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Completed

NCT Number: NCT01470482

Does Tourniquet Use in Total Knee Replacement Improve Fixation

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Hemorrhage Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Motala hospital

Motala, Sweden

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No use of tourniquet

Procedure

Tourniquet is not applied i 25 pts

Other names: No Tourniquet

Tourniquet

Procedure

Use of tourniquet

Primary outcomes

  1. View protocol record

    Time frame: 2 years

    Measures the migration of the knee prosthesis

Secondary outcomes

  1. View Protocol Record

    Time frame: 2 years

    Meassures of total bledding, ROM, KOOS, Pain

Sponsors and collaborators

Lead sponsor

Per Aspenberg

Other

Registry information

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Nov 11, 2011
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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