NCT04092153

Mako Functionally Aligned Total Knee Arthroplasty vs Mako Mechanically Aligned Total Knee Arthroplasty

A Prospective Randomised Control Trial Comparing Mako Robotic-arm Assisted Functionally Aligned Total Knee Arthroplasty Versus Mako Robotic-arm Assisted Mechanically Aligned Total Knee Arthroplasty

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University College, London · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates outcomes of robotic-arm assisted mechanically aligned total knee arthroplasty \[MA TKA\] versus robotic-arm assisted functionally aligned total knee arthroplasty \[FA TKA\]. Half the study will receive MA TKA and half will receive FA TKA.

Detailed description

Total knee arthroplasty \[TKA\] is an estabilshed treatment for symptomatic end-stage knee osteoarthritis, but there is a higher disatisfaction rate when compared to total hip arthroplasty. The exact aetiology of this is not clear but recent studies have shown one possible reason to be conventional TKA with mechanical alignment \[MA\] may force the knee into an unnatural position. This may lead to altered knee anatomy and kinematics that may compromise patient satisfaction. Total knee arthroplasty using functional alignment \[FA\] aims to restore the patient's prearthritic knee anatomy and native joint kinematics. Early clinical and functional outcome studies have reported promising outcomes in TKA with FA but results of longer term studies have not yet been published. There are very few prospective studies exploring clinical and radiological outcomes in MA versus FA for TKA. It is possible to improve on previous studies by recording a more comprehensive range of clinical and functional outcome measures, blinding patients and observers recording outcomes of interest, and using longer follow-up times. Robotic-arm assistance can be used to improve the accuracy of implant positioning. Clinical and functional outcomes should also be correlated to longer-term outcomes to better establish the "safe zone" for functional alignment. The findings of this study will enable an improved understanding of the clinical and functional benefits of FA compared to MA. These outcomes will improve our understanding of the optimal TKA alignment with possible improved outcomes; improved cost-effectiveness by reduced revisions and better patient satisfaction and function; and improved long-term implant survival. 100 patients will be enrolled in a 1:1 ratio between the two treatment groups. Trial patient will be allocated to either the MA TKA \['Control group'\] or to the FA TKA \['Investigation group'\]. Outcomes will be recorded at specific milestones.

Conditions

• Osteo Arthritis Knee
• Osteoarthritis
• Surgery

Interventions

Type	Name	Description
DEVICE	Total knee arthroplasy	Surgical implantation of prosthetic knee using robotic-arm assist

Timeline

• Start date: 2018-12-28
• Primary completion: 2025-02-06
• Completion: 2025-02-06
• First posted: 2019-09-17
• Last updated: 2025-07-09

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated device study