Does Tourniquet Use in Total Knee Replacement Improve Fixation

NCT ID: NCT01470482

Last Updated: 2015-06-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2010-05-31

Brief 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.

Detailed 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

Conditions

Osteoarthritis, Knee

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

No Tourniquet

We compare tourniquet or not in knee surgery

Group Type: OTHER

No use of tourniquet

Intervention Type: PROCEDURE

Tourniquet is not applied i 25 pts

Tourniquet

We compare tourniquet or not in knee surgery

Group Type: ACTIVE_COMPARATOR

Tourniquet

Intervention Type: PROCEDURE

Use of tourniquet

Interventions

No use of tourniquet

Tourniquet is not applied i 25 pts

Intervention Type: PROCEDURE

Tourniquet

Use of tourniquet

Intervention Type: PROCEDURE

Other Intervention Names

No Tourniquet

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Per Aspenberg

OTHER

Sponsor Role: lead

Responsible Party

Per Aspenberg

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Per Aspenberg, MD,PhD

Role: STUDY_DIRECTOR

Linkoeping University

Locations

Motala hospital

Motala, , Sweden

Countries

Sweden

Other Identifiers

VR - 2009-6725).

Identifier Type: OTHER

Identifier Source: secondary_id

Ledin01

Identifier Type: -

Identifier Source: org_study_id