RCT: Mako FA TKA vs Mako MA TKA
Research type
Research Study
Full title
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
IRAS ID
241404
Contact name
Fares Haddad
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Total knee arthroplasty (TKA) involves removing parts of the knee joint that have become worn out and arthritic and replacing these with artificial implants. The positions of these implants and overall alignment of the leg are important because they influence clinical outcomes and implant survivorship. The Mako robot uses three-dimensional images of the patient’s knee joint to help the surgeon to improve the accuracy of implant positioning during surgery.
The aim of this study is to determine if patient recovery is better with functionally aligned Mako robotic-assisted total knee arthroplasty (FA TKA) or mechanically aligned Mako robotic-assisted total knee arthroplasty (MA TKA).
In MA TKA, bone is prepared and implants positioned to ensure that that the overall alignment of the
leg is in neutral. In FA TKA, the bone is prepared and implants positioned to restore the natural alignment of
the patient’s leg. Both of these surgical techniques provide excellent outcomes in TKA but it is not known
which of the two techniques is better for patient recovery.The study will include 100 patients with arthritis affecting the knee joint undergoing TKA at University College Hospital. Following informed consent, patients will be randomised into one of the two treatment groups and undergo Mako robotic-arm assisted TKA using either FA (Investigation group) or MA (control group). All patients will receive the same rehabilitation programme following surgery. Clinical progress will be recorded at regular intervals for two years after surgery. All patients will also undergo gait analysis and radiosteriometric analysis (RSA) to assess implant stability and migration between the two treatment groups. This involves the insertion of inert tantalum beads around the implants and serial radiographs to asses implant migration.
This study will enable us to determine which of the two surgical alignments in TKA enables improved better clinical outcomes, faster functional recovery, and longer implant survival.
REC name
London - Surrey Research Ethics Committee
REC reference
18/LO/0793
Date of REC Opinion
18 Jun 2018
REC opinion
Further Information Favourable Opinion