Effect of Tourniquet on UKA

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.

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 Overview

• Status: Unknown
• Conditions: Arthroplasty; Tourniquets
• Intervention / Treatment: Procedure: unicondylar knee arthroplasty

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Liebensteiner, Assoc. Prof.; Phone Number: +43 512 50480547; Email: michael.liebensteiner@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• waiting list for unicondylar knee arthroplasty

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tourniquet; UKA surgery with tourniquet	Procedure: unicondylar knee arthroplasty
Experimental: no tourniquet; UKA without tourniquet	Procedure: unicondylar knee arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cement mantle thickness	1 week

Collaborators and Investigators

• Sponsor: Medical University Innsbruck
• Collaborators: Medical University Linz, Austria

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: June 4, 2015
• First Submitted That Met QC Criteria: June 5, 2015
• First Posted (Estimate): June 8, 2015

Study Record Updates

• Last Update Posted (Estimate): July 19, 2016
• Last Update Submitted That Met QC Criteria: July 16, 2016
• Last Verified: July 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: UKA-Tourniquet