • Nicholas Clement

    Edinburgh, Lothian EH16 6SA
    United Kingdom

    Active - Recruiting

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