Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04192006
• Other study ID #: 17/0742
• Status: Completed
• Phase: N/A
• Start date: November 5, 2018
• Est. completion date: March 1, 2022

Study information

• Verified date: June 2023
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Surgery

Intervention

Device:
• Total Knee Arthroplasty
Surgical implantation of prosthetic knee using robotic-arm assist

Locations

Country	Name	City	State
United Kingdom	University College London Hospital NHS Foundation Trust	London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Stryker EU Operations BV

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum CRP level	Serum CRP level	48 hours post-op
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	IL-6	Local inflammatory response as assessed using intraarticular drain fluid	6 and 24 hours following surgery
Secondary	Interleukin-8 (IL-8)	Local inflammatory response as assessed using intraarticular drain fluid	6 and 24 hours following surgery
Secondary	TNFalpha	Local inflammatory response as assessed using intraarticular drain fluid	6 and 24 hours following surgery
Secondary	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.
Secondary	Soft tissue injury prior to implantation of femoral and tibial prostheses	macroscopic examination of the periarticular soft tissues	28 days post op
Secondary	Operating time	Operating time (minutes).	28 days post op
Secondary	Time to discharge	Time to discharge (hours).	28 days post op
Secondary	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
Secondary	Analgesia requirements	Analgesia requirements following surgery	6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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