Effect of Tourniquet on UKA
The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial
1 other identifier
interventional
30
0 countries
N/A
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2015
CompletedFirst Posted
Study publicly available on registry
June 8, 2015
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedJuly 19, 2016
July 1, 2016
5.2 years
June 4, 2015
July 16, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
cement mantle thickness
1 week
Study Arms (2)
tourniquet
EXPERIMENTALUKA surgery with tourniquet
no tourniquet
EXPERIMENTALUKA without tourniquet
Interventions
Eligibility Criteria
You may qualify if:
- waiting list for unicondylar knee arthroplasty
You may not qualify if:
- failed upper tibial osteotomy,
- insufficiency of the collateral or anterior cruciate ligaments,
- a fixed varus or valgus deformity (not passively correctable) above 15°,
- intake of medicinal anticoagulation prior to surgery
- liver dysfunction / coagulation dysfunction
- peripheral arterial obstructive disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University Innsbrucklead
- Medical University Linz, Austriacollaborator
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Michael Liebensteiner MD, PhD
Study Record Dates
First Submitted
June 4, 2015
First Posted
June 8, 2015
Study Start
November 1, 2016
Primary Completion
January 1, 2022
Last Updated
July 19, 2016
Record last verified: 2016-07