MedDataX Logo

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

NCT ID: NCT01442298

Last Updated: 2011-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-10-31

Study Completion Date

2010-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Complications; Arthroplasty

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

conventional treatment

the Standard method;tourniquet pressure based on systolic blood pressure, plus a safety margin.

Group Type ACTIVE_COMPARATOR

conventional measurement method

Intervention Type PROCEDURE

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.

limb occlusion pressure(LOP)

cuff pressure is based on limb occlusion pressure measurement

Group Type EXPERIMENTAL

Limb occlusion pressure (LOP)

Intervention Type PROCEDURE

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®).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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®).

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Planned for total knee arthroplasty in bloodless field
* 75 year or younger

Exclusion Criteria

* Patients unable to read and understand Swedish
* Systolic blood pressure over 200 mmHg and a girth of the thigh over 78 cm was excluded.
Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Charlotta Olivecrona

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Charlotta Olivecrona

RN nurse, OR nurse

Responsibility Role SPONSOR_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of clinical science and education, Södersjukhuset

Stockholm, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2007/757-31/1-4

Identifier Type: -

Identifier Source: org_study_id