Actively Recruiting

Phase Not Applicable
Age: 50Years - 75Years
All Genders
ID05290818

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

Led by NHS Lothian · Updated on 2026-02-06

159

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research compares functional outcomes and costs between two types of knee replacement surgeries for patients with end-stage medial compartment osteoarthritis of the knee. It focuses on manual total knee arthroplasty (mTKA) versus robotic-assisted unicompartmental knee arthroplasty (rUKA). The study aims to evaluate whether the newer robotic-assisted technique improves early knee function while addressing concerns about revision rates seen with traditional unicompartmental procedures. Participants will receive either a conventional manual total knee replacement using a Triathlon (Stryker) implant or a robotic-assisted partial knee replacement with the MAKO system. The manual group undergoes bone cuts using traditional tools, while the robotic group uses a robotic arm guided by a CT-based 3D model for precise bone preparation and implant placement. Both surgeries aim to balance the knee through a range of motion. During the study, participants will be assessed on knee function and satisfaction using measures like the Oxford knee score, Forgotten Joint Score, range of motion, and patient questionnaires at multiple time points up to 12 months. Researchers will also monitor cost-effectiveness and knee stability. The trial is randomized and double-blinded, with follow-up evaluations extending to one year after surgery.

CONDITIONS

Brief Title

Total Versus Robotic Assisted Unicompartmental Knee Replacement

Who Can Participate

Age: 50Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Listed for elective primary total knee arthroplasty 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 to 75 at the time of listing for surgery
  • Suitable candidate for a cruciate retaining total knee arthroplasty (Triathlon prosthesis) and a unicompartmental knee arthroplasty
Not Eligible

You will not qualify if you...

  • Varus deformity greater than 20 degrees
  • Fixed flexion greater than 10 degrees
  • Unable to comply with the study protocol including refusal for CT scan or functional assessments
  • Female participants who are pregnant, lactating or planning pregnancy during the study
  • Requires patella resurfacing or has significant osteoarthritis of the lateral compartment
  • Inability to understand study information, provide informed consent, or answer questionnaires due to cognitive or language reasons
  • Inflammatory disorders such as rheumatoid arthritis
  • Symptomatic foot, hip, or spine pathology
  • Prior knee surgery other than arthroscopy or septic arthritis
  • Any other significant disease or disorder that may increase risk due to study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Surgery and Immediate Post-operative Care

Duration - Day of surgery and immediate recovery period

Participants undergo either robotic-assisted unicompartmental knee arthroplasty or manual total knee arthroplasty surgery followed by immediate post-operative care.

1 surgical visit and immediate post-operative care

Post-operative Follow-up

Duration - Up to 12 months

Participants are followed to assess knee function, patient satisfaction, and other outcomes after surgery.

Visits at baseline, 3, 6, and 12 months

Trial Site Locations

Total: 1 location

1

Nicholas Clement

Edinburgh, Lothian, United Kingdom, EH16 6SA

Actively Recruiting

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Research Team

N

Nicholas D Clement, MD, PhD

J

James T Patton, FRCS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported.

P G Robinson, N D Clement, D Hamilton...

https://pubmed.ncbi.nlm.nih.gov/31256672

Robotic-assisted unicompartmental knee arthroplasty has a greater early functional outcome when compared to manual total knee arthroplasty for isolated medial compartment arthritis.

N D Clement, A Bell, P Simpson...

https://pubmed.ncbi.nlm.nih.gov/32435451

Robot-assisted unicompartmental knee arthroplasty for patients with isolated medial compartment osteoarthritis is cost-effective: a markov decision analysis.

Nick D Clement, David J Deehan, James T Patton

https://pubmed.ncbi.nlm.nih.gov/31474149

Total versus robotic-assisted unicompartmental knee replacement (TRAKER) for medial compartment osteorthritis: a randomized controlled trial.

Nick D Clement, TRAKER Research Group, Chloe E H Scott...

https://pubmed.ncbi.nlm.nih.gov/39923804