Osteoarthritis, KneePhase 3NCT06239038
Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty
A Phase 3 study testing total knee arthroplasty in people with Osteoarthritis, Knee, run by Police General Hospital, Thailand at 1 site in Thailand.
Trial summary
Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. Read more about this study
- Who is it for?
- Ages 58 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- total knee arthroplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteThailand
- Study dates
- 11 Oct 2021to 29 Feb 2024
- Phase
- Phase 3
- 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 58 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Osteoarthritis patient (KL classification gr 2-4)
- Primary TKA
- Varus deformity < 20 degree
- Flexion contracture < 20 degree
Who cannot join
- Coagulopathy
- Platelet dysfunction
- Inflammatory arthritis
- Revision TKA
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
Total knee arthroplasty (TKA) is a successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial.
The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA
Read the detailed description
A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)
- Conditions
- Osteoarthritis, Knee
- Being tested
- total knee arthroplasty
- Keywords
- Total knee arthroplasty, Electrocautery, Scalpel, Post-operative pain, Pain score
- Medical subject headings
- Osteoarthritis, Knee, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
total knee arthroplastyProcedure or surgery
total knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach
| Study group | Role | What they receive |
|---|---|---|
| scalpel group | Experimental | Proceed with following step
1. Using electrocautery for stop bleeding at subcutaneous tissue layer
2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament
3. Soft tissue removal and synovial tissue removal
4. No patellar denervation Receives: Procedure: total knee arthroplasty |
| electrocautery group | Experimental | Using an electrocautery in following step
1. Stop bleeding at subcutaneous tissue layer
2. Remove anterior cruciate ligament and posterior cruciate ligament
3. Bony mark for further bone cut
4. Patellar denervation
5. Soft tissue removal
6. Synovial tissue removal Receives: Procedure: total knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (visual analog scale) day 1-4
measure the Postoperative pain by using visual analog scale from 1 - 10, higher scores means worse outcome
Measured: postoperative day 1-4
Secondary outcomes (2)
Calculated blood loss
Calculated blood loss using Mercuruali's formula
Measured: postoperative day 4
Functional score
Functional score using KOOS JR score, range from 0 to 100 with a score of 0 indicating total knee disability and 100 indicating perfect knee health
Measured: follow up 2 weeks, 1,3,6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start11 Oct 2021
- Primary completion31 Dec 2023
- Study completion29 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In electrocautery group, using an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal In scalpel group, proceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Police General Hospital, Thailand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pawut Wattanapongsiri, Police General Hospital, Thailand
- Investigators
- Pawut Wattanapongsiri, Principal investigator, orthopedic department, Police General Hospital, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06239038
- Sponsor's protocol ID
- PGH protocal
- Status last verified
- Feb 2024
- First submitted
- 25 Jan 2024
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Electrocautery Increase Postoperative Pain in Primary Total Knee Arthroplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06239038
- Acronym / sponsor ID
- PGH protocal
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee arthroplasty, Electrocautery, Scalpel, Post-operative pain, Pain score
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Police General Hospital, ThailandUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 2 Feb 2024 (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 successful treatment for end-stage osteoarthritis of the knee. The main advantages of TKA are to relieve the pain of the knee, improve the knee function, restore lower limb alignment, and improve the quality of life for patients. During TKA, some surgeons prefer using a scalpel while others using electrocautery to expose the articular cavity. Whether the use of scalpel can lead to better and faster recovery after the primary TKA is still controversial.
The aim of this study was to compare the clinical outcomes of using the scalpel and the electrocautery in primary TKA
Detailed description
A randomized controlled trial of patients underwent primary TKA between October 2021 and October 2023. The groups will be determined by using the computer to generate a randomization lists. A total 132 patients were included with 66 patients in the scalpel group, 66 patients in the electrocautery group. All patients were evaluated using primary outcome : Post-operative Visual Analog Scale (VAS) of pain, secondary outcome: estimated blood loss and Knee Injury and Osteoarthritis Outcome Score (KOOS-JR)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- In electrocautery group, using an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal In scalpel group, proceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation
| Arm | Type | Receives |
|---|---|---|
| scalpel group | Experimental | Procedure: total knee arthroplastyProceed with following step 1. Using electrocautery for stop bleeding at subcutaneous tissue layer 2. In deep layer still use scalpel for Remove anterior cruciate ligament and posterior cruciate ligament 3. Soft tissue removal and synovial tissue removal 4. No patellar denervation |
| electrocautery group | Experimental | Procedure: total knee arthroplastyUsing an electrocautery in following step 1. Stop bleeding at subcutaneous tissue layer 2. Remove anterior cruciate ligament and posterior cruciate ligament 3. Bony mark for further bone cut 4. Patellar denervation 5. Soft tissue removal 6. Synovial tissue removal |
Who may qualify
- Ages
- 58 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Osteoarthritis patient (KL classification gr 2-4)
- Primary TKA
- Varus deformity < 20 degree
- Flexion contracture < 20 degree
Key exclusion criteria (4 listed)
- Coagulopathy
- Platelet dysfunction
- Inflammatory arthritis
- Revision TKA
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 arthroplastytotal knee arthroplasty surgery with Police Arthroplasty joint academy center(PAJAC) Subvastus Approach | Procedure or surgery | electrocautery group, scalpel group |
Primary outcome
Postoperative pain (visual analog scale) day 1-4
Time frame: postoperative day 1-4
measure the Postoperative pain by using visual analog scale from 1 - 10, higher scores means worse outcome
2 secondary outcomes
Calculated blood loss
Time frame: postoperative day 4
Functional score
Time frame: follow up 2 weeks, 1,3,6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Pawut Wattanapongsiri principal investigator
orthopedic department, Police General Hospital, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing total knee arthroplasty in people with Osteoarthritis, Knee, run by Police General Hospital, Thailand 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 6 Feb 2024. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Postoperative pain (visual analog scale) day 1-4 (time frame: postoperative day 1-4). 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 6 Feb 2024.