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A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty

NCT01442298 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2011-09-28

No results posted yet for this study

Summary

The use of bloodless field is a helpful and important method in orthopedic surgery. The surgery can be done without interrupting bleedings, while keeping an exact overlook of the anatomy. However the method is not without risks, and complications of various kind may occur. One of the most important factors to minimise the risk of complications, is to keep the lowest possible cuff pressure. Previous electromyography (EMG) studies have indicated neuromuscular abnormalities after bloodless field among many patients which may lead to a prolonged rehabilitation period since they cause a postoperative weakness in the muscles. Although in these studies an unnecessary high tourniquet pressures were used and the EMG tests were made 6 weeks and 6 months after the surgery.

With today's demand for fast rehabilitation, there is a need for better knowledge if lower tourniquet pressure in bloodless field surgery may lead to less neuromuscular abnormalities.

Limb Occlusion Pressure (LOP) is the tourniquet cuff pressure required to occlude the blood flow. It accounts for a patients limb and vessel characteristics and the type and fit of the tourniquet cuff. The method has developed and is now simplified, by using an automatic (plethysmographic) sensor placed on the second toe on the involved limb, and after administration of anaesthesia, and immediately before limb preparation and draping it measures the limb occlusion pressure.

When surgery starts, the cuff is inflated again; plus a safety margin based on the LOP pressure measured. The LOP method is still rarely used it has been seen as difficult and time consuming.

The primary aim of this study is to investigate whether you can reduce the used tourniquet pressure with the new LOP measurement technique and still have a adequate bloodless field; and if this will lead to any clinical difference regarding postoperative pain. The secondary aim is to investigate the difference between the test groups concerning muscle function and wound healing and if these are remaining and of clinical importance. The third aim is to study how common neuromuscular abnormalities are after the use of bloodless field with lower cuff pressures and if there are any differences between the standard method and the LOP method.

Conditions

  • Complications; Arthroplasty

Interventions

PROCEDURE

Limb occlusion pressure (LOP)

The tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus (Zimmer Sweden Inc®).

PROCEDURE

conventional measurement method

Standard method at our department, the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon.

Sponsors & Collaborators

  • Charlotta Olivecrona

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-10-31
Primary Completion
2010-07-31
Completion
2010-10-31

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01442298 on ClinicalTrials.gov