Knee OsteoarthritisNCT04192006
Inflammatory Response Conventional Total Knee Replacement Versus Mako Total Knee Replacement
A study testing Total Knee Arthroplasty in people with Knee Osteoarthritis and Arthritis, run by University College, London at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Arthritis, Surgery
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Nov 2018to 1 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College London Hospital NHS Foundation Trust
London, NW1 2PG
About this study
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
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.
Read more
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.
- Conditions
- Knee Osteoarthritis, Arthritis, Surgery
- Being tested
- Total Knee Arthroplasty
- Keywords
- biomechanical, inflammation, mako robot, makoplasty, soft tissue injury, total knee arthroplasty, total knee replacement, thermal
- Medical subject headings
- Osteoarthritis, Knee, Arthritis, Inflammation, Soft Tissue Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyDevice
Surgical implantation of prosthetic knee using robotic-arm assist
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Active comparator | Jig-based procedure Receives: Device: Total Knee Arthroplasty |
| Robotic arm-assist | Experimental | Mako robotic-arm assist based procedure Receives: Device: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum CRP level
Serum CRP level
Measured: 48 hours post-op
Secondary outcomes (25)
C-reactive Protein (CRP)
Systemic inflammation as assessed by the serial measurement of serum inflammatory cytokines and enzyme markers of soft tissue injury
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 6 and 24 hours following surgery
Interleukin-8 (IL-8)
Local inflammatory response as assessed using intraarticular drain fluid
Measured: 6 and 24 hours following surgery
TNFalpha
Local inflammatory response as assessed using intraarticular drain fluid
Measured: 6 and 24 hours following surgery
Thermal response to inflammation
skin temperature over the operated knee joint preoperatively and postoperatively
Measured: 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
Measured: 28 days post op
Operating time
Operating time (minutes).
Measured: 28 days post op
Time to discharge
Time to discharge (hours).
Measured: 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.
Measured: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days
Analgesia requirements
Analgesia requirements following surgery
Measured: 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
Measured: 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.
Measured: 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%
Measured: 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
Measured: 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
Measured: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start5 Nov 2018
- Primary completion31 Dec 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker EU Operations BV
- Responsible party
- Sponsor
- Investigators
- Fares S Haddad, Study chair, UCL Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04192006
- Sponsor's protocol ID
- 17/0742
- Status last verified
- Jun 2023
- First submitted
- 6 Dec 2019
- Last updated
- 28 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No plan
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04192006
- Acronym / sponsor ID
- 17/0742
- Conditions
- Knee Osteoarthritis, Arthritis, Surgery
- Keywords
- biomechanical, inflammation, mako robot, makoplasty, soft tissue injury, total knee arthroplasty, total knee replacement, thermal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Stryker EU Operations BV
- Study start
- 5 Nov 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Active comparator | Device: Total Knee ArthroplastyJig-based procedure |
| Robotic arm-assist | Experimental | Device: Total Knee ArthroplastyMako robotic-arm assist based procedure |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total Knee ArthroplastySurgical implantation of prosthetic knee using robotic-arm assist | Device | Conventional, Robotic arm-assist |
Primary outcome
Serum CRP level
Time frame: 48 hours post-op
Serum CRP level
25 secondary outcomes
C-reactive Protein (CRP)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Interleukin-1 beta (IL1 beta)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Interleukin-6 (IL6)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Tumour necrosis Factor alpha (TNFalpha),
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Creatine Kinase (CK)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Creatine Phosphokinase (CPK)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Full blood count (FBC)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Erythrocyte sedimentation rate (ESR)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Myoglobin (MG)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Lactate dehydrogenase (LDH)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
Urea and Electrolytes (U&Es)
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days following TKA
IL-6
Time frame: 6 and 24 hours following surgery
Interleukin-8 (IL-8)
Time frame: 6 and 24 hours following surgery
TNFalpha
Time frame: 6 and 24 hours following surgery
Thermal response to inflammation
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
Soft tissue injury prior to implantation of femoral and tibial prostheses
Time frame: 28 days post op
Operating time
Time frame: 28 days post op
Time to discharge
Time frame: 28 days post op
Pain in knee
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days
Analgesia requirements
Time frame: 6 hours, 1 day, 2 days, 3 days, 7 days, and 28 days.
Oxford knee score (OKS)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Pre-op; 4 weeks post-op; 6 months post-op; 1 year post-op; 2 years post-op
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2023.
- Individual participant dataSharing planned: No. No plan
Related trials for Knee Osteoarthritis
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
RecruitingPhase 2
Genicular Artery Embolization for Reducing Pain in Medically Refractory Symptomatic Knee Osteoarthritis
Knee Osteoarthritis, Knee Osteoarthritis (Knee OA)
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
The Effect of Different Exercise Training Programs on Muscle Oxygenation in Individuals With Knee Osteoarthritis
Osteoarthritis of Knee
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fares S Haddad study chair
UCL Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total Knee Arthroplasty in people with Knee Osteoarthritis and Arthritis, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum CRP level (time frame: 48 hours post-op). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2023.