Tourniquet and Outcome After Total Knee ReplacementNCT06228651
The Effect of the Tourniquet in Bilateral Total Knee Replacement
A study testing Tourniquet and The leg without the tourniquet in people with Tourniquet and Outcome After Total Knee Replacement, run by Odense University Hospital.
Trial summary
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tourniquet and Outcome After Total Knee Replacement
- What is being tested?
- Tourniquet and The leg without the tourniquet
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2016to 21 Dec 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification
Who cannot join
- non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis
About this study
Official title: The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
Read the detailed description
Background: Tourniquet application during total knee arthroplasty (TKA) is a common practice aimed at reducing intraoperative bleeding. However, concerns have been raised about potential tissue damage from ischemia and reperfusion injury.
Objectives: This study examines the effects of tourniquet use during TKA on postoperative functional outcomes, including pain, range of motion (ROM), and patient-reported outcomes (PROMs).
Methods: In a fast-track surgical setting, a prospective, randomized, double-blinded trial was conducted with patients undergoing bilateral TKA. Tourniquets were applied to one knee, while the contralateral knee served as a control. Evaluations were conducted at two and four weeks, and at three and twelve months postoperatively, employing paired t-tests and mixed-effects linear modeling for data analysis.
- Being tested
- Tourniquet, The leg without the tourniquet
- Keywords
- Tourniquet, Total knee replacement, Oxford knee score, Forgotten Joint Score
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TourniquetDevice
The leg without the tourniquetOther
| Study group | Role | What they receive |
|---|---|---|
| Tourniquet | Active comparator | The leg with the tourniquet which was inflated during surgery Receives: Device: Tourniquet |
| Control | Active comparator | The leg without the tourniquet which was not inflated during surgery Receives: Other: The leg without the tourniquet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Pain at rest evaluated at a visual analogue scale (VAS)
Measured: 2 weeks postoperatively
Secondary outcomes (2)
Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)
Patient reported outcome
Measured: two weeks, four weeks, three months and one year postop
Wound complications and deep vein thrombosis and re-admissions
Measured: within one year postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start14 Mar 2016
- Primary completion1 Mar 2021
- Study completion21 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tourniquet and Outcome After Total Knee ReplacementStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- 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
- Single group
- Model description
- We conducted a prospective, randomized, double -blinded trial including patients with simultaneously performed bilateral TKA in a fast-track setup at Lillebaelt Hospital - Vejle, Denmark. After randomization, tourniquet was inflated to only one knee facilitating direct comparison with patients acting as their own controls. Postoperative evaluations were performed at predetermined intervals. Patient reported outcomes were measured for the following year postoperative
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228651
- Sponsor's protocol ID
- s-20150100
- Status last verified
- Jan 2024
- First submitted
- 19 Jan 2024
- Last updated
- 29 Jan 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 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Functional Outcome of the Arterial Tourniquet in Total Knee Arthroplasty- a RCT of Bilateral Total Knee Arthroplasties.
- ClinicalTrials.gov ID
- NCT06228651
- Acronym / sponsor ID
- s-20150100
- Keywords
- Tourniquet, Total knee replacement, Oxford knee score, Forgotten Joint Score
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 21 Dec 2023 (actual)
- First posted
- 29 Jan 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.
This study describes in a randomised controlled trial how the tourniquet influence the outcome af a total knee replacements
Detailed description
Background: Tourniquet application during total knee arthroplasty (TKA) is a common practice aimed at reducing intraoperative bleeding. However, concerns have been raised about potential tissue damage from ischemia and reperfusion injury.
Objectives: This study examines the effects of tourniquet use during TKA on postoperative functional outcomes, including pain, range of motion (ROM), and patient-reported outcomes (PROMs).
Methods: In a fast-track surgical setting, a prospective, randomized, double-blinded trial was conducted with patients undergoing bilateral TKA. Tourniquets were applied to one knee, while the contralateral knee served as a control. Evaluations were conducted at two and four weeks, and at three and twelve months postoperatively, employing paired t-tests and mixed-effects linear modeling for data analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- We conducted a prospective, randomized, double -blinded trial including patients with simultaneously performed bilateral TKA in a fast-track setup at Lillebaelt Hospital - Vejle, Denmark. After randomization, tourniquet was inflated to only one knee facilitating direct comparison with patients acting as their own controls. Postoperative evaluations were performed at predetermined intervals. Patient reported outcomes were measured for the following year postoperative
| Arm | Type | Receives |
|---|---|---|
| Tourniquet | Active comparator | Device: TourniquetThe leg with the tourniquet which was inflated during surgery |
| Control | Active comparator | Other: The leg without the tourniquetThe leg without the tourniquet which was not inflated during surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Aged 18 years or older, planned for bilateral cemented primary TKA due to osteoarthritis during the same session. and showed a uniform degree of osteoarthritis determined by the Kellgren-Lawrence classification
Key exclusion criteria (1 listed)
- non-Danish speaking patients, unable to cooperate for VAS scoring, coagulation disorders, salicylate-induced asthma, severe thrombocytopenia, serious heart failure, severe liver failure, hypovolemia (any cause), dehydration, angioedema, bronchospasm, undergoing lithium treatment, suspected or manifest gastrointestinal bleeding, cerebrovascular bleeding, high postoperative bleeding risk or delayed hemostasis, hypersensitivity to adrenaline, sympathomimetics or excipients , hypertrophic or ischemic heart disease, undergoing dihydroergotamine treatment and thyrotoxicosis
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 |
|---|---|---|
| Tourniquet | Device | Tourniquet |
| The leg without the tourniquet | Other | Control |
Primary outcome
Postoperative pain
Time frame: 2 weeks postoperatively
Pain at rest evaluated at a visual analogue scale (VAS)
2 secondary outcomes
Forgotten Joint Score (FJS) and Oxford Knee Score (OKS)
Time frame: two weeks, four weeks, three months and one year postop
Wound complications and deep vein thrombosis and re-admissions
Time frame: within one year postop
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 29 Jan 2024.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A study testing Tourniquet and The leg without the tourniquet in people with Tourniquet and Outcome After Total Knee Replacement, run by Odense University Hospital.
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 1 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 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Postoperative pain (time frame: 2 weeks postoperatively). 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 29 Jan 2024.