Total Knee ArthroplastyNCT07010809
Comparing Temperature in Burr vs Saw Cutting for Knee Arthroplasty
An observational study of Total Knee Arthroplasty and Total Knee Replacement, run by East Suffolk and North Essex NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
We will assess the temperatures achieved during bone cutting in total knee replacements, comparing burr and saw techniques. Our study involves recruiting 20 patients from East Suffolk and North Essex NHS Foundation Trust (Colchester site). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Total Knee Replacement
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 28 Jun 2024to 1 May 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients coming to Colchester hospital for a total knee arthroplasty.
Who may be able to join
- Symptomatic knee osteoarthritis
- 18+ years old
- Scheduled for TKA as part of standard of care
Who cannot join
- Distorted bone anatomy
- Previous knee surgery
- Diagnosed disease affected bone quality (e.g. Rheumatoid arthritis, Paget's disease, Osteomalacia)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Suffolk and North Essex NHS Foundation Trust
Colchester
About this study
Official title: Assessing Bone Thermal Damage in Knee Arthroplasty: Burring vs Sawing
We will assess the temperatures achieved during bone cutting in total knee replacements, comparing burr and saw techniques. Our study involves recruiting 20 patients from East Suffolk and North Essex NHS Foundation Trust (Colchester site). Patients will be recruited from the orthopaedic outpatient clinic, with 10 undergoing Robotic total knee arthroplasty (burr cutting) and 10 undergoing conventional total knee arthroplasty (saw cutting). Temperatures will be measured using a visual infrared thermometer placed outside the surgical field while a consultant surgeon performs the procedure. Importantly, these temperature recordings will have no impact on which treatment the patient received as the standard of care.
Read the detailed description
Patients will be recruited from elective orthopaedic outpatient clinics. All patients over the age of 18 with symptomatic osteoarthritis (OA), and due to undergo robotic assisted rTKA, with burr cutting, or cTKA, with saw cutting, will be considered for trial inclusion. Both devices are considered the standard of care for TKA.
This is an observational trial and the decision to undergo rTKA or cTKA is determined by patient factors, availability of equipment, and following consultation with the surgeon. The trial will not influence which patients undergo rTKA or cTKA.
10 patients undergoing cTKA and 10 patients undergoing rTKA will be recruited. During the procedure, a thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be setup 2 metres outside the sterile operating field to record temperatures reached during the distal femoral cut.
- Patients diagnosed with osteoarthritis follow a streamlined pathway to consult an orthopaedic surgeon. Initially, during the first clinic visit, the diagnosis is verified through both imaging and clinical examinations. After confirming the diagnosis, the patient is then scheduled for surgery, which could be either a robotic-assisted or a conventional total knee replacement, depending on their needs.
- Approximately 1-2 weeks prior to the surgery, patients attend a consent clinic. During this session, if they meet the inclusion criteria, they are provided with detailed study information and invited to participate. For those needing more time to decide, the option to take the consent form home is available. This gives them at least 1-2 weeks to consider their enrolment before the surgery.
- This study will not in any way impact the high standard of care provided to our patients. It is essential for researchers to ensure that enrolled patients have a comprehensive understanding of the trial procedures, the utilization of pseudo anonymized data, and contact addresses for any questions.
- The study includes no direct intervention- it is an observational study.
- A thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be used to monitor temperature at the bone interface from exposure of distal femur until the distal femoral cut has been completed.
- The camera will be positioned 2 meters away from the operative site out of the sterile operating field and will be operated by a trained members of staff who are members of the direct clinical care team.
- All measurements throughout the study will be captured with the same camera, calibrated to the ambient room temperature and humidity prior to use in accordance with the manufacturer's instructions.
- The camera will be connected to a password protected ESNEFT laptop computer, running the software application required to control and record from the thermal imaging camera (ThermaCAM Researcher Pro, version 2.8, Flir Systems Inc., Wilsonville, Oregon, USA, http://www.flir.com/).
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement
- Keywords
- Osteoarthritis
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Robotic Total Knee Arthroplasty | With burr cutting | |
| Conventional Total Knee Arthroplasty | With saw cutting |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty.
Temperature will be measured in degrees centigrade
Measured: During surgery
Secondary outcomes (1)
Duration of temperature above 47 degrees centigrade in burr and saw cutting groups.
Temperature will be measured in degrees centigrade.
