Does Tourniquet Use in Total Knee Replacement Improve Fixation

Per Aspenberg

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis, Knee

Treatments: Procedure: Tourniquet; Procedure: No use of tourniquet

Study type: Interventional

Funder types: Other

Identifiers

NCT01470482

VR - 2009-6725). (Other Identifier)

Ledin01

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

No Tourniquet

Other group

Description:

We compare tourniquet or not in knee surgery

Treatment:

Procedure: No use of tourniquet

Tourniquet

Active Comparator group

Description:

We compare tourniquet or not in knee surgery

Treatment:

Procedure: Tourniquet