RCT: Inflammatory response CO TKA vs Mako TKA
Research type
Research Study
Full title
A prospective randomised controlled trial comparing the biochemical, thermal, and macroscopic soft tissue outcomes in conventional jig-based total knee arthroplasty versus Mako robotic-arm assisted total knee arthroplasty
IRAS ID
241393
Contact name
Fares Haddad
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
3 years, 6 months, 1 days
Research summary
Total knee arthroplasty involves removing parts of the knee joint that have become worn out and arthritic and replacing these with artificial implants. The positioning and alignment of these artificial implants is important because they influence clinical function and implant survival. Advances in surgical technology have led to the development of computer software and robotic machines to improve implant positioning and alignment in total knee arthroplasty.
The Mako robotic machine uses x-rays and CT scan of the patient’s knee joint to calculate the amount of bone resection required and plan optimal implant position. A robotic arm then guides the surgeon during surgery to ensure that only the specified amount of bone is resected and implants are positioned correctly. In conventional total knee arthroplasty, the surgeon uses a CT scan to plan the operation and uses alignment jigs to guide bone resection and implant positioning,
The objective of this study is to compare the extent of muscle damage and bone trauma in patients undergoing conventional total knee arthroplasty versus those receiving robotic-arm assisted total knee arthroplasty.
The study will include 30 patients with arthritis affecting the knee joint undergoing total knee arthroplasty at University College Hospital. Following informed consent, patients will be randomised into one of the two treatment groups and undergo total knee arthroplasty using either the Mako robot (Investigation group) or conventional technique (control group). All patients will receive the same rehabilitation programme following surgery. Temperature recordings of the knee joint, blood tests, drain fluid, and visual examination of the knee joint will be used to assess bone trauma and soft tissue injury. Clinical follow up will be for 2 years after surgery.
This study will enable us to determine which of the two surgical techniques in total knee arthroplasty enables better clinical outcomes, faster rehabilitation, and reduced complications.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0926
Date of REC Opinion
30 May 2018
REC opinion
Favourable Opinion