TourniquetsNCT02465684
Effect of Tourniquet on UKA
A study testing unicondylar knee arthroplasty in people with Tourniquets and Arthroplasty, run by Medical University Innsbruck.
Trial summary
There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Tourniquets, Arthroplasty
- What is being tested?
- unicondylar knee arthroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jan 2022
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- waiting list for unicondylar knee arthroplasty
Who cannot join
- failed upper tibial osteotomy,
- insufficiency of the collateral or anterior cruciate ligaments,
- a fixed varus or valgus deformity (not passively correctable) above 15°,
- a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be
- intake of medicinal anticoagulation prior to surgery
- liver dysfunction / coagulation dysfunction
- peripheral arterial obstructive disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial
There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty.
It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process.
Read more
Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation.
Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.
The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position \& sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.
- Conditions
- Tourniquets, Arthroplasty
- Being tested
- unicondylar knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unicondylar knee arthroplastyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| tourniquet | Experimental | UKA surgery with tourniquet Receives: Procedure: unicondylar knee arthroplasty |
| no tourniquet | Experimental | UKA without tourniquet Receives: Procedure: unicondylar knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
cement mantle thickness
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2015 (estimated)
- Study startNov 2016
- Primary completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TourniquetsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University Linz, Austria
- Responsible party
- Principal investigator, Michael Liebensteiner, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02465684
- Sponsor's protocol ID
- UKA-Tourniquet
- Status last verified
- Jul 2016
- First submitted
- 4 Jun 2015
- Last updated
- 19 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02465684
- Acronym / sponsor ID
- UKA-Tourniquet
- Conditions
- Tourniquets, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Medical University Linz, Austria
- Study start
- Nov 2016
- Primary completion
- Jan 2022 (estimated)
- First posted
- 8 Jun 2015 (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.
There is obviously a lack of evidence regarding the risk-benefit ratio of a thigh tourniquet in unicondylar knee arthroplasty (UKA). This refers to many possible outcome criteria like operating time, blood loss, quality of prosthesis fixation in the bone, adverse events, radiographic result, clinical score outcome, easy of rehabilitation etc. It is not appropriate to rely on findings from the field of total knee arthroplasty.
It is the aim of the current study, to clarify the role of a thigh tourniquet during UKA with regard to component fixation quality, component positioning and sizing, clinical outcome and rehabilitation process.
Patients scheduled for routine UKA implantation due to osteoarthritis or osteonecrosis in the medial compartment will be considered for participation.
Patients are then randomized for surgery with or without tourniquet. After an anteromedial Quad-Sparing approach the UKA procedure itself is then carried out, as suggested by the manufacturer. For both groups puls lavage and meticulous drying is applied before cementing.
The following outcome parameters are assessed: 1)radiographic cement mantle thickness, 2)component position \& sizing, 3)diolucencies, 4)score outcome and 5)parameters of early Rehab.
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 |
|---|---|---|
| tourniquet | Experimental | Procedure: unicondylar knee arthroplastyUKA surgery with tourniquet |
| no tourniquet | Experimental | Procedure: unicondylar knee arthroplastyUKA without tourniquet |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- waiting list for unicondylar knee arthroplasty
Key exclusion criteria (7 listed)
- failed upper tibial osteotomy,
- insufficiency of the collateral or anterior cruciate ligaments,
- a fixed varus or valgus deformity (not passively correctable) above 15°,
- a flexion deformity greater than 15° and 5) rheumatoid arthritis. In addition - with regard to the scope of the current study - further exclusion criteria will be
- intake of medicinal anticoagulation prior to surgery
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 |
|---|---|---|
| unicondylar knee arthroplasty | Procedure or surgery | no tourniquet, tourniquet |
Primary outcome
cement mantle thickness
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2016.
Related trials for Tourniquets
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Reducing Blood Loss During Myomectomy by Comparing Local Epinephrine and Uterine Artery Tourniquet During Procedure
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Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
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Healthy Adults Aged 18-55, Three Ukrainian Windlass Tourniquets (SICH, DNIPRO GEN 2, PULS) Compared With CAT Gen 7, and Complete Limb Arterial Occlusion Confirmed by Doppler.
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Effect of Tourniquet Use on the Pivot Shift Test
Anterior Cruciate Ligament Injury
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Wide-Awake Local Anesthesia No-Tourniquet (WALANT) Procedures
Hand Injuries and Disorders
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.
Questions about this trial
What is this clinical trial studying?
A study testing unicondylar knee arthroplasty in people with Tourniquets and Arthroplasty, run by Medical University Innsbruck.
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 7 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 19 Jul 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael Liebensteiner, Assoc. Prof. (+43 512 50480547, michael.liebensteiner@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cement mantle thickness (time frame: 1 week). 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 19 Jul 2016.