Ignite Creation Date:
2024-05-06 @ 2:02 PM
Last Modification Date:
2024-10-26 @ 1:23 PM
Study NCT ID:
NCT04192006
Status:
COMPLETED
Last Update Posted:
2023-06-28
First Post:
2019-12-06
Brief Title:
Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement
Sponsor:
University College London
Organization:
University College London
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Total knee Arthroplasty TKA is a highly effective treatment for knee osteoarthritis Mid- to long-term follow-up studies have shown good clinical outcomes following TKA despite these results there is a high incidence of patient dissatisfaction 20 of patients reporting dissatisfaction in otherwise uncomplicated procedures
One reason for early dissatisfaction may be the trauma of surgery may lead to localised and systemic inflammatory responses that impair postoperative clinical recovery this in turn influences long-term functional outcomes Surgical techniques that limit the insult of surgery and help to restore the patients native knee anatomy and kinematics may help to improve clinical outcomes functional recovery and patient satisfaction
The technical objectives of surgery are to restore limb alignment preserve the joint line balance flexion and extension gaps and maintain the normal Q angle for optimal patella tracking Compromise to the periarticular soft tissue structures may compromise postoperative clinical and functional recovery reduce stability and decrease implant survivorship In conventional jig-based CO TKA bone cuts are most commonly performed using measured resection or gap balancing The manual error associated with inadvertent soft tissue release during preparation for implantation or tissue damage from the saw blades is an accepted part of the procedure
The evolution of surgical technology has led to the development of robotic-arm assisted TKA which uses three dimensional images of the patients native knee anatomy to guide bone resection and optimise implant positioning The second-generation RIO Robotic Arm Interactive Orthopaedic system Mako surgical uses preoperative computerised tomography scans to build a computer-aided design CAD model of the patients knee joint The Mako robotic software processes this information to calculate the volume of bone requiring resection and creates a three-dimensional haptic window for the RIO robotic arm to resect
In short the robotic technology in TKA allows execution of the preoperative surgical plan without undue soft tissue release inadvertent trauma from power tools and minimal trauma to bone surfaces Conceptually this Mako TKA should have reduced soft tissue trauma and inflammatory response as assessed with inflammatory cytokines compared to CO TKA
The overall aim of this single centre prospective randomised controlled trial is to determine differences in the inflammatory response between CO TKA and Mako TKA
A comprehensive range of local and systemic biochemical markers thermal response and macroscopic soft tissue injury outcomes between the two groups will be recorded and correlated to clinical and functional outcomes over 2-year postoperative Patients undergoing CO TKA will form the control group and those undergoing Mako TKA will form the investigation group
One reason for early dissatisfaction may be the trauma of surgery may lead to localised and systemic inflammatory responses that impair postoperative clinical recovery this in turn influences long-term functional outcomes Surgical techniques that limit the insult of surgery and help to restore the patients native knee anatomy and kinematics may help to improve clinical outcomes functional recovery and patient satisfaction
The technical objectives of surgery are to restore limb alignment preserve the joint line balance flexion and extension gaps and maintain the normal Q angle for optimal patella tracking Compromise to the periarticular soft tissue structures may compromise postoperative clinical and functional recovery reduce stability and decrease implant survivorship In conventional jig-based CO TKA bone cuts are most commonly performed using measured resection or gap balancing The manual error associated with inadvertent soft tissue release during preparation for implantation or tissue damage from the saw blades is an accepted part of the procedure
The evolution of surgical technology has led to the development of robotic-arm assisted TKA which uses three dimensional images of the patients native knee anatomy to guide bone resection and optimise implant positioning The second-generation RIO Robotic Arm Interactive Orthopaedic system Mako surgical uses preoperative computerised tomography scans to build a computer-aided design CAD model of the patients knee joint The Mako robotic software processes this information to calculate the volume of bone requiring resection and creates a three-dimensional haptic window for the RIO robotic arm to resect
In short the robotic technology in TKA allows execution of the preoperative surgical plan without undue soft tissue release inadvertent trauma from power tools and minimal trauma to bone surfaces Conceptually this Mako TKA should have reduced soft tissue trauma and inflammatory response as assessed with inflammatory cytokines compared to CO TKA
The overall aim of this single centre prospective randomised controlled trial is to determine differences in the inflammatory response between CO TKA and Mako TKA
A comprehensive range of local and systemic biochemical markers thermal response and macroscopic soft tissue injury outcomes between the two groups will be recorded and correlated to clinical and functional outcomes over 2-year postoperative Patients undergoing CO TKA will form the control group and those undergoing Mako TKA will form the investigation group
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None