Complications; ArthroplastyNCT01442298
A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty
A study testing Limb occlusion pressure (LOP) and conventional measurement method in people with Complications; Arthroplasty, run by Charlotta Olivecrona at 1 site in Sweden.
Trial summary
The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. Read more about this study
- Who is it for?
- Ages Up to 75 years
- Conditions the study is for
- Complications; Arthroplasty
- What is being tested?
- Limb occlusion pressure (LOP) and conventional measurement method
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2008to Oct 2010
- 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 Up to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Planned for total knee arthroplasty in bloodless field
- 75 year or younger
Who cannot join
- Patients unable to read and understand Swedish
- Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of clinical science and education, Södersjukhuset
Stockholm, 11883
About this study
Official title: A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty. A Randomized Controlled Study
The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery.
With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.
Read more
Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure.
When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming.
The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.
- Conditions
- Complications; Arthroplasty
- Being tested
- Limb occlusion pressure (LOP), conventional measurement method
- Keywords
- bloodless field, cuff pressure, limb occlusion pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Limb occlusion pressure (LOP)Procedure or surgery
The tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus (Zimmer Sweden Inc®).
conventional measurement methodProcedure or surgery
Standard method at our department, the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon.
| Study group | Role | What they receive |
|---|---|---|
| conventional treatment | Active comparator | the Standard method;tourniquet pressure based on systolic blood pressure, plus a safety margin. Receives: Procedure: conventional measurement method |
| limb occlusion pressure(LOP) | Experimental | cuff pressure is based on limb occlusion pressure measurement Receives: Procedure: Limb occlusion pressure (LOP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cuff pressure (mmHg)
For patients in the control group the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. In the LOP group the tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) by using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus
Measured: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days
Quality of bloodless field
Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)
Measured: particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days
Secondary outcomes (4)
Postoperative pain
The patients filled in the modified WOMAC scale daily during their hospital stay. The WOMAC is a self -administered and validated health status instrument with 3 domains i.e. pain , physical function and stiffness.A wound control was performed by a ward nurse at discharged. The functional assessment included measurement of the range of motion of the knee joint and a straight leg lifting test (with 1kg weigth) and was performed at third postoperative day by an independent physiotherapist. All patients were followed up two months postoperatively (wound, ROM and WOMAC).
Measured: The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery
Range of motion (ROM)
Measured: The participants were examined at third postoperative day and at the two months follow up after surgery
Postoperative wound complications
Measured: The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery
EMG/EnEG
Measured: Participans were examined day three and two months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startOct 2008
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Complications; 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charlotta Olivecrona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charlotta Olivecrona, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442298
- Sponsor's protocol ID
- 2007/757-31/1-4
- Status last verified
- Sep 2011
- First submitted
- 2 Sep 2011
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty. A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT01442298
- Acronym / sponsor ID
- 2007/757-31/1-4
- Conditions
- Complications; Arthroplasty
- Keywords
- bloodless field, cuff pressure, limb occlusion pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Charlotta OlivecronaUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 28 Sep 2011 (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.
The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery.
With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.
Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure.
When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming.
The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional treatment | Active comparator | Procedure: conventional measurement methodthe Standard method;tourniquet pressure based on systolic blood pressure, plus a safety margin. |
| limb occlusion pressure(LOP) | Experimental | Procedure: Limb occlusion pressure (LOP)cuff pressure is based on limb occlusion pressure measurement |
Who may qualify
- Ages
- Up to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Planned for total knee arthroplasty in bloodless field
- 75 year or younger
Key exclusion criteria (2 listed)
- Patients unable to read and understand Swedish
- Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.
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 |
|---|---|---|
| Limb occlusion pressure (LOP)The tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus (Zimmer Sweden Inc®). | Procedure or surgery | limb occlusion pressure(LOP) |
| conventional measurement methodStandard method at our department, the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. | Procedure or surgery | conventional treatment |
Primary outcome
Cuff pressure (mmHg)
Time frame: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days
For patients in the control group the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. In the LOP group the tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) by using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus
Quality of bloodless field
Time frame: particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days
Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)
4 secondary outcomes
Postoperative pain
Time frame: The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery
Range of motion (ROM)
Time frame: The participants were examined at third postoperative day and at the two months follow up after surgery
Postoperative wound complications
Time frame: The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery
EMG/EnEG
Time frame: Participans were examined day three and two months postoperatively
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 28 Sep 2011.
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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 Limb occlusion pressure (LOP) and conventional measurement method in people with Complications; Arthroplasty, run by Charlotta Olivecrona at 1 site in Sweden.
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 2 inclusion and 2 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 28 Sep 2011. 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 Sweden. 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?
Cuff pressure (mmHg) (time frame: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days). The study lists 2 primary outcomes in all. 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 28 Sep 2011.