University College London Hospital NHS Foundation Trust
London, NW1 2PG, United Kingdom
NCT Number: NCT04192006
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 patient's 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 patient's 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 patient's 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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
London, NW1 2PG, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Surgical implantation of prosthetic knee using robotic-arm assist
Time frame: 48 hours post-op
Serum CRP level
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Time frame: 6 and 24 hours following surgery
Local inflammatory response as assessed using intraarticular drain fluid
Time frame: 6 and 24 hours following surgery
Local inflammatory response as assessed using intraarticular drain fluid
Time frame: 6 and 24 hours following surgery
Local inflammatory response as assessed using intraarticular drain fluid
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
skin temperature over the operated knee joint preoperatively and postoperatively
Time frame: 28 days post op
macroscopic examination of the periarticular soft tissues
Time frame: 28 days post op
Operating time (minutes).
Time frame: 28 days post op
Time to discharge (hours).
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days
Subjective score. Pain as assessed using the Visual analogue score (VAS) following surgery. Patient uses line delineated at left hand end with '0' and '10' at the right hand end. 0= no pain; 10 = the most pain. Patient indicates where they feel their pain fits onto this score.
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
Analgesia requirements following surgery
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure. Questions concerning attitudes to physical and mental heath with 12 questions combined to give overall norm-based values; higher score better, lower score worse.
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure via questionnaire. 6 separate domains including pain, stiffness, quality of life, symptoms, and function; each domain creates percentage with overall cumulative percentage achieved; best score 100%
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score
University College, London
Other
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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