Osteoarthritis, KneePhase 3NCT01470482
Does Tourniquet Use in Total Knee Replacement Improve Fixation
A Phase 3 study testing No use of tourniquet and Tourniquet in people with Osteoarthritis, Knee, run by Per Aspenberg at 1 site in Sweden.
Trial summary
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- No use of tourniquet and Tourniquet
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2006to May 2010
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- primary or secondary osteoarthritis without other severe disease (ASA 1-2).
Who cannot join
- were inability to give informed consent,
- rheumatic arthritis,
- malignancy,
- coagulation disorder or medical treatment influencing the coagulation,
- liver disease,
- severe heart disease or bilateral operation.
Trial locations and contacts
1 site in 1 country.
About this study
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
Read the detailed description
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.
We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.
Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.
Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years
- Conditions
- Osteoarthritis, Knee
- Being tested
- No use of tourniquet, Tourniquet
- Keywords
- Total knee, Tourniquet, Blood loss, pain, range of motion
- Medical subject headings
- Osteoarthritis, Knee, Hemorrhage, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No use of tourniquetProcedure or surgery
Also called No Tourniquet
Tourniquet is not applied i 25 pts
TourniquetProcedure or surgery
Use of tourniquet
| Study group | Role | What they receive |
|---|---|---|
| No Tourniquet | Other | We compare tourniquet or not in knee surgery Receives: Procedure: No use of tourniquet |
| Tourniquet | Active comparator | We compare tourniquet or not in knee surgery Receives: Procedure: Tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
View protocol record
Measures the migration of the knee prosthesis
Measured: 2 years
Secondary outcomes (1)
View Protocol Record
Meassures of total bledding, ROM, KOOS, Pain
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startAug 2006
- Primary completionMay 2010
- Study completionMay 2010
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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Aspenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Per Aspenberg, University Hospital, Linkoeping
- Investigators
- Per Aspenberg, MD,PhD, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470482
- Sponsor's protocol ID
- Ledin01
- Other IDs
- VR - 2009-6725).
- Status last verified
- Jun 2015
- First submitted
- 3 Nov 2011
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Tourniquet Use in Total Knee Replacement Improve Fixation
- ClinicalTrials.gov ID
- NCT01470482
- Acronym / sponsor ID
- Ledin01
- Conditions
- Osteoarthritis, Knee
- Keywords
- Total knee, Tourniquet, Blood loss, pain, range of motion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Per AspenbergUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 11 Nov 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.
Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.
Detailed description
The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.
We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.
Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.
Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Tourniquet | Other | Procedure: No use of tourniquetWe compare tourniquet or not in knee surgery |
| Tourniquet | Active comparator | Procedure: TourniquetWe compare tourniquet or not in knee surgery |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- primary or secondary osteoarthritis without other severe disease (ASA 1-2).
Key exclusion criteria (6 listed)
- were inability to give informed consent,
- rheumatic arthritis,
- malignancy,
- coagulation disorder or medical treatment influencing the coagulation,
- liver disease,
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 |
|---|---|---|
| No use of tourniquetAlso: No TourniquetTourniquet is not applied i 25 pts | Procedure or surgery | No Tourniquet |
| TourniquetUse of tourniquet | Procedure or surgery | Tourniquet |
Primary outcome
View protocol record
Time frame: 2 years
Measures the migration of the knee prosthesis
1 secondary outcome
View Protocol Record
Time frame: 2 years
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 Jun 2015.
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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.
Per Aspenberg, MD,PhD study director
Linkoeping University
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 No use of tourniquet and Tourniquet in people with Osteoarthritis, Knee, run by Per Aspenberg 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 1 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 Jun 2015. 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.
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?
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?
View protocol record (time frame: 2 years). 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 Jun 2015.