Measured: During surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2025
- Study start28 Jun 2024
- Primary completionMay 2026 (estimated)
- Study completion1 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East Suffolk and North Essex NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07010809
- Sponsor's protocol ID
- 23/015
- Status last verified
- Feb 2026
- First submitted
- 30 May 2025
- Last updated
- 9 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Results of the temperatures recorded by the device will be published in peer-reviewed scientific journals and conference presentations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Bone Thermal Damage in Knee Arthroplasty: Burring vs Sawing
- ClinicalTrials.gov ID
- NCT07010809
- Acronym / sponsor ID
- 23/015
- Conditions
- Total Knee Arthroplasty, Total Knee Replacement
- Keywords
- Osteoarthritis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- East Suffolk and North Essex NHS Foundation TrustUniversity, hospital or other
- Study start
- 28 Jun 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- 1 May 2026 (estimated)
- First posted
- 8 Jun 2025 (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.
We will assess the temperatures achieved during bone cutting in total knee replacements, comparing burr and saw techniques. Our study involves recruiting 20 patients from East Suffolk and North Essex NHS Foundation Trust (Colchester site). Patients will be recruited from the orthopaedic outpatient clinic, with 10 undergoing Robotic total knee arthroplasty (burr cutting) and 10 undergoing conventional total knee arthroplasty (saw cutting). Temperatures will be measured using a visual infrared thermometer placed outside the surgical field while a consultant surgeon performs the procedure. Importantly, these temperature recordings will have no impact on which treatment the patient received as the standard of care.
Detailed description
Patients will be recruited from elective orthopaedic outpatient clinics. All patients over the age of 18 with symptomatic osteoarthritis (OA), and due to undergo robotic assisted rTKA, with burr cutting, or cTKA, with saw cutting, will be considered for trial inclusion. Both devices are considered the standard of care for TKA.
This is an observational trial and the decision to undergo rTKA or cTKA is determined by patient factors, availability of equipment, and following consultation with the surgeon. The trial will not influence which patients undergo rTKA or cTKA.
10 patients undergoing cTKA and 10 patients undergoing rTKA will be recruited. During the procedure, a thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be setup 2 metres outside the sterile operating field to record temperatures reached during the distal femoral cut.
- Patients diagnosed with osteoarthritis follow a streamlined pathway to consult an orthopaedic surgeon. Initially, during the first clinic visit, the diagnosis is verified through both imaging and clinical examinations. After confirming the diagnosis, the patient is then scheduled for surgery, which could be either a robotic-assisted or a conventional total knee replacement, depending on their needs.
- Approximately 1-2 weeks prior to the surgery, patients attend a consent clinic. During this session, if they meet the inclusion criteria, they are provided with detailed study information and invited to participate. For those needing more time to decide, the option to take the consent form home is available. This gives them at least 1-2 weeks to consider their enrolment before the surgery.
- This study will not in any way impact the high standard of care provided to our patients. It is essential for researchers to ensure that enrolled patients have a comprehensive understanding of the trial procedures, the utilization of pseudo anonymized data, and contact addresses for any questions.
- The study includes no direct intervention- it is an observational study.
- A thermal imaging camera (Thermovision A320, Flir Systems Inc., Wilsonville, Oregon, USA) will be used to monitor temperature at the bone interface from exposure of distal femur until the distal femoral cut has been completed.
- The camera will be positioned 2 meters away from the operative site out of the sterile operating field and will be operated by a trained members of staff who are members of the direct clinical care team.
- All measurements throughout the study will be captured with the same camera, calibrated to the ambient room temperature and humidity prior to use in accordance with the manufacturer's instructions.
- The camera will be connected to a password protected ESNEFT laptop computer, running the software application required to control and record from the thermal imaging camera (ThermaCAM Researcher Pro, version 2.8, Flir Systems Inc., Wilsonville, Oregon, USA, http://www.flir.com/).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic Total Knee Arthroplasty | – | –With burr cutting |
| Conventional Total Knee Arthroplasty | – | –With saw cutting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients coming to Colchester hospital for a total knee arthroplasty.
Key inclusion criteria (3 listed)
- Symptomatic knee osteoarthritis
- 18+ years old
- Scheduled for TKA as part of standard of care
Key exclusion criteria (3 listed)
- Distorted bone anatomy
- Previous knee surgery
- Diagnosed disease affected bone quality (e.g. Rheumatoid arthritis, Paget's disease, Osteomalacia)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty.
Time frame: During surgery
Temperature will be measured in degrees centigrade
1 secondary outcome
Duration of temperature above 47 degrees centigrade in burr and saw cutting groups.
Time frame: During surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Individual participant dataSharing planned: Yes. Results of the temperatures recorded by the device will be published in peer-reviewed scientific journals and conference presentations.
Related trials for Total Knee Arthroplasty
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Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
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Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Total Knee Arthroplasty and Total Knee Replacement, run by East Suffolk and North Essex NHS Foundation Trust 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 3 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 9 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty. (time frame: During surgery). 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 9 Feb 2026.