Comparing two types of robotic-assisted knee replacement surgeries

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 study evaluates the outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty (MA TKA) versus functionally aligned total knee arthroplasty (FA TKA). Participants will be randomly assigned to receive either MA TKA or FA TKA, with the aim of restoring the patient's natural knee anatomy and improving satisfaction rates. The study will collect a comprehensive range of clinical and functional outcome measures, with a focus on long-term results to better understand the benefits of functional alignment. By utilizing robotic assistance, the study aims to enhance the accuracy of implant positioning and correlate outcomes with longer-term results.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient has symptomatic knee osteoarthritis requiring primary TKA
* Patient and surgeon are in agreement that TKA is the most appropriate treatment
* Patient is fit for surgical intervention following review by surgeon and anaesthetist
* Patient is between 18-80 years of age at time of surgery
* Gender: male and female
* Patient must be capable of giving informed consent and agree to comply with the postoperative review program
* Patient must be a permanent resident in an area accessible to the study site
* Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken

Exclusion Criteria:

* Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis
* Patient has bone loss that requires augmentation
* Patient is not medically fit for surgical intervention
* Patient requires revision surgery following previously failed correctional osteotomy or ipsilateral TKA
* Patient is immobile or has another neurological condition affecting musculoskeletal function
* Patient is less than 18 years of age or greater than 80 years of age
* Patient is already enrolled on another concurrent clinical trial
* Patient is unable or unwilling to sign the informed consent form specific to this study
* Patient is unable to attend the follow-up programme
* Patient is non-resident in local area or expected to leave the catchment area postoperatively

Where it's running

• University College London Hospital NHS Foundation Trust
  London, United Kingdom Recruiting

Study contacts

• Study coordinator: Jenni Tahmassebi
• Email: jenni.tahmassebi1@nhs.net
• Phone: 02034479413

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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.