Clinical trial NCT04192006: Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Arthritis
Surgery
Keywords: biomechanical
inflammation
mako robot
makoplasty
soft tissue injury
total knee arthroplasty
total knee replacement
thermal
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Stryker EU Operations BV
First posted: 2019-12-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Serum CRP level
timeFrame: 48 hours post-op
Secondary outcomes:
measure: C-reactive Protein (CRP)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Interleukin-1 beta (IL1 beta)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Interleukin-6 (IL6)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Tumour necrosis Factor alpha (TNFalpha),
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Creatine Kinase (CK)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Creatine Phosphokinase (CPK)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Full blood count (FBC)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Erythrocyte sedimentation rate (ESR)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Myoglobin (MG)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Lactate dehydrogenase (LDH)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: Urea and Electrolytes (U&Es)
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
measure: IL-6
timeFrame: 6 and 24 hours following surgery
measure: Interleukin-8 (IL-8)
timeFrame: 6 and 24 hours following surgery
measure: TNFalpha
timeFrame: 6 and 24 hours following surgery
measure: Thermal response to inflammation
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
measure: Soft tissue injury prior to implantation of femoral and tibial prostheses
timeFrame: 28 days post op
measure: Operating time
timeFrame: 28 days post op
measure: Time to discharge
timeFrame: 28 days post op
measure: Pain in knee
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days
measure: Analgesia requirements
timeFrame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
measure: Oxford knee score (OKS)
timeFrame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Short form health survey of 12 items (SF-12)
timeFrame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Knee injury and osteoarthritis outcome score (KOOS)
timeFrame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: Western Ontario and Mcmaster Universities Arthritis Index (WOMAC)
timeFrame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
measure: European Quality of Life questionnaire with 5 dimensions for adults (EQ-5D)
timeFrame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London Hospital NHS Foundation Trust
Study officials:
affiliation: UCL Hospitals NHS Foundation Trust
name: Fares S Haddad
role: STUDY_CHAIR
References: