Effect of Tourniquet on UKA

NCT ID: NCT02465684

Last Updated: 2016-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tourniquets Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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tourniquet

UKA surgery with tourniquet

Group Type EXPERIMENTAL

unicondylar knee arthroplasty

Intervention Type PROCEDURE

no tourniquet

UKA without tourniquet

Group Type EXPERIMENTAL

unicondylar knee arthroplasty

Intervention Type PROCEDURE

Interventions

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unicondylar knee arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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°,
* intake of medicinal anticoagulation prior to surgery
* liver dysfunction / coagulation dysfunction
* peripheral arterial obstructive disease.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University Linz, Austria

UNKNOWN

Sponsor Role collaborator

Medical University Innsbruck

OTHER

Sponsor Role lead

Responsible Party

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Michael Liebensteiner

Michael Liebensteiner MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Michael Liebensteiner, Assoc. Prof.

Role: CONTACT

+43 512 50480547

Other Identifiers

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UKA-Tourniquet

Identifier Type: -

Identifier Source: org_study_id

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