Comparing total knee replacement to robotic-assisted partial knee replacement

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This research aims to compare the functional outcomes of patients with end-stage medial compartment osteoarthritis of the knee undergoing conventional total knee arthroplasty (TKA) versus those receiving robotic-assisted unicompartmental knee arthroplasty (UKA). The study will assess the precision of component positioning and the associated recovery benefits of robotic assistance compared to manual techniques. A single-center randomized control trial will be conducted, focusing on early knee-specific functional outcomes measured by the Oxford knee score. The study also aims to evaluate the cost-effectiveness of robotic technology in knee replacement procedures.

Why it matters

Who can join: the full rules

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 it's running

• Nicholas Clement
  Edinburgh, Lothian, United Kingdom Recruiting

Study contacts

• Principal investigator: Nicholas D Clement, MD, PhD — NHS Lothian
• Study coordinator: Nicholas D Clement, MD, PhD
• Email: nick.clement@nhslothian.scot.nhs.uk
• Phone: +44 131 536 1000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.