Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Knee Osteoarthritis, Arthritis, Surgery

Intervention / Treatment
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* Device: Total Knee Arthroplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has symptomatic knee osteoarthritis requiring primary TKA Patient and surgeon are in agreement that TKA is the most appropriate treatment Patient is fit for surgical intervention following review by surgeon and anaesthetist Patient is between 18-80 years of age at time of surgery Gender: male and female Patient must be capable of giving informed consent and agree to comply with the postoperative review program Patient must be a permanent resident in an area accessible to the study site Patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken Exclusion Criteria: Patient is not suitable for routine primary TKA e.g. patient has ligament deficiency that requires a constrained prosthesis Patient has inflammatory arthritis e.g. Rheumatoid arthritis Patient has local or systemic autoimmune disease Past medical history of cancer or chronic illness Patient has symptomatic arthritis of the contralateral knee

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional<br>Jig-based procedure | Device: Total Knee Arthroplasty<br>* Surgical implantation of prosthetic knee using robotic-arm assist<br>|
| Experimental: Robotic arm-assist<br>Mako robotic-arm assist based procedure | Device: Total Knee Arthroplasty<br>* Surgical implantation of prosthetic knee using robotic-arm assist<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum CRP level | Serum CRP level | 48 hours post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-reactive Protein (CRP) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Interleukin-1 beta (IL1 beta) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Interleukin-6 (IL6) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Tumour necrosis Factor alpha (TNFalpha), | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Creatine Kinase (CK) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Creatine Phosphokinase (CPK) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Full blood count (FBC) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Erythrocyte sedimentation rate (ESR) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Myoglobin (MG) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Lactate dehydrogenase (LDH) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| Urea and Electrolytes (U&Es) | Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA | 
| IL-6 | Local inflammatory response as assessed using intraarticular drain fluid | 6 and 24 hours following surgery | 
| Interleukin-8 (IL-8) | Local inflammatory response as assessed using intraarticular drain fluid | 6 and 24 hours following surgery | 
| TNFalpha | Local inflammatory response as assessed using intraarticular drain fluid | 6 and 24 hours following surgery | 
| Thermal response to inflammation | skin temperature over the operated knee joint preoperatively and postoperatively | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days. | 
| Soft tissue injury prior to implantation of femoral and tibial prostheses | macroscopic examination of the periarticular soft tissues | 28 days post op | 
| Operating time | Operating time (minutes). | 28 days post op | 
| Time to discharge | Time to discharge (hours). | 28 days post op | 
| Pain in knee | 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. | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days | 
| Analgesia requirements | Analgesia requirements following surgery | 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days. | 
| Oxford knee score (OKS) | Patient recorded outcome measure via questionnaire. 48 is best score and 0 worst score | Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Short form health survey of 12 items (SF-12) | 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. | Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Knee injury and osteoarthritis outcome score (KOOS) | 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% | Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| Western Ontario and Mcmaster Universities Arthritis Index (WOMAC) | Patient recorded outcome questionnaire evaluating pain, stiffness and disability in affected joint | Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 
| European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D) | Patient recorded outcome measure with 5 domains; score -1 to 1, with 1 being best score | Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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thermal, biomechanical, inflammation, mako robot, makoplasty, soft tissue injury, total knee arthroplasty, total knee replacement