Does Tourniquet Use in Total Knee Replacement Improve Fixation

Osteoarthritis, Knee Clinical Trial

Official title:

Does Tourniquet Use in Total Knee Replacement Improve Fixation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01470482
• Other study ID #: Ledin01
• Secondary ID: VR - 2009-6725).
• Status: Completed
• Phase: Phase 3
• First received: November 3, 2011
• Last updated: June 8, 2015
• Start date: August 2006
• Est. completion date: May 2010

Study information

• Verified date: June 2015
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Although a tourniquet may reduce bleeding during total knee replacement (TKA), and thereby improve fixation, it might also cause complications. Migration as measured by RadioStereometric Analysis (RSA) can predict future loosening. We will investigate if the use of a tourniquet influences fixation measured with RSA.

Description:

The use of a tourniquet during total knee replacement (TKA) is a generally accepted routine at many departments. It is thought to facilitate dissection and reduce peroperative bleeding, but the main argument for its use is that bleeding bone surfaces might impair the fixation of cemented prostheses, because of less cement penetration.

We investigate in a RCT 50 patient with radiostereometric analysis, where 25 is randomized to a tourniquet during the hole operation and 25 are not.

Primary outcome is MTPM, a meassure of migration(loosening) of the kneeprosthesis.

Secondary outcomes are total bleeeding, pain, range of motion and outcome of a patient self assesed knee score (KOOS) Total follow up time 2 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

Inclusion Criteria:

• primary or secondary osteoarthritis without other severe disease (ASA 1-2).

Exclusion Criteria:

• were inability to give informed consent,

• rheumatic arthritis,

• malignancy,

• coagulation disorder or medical treatment influencing the coagulation,

• liver disease,

• severe heart disease or bilateral operation.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis, Knee

Intervention

Procedure:
• No use of tourniquet
Tourniquet is not applied i 25 pts
• Tourniquet
Use of tourniquet

Locations

Country	Name	City	State
Sweden	Motala hospital	Motala

Sponsors (1)

Lead Sponsor	Collaborator
Per Aspenberg

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	View protocol record	Measures the migration of the knee prosthesis	2 years	No
Secondary	View Protocol Record	Meassures of total bledding, ROM, KOOS, Pain	2 years	No