Osteo Arthritis KneeNCT03559478
Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet
A study testing Sharp dissection with scalpel plus electrocautery to vessels and Electrocautery for all dissection in people with Osteo Arthritis Knee and Arthroplasty, Replacement, Knee, run by Royal Infirmary of Edinburgh at 1 site in United Kingdom.
Trial summary
This study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. Half of the patients will be randomly assigned each intervention. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Osteo Arthritis Knee, Arthroplasty, Replacement, Knee
- What is being tested?
- Sharp dissection with scalpel plus electrocautery to vessels and Electrocautery for all dissection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2018to Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Primary knee osteoarthritis requiring TKA (total knee arthroplasty)
- Planned for cruciate retaining prosthesis without patella resurfacing
- Patient is able to give informed consent
- Patient resides locally and will be available for follow up
Who cannot join
- Cardiac pacemaker
- Inflammatory arthropathy
- Tourniquet contraindicated
- Thrombophilia/haemoglobinopathy
- Spinal anaesthetic not possible
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Infirmary of Edinburgh
Edinburgh, Midlothian, EH16 4SA
Chloe EH Scott, MD MSc, 01312423484, chloe.scott@nhslothian.scot.nhs.uk
About this study
Official title: Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet: a Randomized Double Blind Controlled Trial
This study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. Half of the patients will be randomly assigned each intervention.
Read the detailed description
The approach to the knee to carry out a total knee replacement (TKR) can either be carried out using a scalpel, sharp dissection, or using an electric current to divide tissue, monopoly electrocautery. Reducing blood loss is important. Blood loss can result in anaemia, which has a number of effects including shortness of breath, chest pain and lethargy. Blood loss into a newly replaced knee can also result in pain and stiffness in the joint. Total knee replacements are routinely carried out with a tourniquet inflated, which reduces the blood flow into to leg during the operation. Diathermy is applied to areas of bleeding to stop them from doing so during operations. With the tourniquet inflated, some areas that would bleed when this was deflated may not be noticed and continue to bleed. Using diathermy for the approach would be expected to reduce this bleeding compared to using a scalpel.
- Being tested
- Sharp dissection with scalpel plus electrocautery to vessels, Electrocautery for all dissection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sharp dissection with scalpel plus electrocautery to vesselsProcedure or surgery
A scalpel will be used for dissection for TKA implantation. Bleeding vessels will be managed as encountered with electrocautery. Electrocautery will not be used for dissection.
Electrocautery for all dissectionProcedure or surgery
Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group 1 | Active comparator | Sharp dissection with scalpel plus electrocautery to vessels Receives: Procedure: Sharp dissection with scalpel plus electrocautery to vessels |
| Treatment Group 2 | Active comparator | Electrocautery for all dissection Receives: Procedure: Electrocautery for all dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
24hr Calculated blood loss
Will be done using the Nadler and Gross formulae
Measured: 1 day
Secondary outcomes (7)
Haemoglobin drop
Haemoglobin drop from day 1 full blood count test
Measured: 1 day
Transfusion requirement
If the patient requires blood transfusion or not
Measured: 2 days
VAS (Visual Analogue Scale) pain score 24 and 48 hrs
Patient's pain score at 24 and 48 hours post-operatively
Measured: 2 days
Range of motion 48hrs and 6 weeks
Knee range of motion in degrees at 48 hours and 6 weeks post-operatively
Measured: 6 weeks
Length of hospital stay
Length of inpatient stay in hospital
Measured: 2 weeks
Improvement in Oxford knee score at 12 months
Oxford Knee Score, designed to assess function and pain after total knee replacement. Scored from 0 (severe knee symptoms with functional limitation) to 60 (absence of pain and limitations)
Measured: 12 months
Adverse events
Any complications encountered
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2018
- Study startNov 2018 (estimated)
- Primary completionApr 2021 (estimated)
- Study completionApr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 70 participants will be randomized in a 1:1 ratio to either Treatment Group 1 (sharp dissection with scalpel plus electrocautery to obvious vessels) or Treatment Group 2 (electrocautery for all dissection) using the sealed opaque envelope randomization technique.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Infirmary of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chloe Scott, Royal Infirmary of Edinburgh
- Investigators
- Chloe EH Scott, MD MSc, Principal investigator, Consultant Trauma and Orthopaedic Surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03559478
- Sponsor's protocol ID
- 244896
- Status last verified
- Oct 2018
- First submitted
- 10 Apr 2018
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- 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 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sharp Dissection Versus Monopolar Electrocautery in Primary Total Knee Arthroplasty Performed Under Tourniquet: a Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT03559478
- Acronym / sponsor ID
- 244896
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Royal Infirmary of EdinburghUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Apr 2021 (estimated)
- First posted
- 18 Jun 2018 (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.
