Can robotic-assisted knee replacement with functional alignment improve outcomes vs. standard 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 multicenter, pragmatic randomized trial compares robot-assisted, functionally aligned total knee replacement (raTKA) to conventional manual total knee arthroplasty (mTKA) in adults with primary knee osteoarthritis. It uses a clearly defined surgical protocol and evaluates outcomes with patient-reported measures, 3D motion analysis, radiographs, and health-system data. Primary outcome is change in Forgotten Joint Score from before surgery to six months after, analyzed by intention-to-treat. Secondary outcomes include PROMs at 6 weeks, 6 and 12 months, radiographic alignment, intra-operative data, and biomechanical motion analysis. The study also examines safety, complications, and economic/operational impacts.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged \>18 years
* Primary knee OA
* Requiring TKA
* Suitable for either raTKA or mTKA
* Capable to provide written informed consent
* Capable and willing to complete outcome measures throughout study period

Exclusion Criteria:

* Inflammatory arthritis
* Significant symptomatic hip, ankle, or contralateral knee OA
* Prior TKA or major injury or major surgery on the index knee
* Neuromuscular gait disorders
* BMI \>45 kg/m2
* Coronal plane deformity \>15° varus/valgus on pre-op HKA radiograph
* Fixed flexion deformity greater than 15°
* Bone loss likely to require non-standard implants (e.g. stems, augments)
* Severe deformity or ligament insufficiency likely to require constraint
* Inability to comply with the required follow-up assessments or complete PROMs
* Contraindications to any aspect of the surgical technique

Where it's running

• Golden Jubilee University National Hospital
  Glasgow, Scotland, United Kingdom Recruiting

Study contacts

• Principal investigator: Christopher Gee, MSc, FRCS (Tr & Orth), MFSTEd — Golden Jubilee University National Hospital
• Study coordinator: Jon V Clarke, PhD, FRCS (Tr & Orth)
• Email: jon.clarke@gjnh.scot.nhs.uk
• Phone: +44 (0)141 951 5564

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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.