Blood LossTKANCT02108327
Blood Loss Between Surgical Blade and Unipolar Electrocautery in TKA
A study testing surgical blade and electrocautery in people with Blood Loss, run by Thammasat University at 1 site in Thailand.
Trial summary
Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Blood Loss
- What is being tested?
- surgical blade and electrocautery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2014to May 2015
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- age 50-85 years old
- ASA class 1-3
Who cannot join
- unable to perform spinal anaesthesia
- history of coagulation disorder
- renal impairment (CrCl <30 mL/min) or cirrhosis
- platelet count < 100,000 or abnormal coagulogram
- on pacemaker
- stop anti-platelet or anti-coagulogram less than 7 days
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Orthopaedic department, Faculty of medicine, Thammasat university
Klongluang, Changwat Pathum Thani, 066
About this study
Official title: Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty
Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).
- Conditions
- Blood Loss
- Being tested
- surgical blade, electrocautery
- Keywords
- Blood loss, total knee arthroplasty, hot knife, cold knife, unipolar electrocautery, surgical blade
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical bladeProcedure or surgery
Also called hot knife
Using surgical blade all the time of surgery
electrocauteryProcedure or surgery
Also called cold knife
Using electrocautery all the time except at skin incision
| Study group | Role | What they receive |
|---|---|---|
| surgical blade | Experimental | Not described Receives: Procedure: surgical blade |
| Unipolar electrocautery | Active comparator | Not described Receives: Procedure: electrocautery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss
- detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain
Measured: 48 hours
Secondary outcomes (4)
inflammation
determine inflammatory response with C-rective protein (CRP) at post-op 48 hours
Measured: 48 hours
Knee function
measured with WOMAC
Measured: 3 months
knee range of motion
Measured: 3 months
complication
detected with wound dehiscence, wound infection
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Blood LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02108327
- Sponsor's protocol ID
- orthoTU07
- Acronym
- TKA
- Status last verified
- May 2017
- First submitted
- 1 Apr 2014
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
PubMed 29968137
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Loss Between Surgical Blade and Unipolar Electrocautery in Primary Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02108327
- Acronym / sponsor ID
- TKA / orthoTU07
- Conditions
- Blood Loss
- Keywords
- Blood loss, total knee arthroplasty, hot knife, cold knife, unipolar electrocautery, surgical blade
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- Feb 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 9 Apr 2014 (estimated)
- 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.
Using of surgical blade may have less blood loss than unipolar electrocautery in Total Knee Arthroplasty (TKA).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgical blade | Experimental | Procedure: surgical blade |
| Unipolar electrocautery | Active comparator | Procedure: electrocautery |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- osteoarthritis of the knee who undergoing unilateral primary total knee arthroplasty
- age 50-85 years old
- ASA class 1-3
Key exclusion criteria (6 listed)
- unable to perform spinal anaesthesia
- history of coagulation disorder
- renal impairment (CrCl <30 mL/min) or cirrhosis
- platelet count < 100,000 or abnormal coagulogram
- on pacemaker
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 |
|---|---|---|
| surgical bladeAlso: hot knifeUsing surgical blade all the time of surgery | Procedure or surgery | surgical blade |
| electrocauteryAlso: cold knifeUsing electrocautery all the time except at skin incision | Procedure or surgery | Unipolar electrocautery |
Primary outcome
Blood loss
Time frame: 48 hours
- detected total blood loss from hemoglobin at 24,48 hours after surgery, maximum Hb drop and blood loss collected in radivac drain
4 secondary outcomes
inflammation
Time frame: 48 hours
Knee function
Time frame: 3 months
knee range of motion
Time frame: 3 months
complication
Time frame: 2 weeks
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 9 May 2017.
- Derived from this study: PubMed 29968137Tammachote N, Kanitnate S. Electric cautery does not reduce blood loss in primary total knee arthroplasty compared with scalpel only surgery a double-blinded randomized controlled trial. Int Orthop. 2018 Dec;42(12):2755-2760. doi: 10.1007/s00264-018-4048-y. Epub 2018 Jul 3.
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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?
A study testing surgical blade and electrocautery in people with Blood Loss, run by Thammasat University at 1 site in Thailand.
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 6 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 9 May 2017. 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 Thailand. 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?
Blood loss (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02108327, which also lists 1 linked publication.
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 May 2017.