Effect of Tourniquet on UKA

Status Not yet recruiting

Clinical 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, 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02465684
Study type	Interventional
Source	Medical University Innsbruck
Contact	Michael Liebensteiner, Assoc. Prof.
Phone	+43 512 50480547
Email	michael.liebensteiner@i-med.ac.at
Status	Not yet recruiting
Phase	N/A
Start date	November 2016

View Details

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