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Total Versus Robotic Assisted Unicompartmental Knee Replacement

Sponsor: NHS Lothian

NCT ID: NCT05290818

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
MAKO™ Partial Knee Arthroplasty (device), Triathlon (Stryker) Total Knee Arthroplasty (device)
How long the study runs
Study runs about 40 months (dates as stated)
About the drug or intervention
MAKO™ Partial Knee Arthroplasty — device: The robotic-arm will be used to position a partial knee arthroplasty. · Triathlon (Stryker) Total Knee Arthroplasty — device: Triathlon (Stryker) TKA with a cruciate retaining polyethylene insert.
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
50 Years to 75 Years
Who
All
Number of participants
159
Started
2024-08-26
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for osteo arthritis knee
  • • NA - 159 participants
  • • 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

Who can take part?

  • • Ages 50 Years to 75 Years
  • • Diagnosed with osteo arthritis knee

Where?

  • • Edinburgh - Nicholas Clement

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Osteo Arthritis KneeArthritis KneeArthropathy of Knee

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 50 Years - 75 Years
  • Who can join: All genders

What the study is looking for

  • ✓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

Who cannot take part

  • ✗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
See the full criteria
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 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) 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,

Where Is This Study? (1 UK site)

Nicholas Clement

Edinburgh EH16 6SA, United Kingdom

Recruiting
Site contact (verified)

How to Get in Touch

Nicholas D Clement, MD, PhD

Sponsor contact

CONTACT

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

James T Patton, FRCS

Sponsor contact

CONTACT

+44 131 536 1000 Sam.Patton@nhslothian.scot.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-09