This study compares the use of sharp dissection with diathermy for the approach to a total knee replacement. Half of the patients will be randomly assigned each intervention.
Detailed description
The approach to the knee to carry out a total knee replacement (TKR) can either be carried out using a scalpel, sharp dissection, or using an electric current to divide tissue, monopoly electrocautery. Reducing blood loss is important. Blood loss can result in anaemia, which has a number of effects including shortness of breath, chest pain and lethargy. Blood loss into a newly replaced knee can also result in pain and stiffness in the joint. Total knee replacements are routinely carried out with a tourniquet inflated, which reduces the blood flow into to leg during the operation. Diathermy is applied to areas of bleeding to stop them from doing so during operations. With the tourniquet inflated, some areas that would bleed when this was deflated may not be noticed and continue to bleed. Using diathermy for the approach would be expected to reduce this bleeding compared to using a scalpel.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A total of 70 participants will be randomized in a 1:1 ratio to either Treatment Group 1 (sharp dissection with scalpel plus electrocautery to obvious vessels) or Treatment Group 2 (electrocautery for all dissection) using the sealed opaque envelope randomization technique.
| Arm | Type | Receives |
|---|---|---|
| Treatment Group 1 | Active comparator | Procedure: Sharp dissection with scalpel plus electrocautery to vesselsSharp dissection with scalpel plus electrocautery to vessels |
| Treatment Group 2 | Active comparator | Procedure: Electrocautery for all dissectionElectrocautery for all dissection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Primary knee osteoarthritis requiring TKA (total knee arthroplasty)
- Planned for cruciate retaining prosthesis without patella resurfacing
- Patient is able to give informed consent
- Patient resides locally and will be available for follow up
Key exclusion criteria (5 listed)
- Cardiac pacemaker
- Inflammatory arthropathy
- Tourniquet contraindicated
- Thrombophilia/haemoglobinopathy
- Spinal anaesthetic not possible
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 |
|---|---|---|
| Sharp dissection with scalpel plus electrocautery to vesselsA scalpel will be used for dissection for TKA implantation. Bleeding vessels will be managed as encountered with electrocautery. Electrocautery will not be used for dissection. | Procedure or surgery | Treatment Group 1 |
| Electrocautery for all dissectionSkin incision will be made with a scalpel, but all other dissection will be performed with electrocautery. | Procedure or surgery | Treatment Group 2 |
Primary outcome
24hr Calculated blood loss
Time frame: 1 day
Will be done using the Nadler and Gross formulae
7 secondary outcomes
Haemoglobin drop
Time frame: 1 day
Transfusion requirement
Time frame: 2 days
VAS (Visual Analogue Scale) pain score 24 and 48 hrs
Time frame: 2 days
Range of motion 48hrs and 6 weeks
Time frame: 6 weeks
Length of hospital stay
Time frame: 2 weeks
Improvement in Oxford knee score at 12 months
Time frame: 12 months
Adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Individual participant dataSharing planned: No
Related trials for Osteo Arthritis Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis 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.
Chloe EH Scott, MD MSc principal investigator
Consultant Trauma and Orthopaedic Surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sharp dissection with scalpel plus electrocautery to vessels and Electrocautery for all dissection in people with Osteo Arthritis Knee and Arthroplasty, Replacement, Knee, run by Royal Infirmary of Edinburgh 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 4 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: status not confirmed, as of the sponsor's last update on 9 Oct 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chloe EH Scott, MD MSc (01312423484, chloe.scott@nhslothian.scot.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24hr Calculated blood loss (time frame: 1 day). 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 Oct 2018.