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Effect of Tourniquet on UKA

NCT02465684 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-07-19

No results posted yet for this study

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.

Conditions

  • Tourniquets
  • Arthroplasty

Interventions

PROCEDURE

unicondylar knee arthroplasty

Sponsors & Collaborators

  • Medical University Linz, Austria

    collaborator UNKNOWN

  • Medical University Innsbruck

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2022-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02465684 on ClinicalTrials.gov