Effect of Tourniquet on UKA

Arthroplasty Clinical Trial

Official title:

The Role of a Thigh Tourniquet in Unicondylar Knee Arthroplasty: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02465684
• Other study ID #: UKA-Tourniquet
• Status: Not yet recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: July 16, 2016
• Start date: November 2016

Study information

• Verified date: July 2016
• Source: Medical University Innsbruck
• Contact: Michael Liebensteiner, Assoc. Prof.
• Phone: +43 512 50480547
• Email: michael.liebensteiner[@]i-med.ac.at
• Is FDA regulated: No
• Health authority: Austria : Federal Ministry for Labour, Health, and Social Affairs
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. primary completion date: January 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

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 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

• Arthroplasty
• Tourniquets

Intervention

Procedure:
• unicondylar knee arthroplasty

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical University Innsbruck	Medical University Linz, Austria

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cement mantle thickness		1 week	Yes