NCT07010809

Brief 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). 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2024

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 8, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

1.8 years

First QC Date

May 30, 2025

Last Update Submit

February 5, 2026

Conditions

Keywords

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • The measure of temperature generated by burr and saw cutting devices during total knee arthroplasty.

    Temperature will be measured in degrees centigrade

    During surgery

Secondary Outcomes (1)

  • Duration of temperature above 47 degrees centigrade in burr and saw cutting groups.

    During surgery.

Study Arms (2)

Robotic Total Knee Arthroplasty

With burr cutting

Conventional Total Knee Arthroplasty

With saw cutting

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients coming to Colchester hospital for a total knee arthroplasty.

You may qualify if:

  • Symptomatic knee osteoarthritis
  • + years old
  • Scheduled for TKA as part of standard of care

You may not qualify if:

  • Distorted bone anatomy
  • Previous knee surgery
  • Diagnosed disease affected bone quality (e.g. Rheumatoid arthritis, Paget's disease, Osteomalacia)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Suffolk and North Essex NHS Foundation Trust

Colchester, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 30, 2025

First Posted

June 8, 2025

Study Start

June 28, 2024

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

February 9, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

Results of the temperatures recorded by the device will be published in peer-reviewed scientific journals and conference presentations.

Locations