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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Charlotta Olivecrona, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01442298
First received: September 2, 2011
Last updated: September 27, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention
Complications; Arthroplasty
Procedure: Limb occlusion pressure (LOP)
Procedure: conventional measurement method

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison Between an Individual Low Tourniquet Pressure Versus a Standard Pressure During Total Knee Arthroplasty. A Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Cuff pressure (mmHg) [ Time Frame: participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days ] [ Designated as safety issue: No ]
    For patients in the control group the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon. In the LOP group the tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) by using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus

  • Quality of bloodless field [ Time Frame: particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days ] [ Designated as safety issue: No ]
    Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)


Secondary Outcome Measures:
  • Postoperative pain [ Time Frame: The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery ] [ Designated as safety issue: No ]
    The patients filled in the modified WOMAC scale daily during their hospital stay. The WOMAC is a self -administered and validated health status instrument with 3 domains i.e. pain , physical function and stiffness.A wound control was performed by a ward nurse at discharged. The functional assessment included measurement of the range of motion of the knee joint and a straight leg lifting test (with 1kg weigth) and was performed at third postoperative day by an independent physiotherapist. All patients were followed up two months postoperatively (wound, ROM and WOMAC).

  • Range of motion (ROM) [ Time Frame: The participants were examined at third postoperative day and at the two months follow up after surgery ] [ Designated as safety issue: No ]
  • Postoperative wound complications [ Time Frame: The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery ] [ Designated as safety issue: No ]
  • EMG/EnEG [ Time Frame: Participans were examined day three and two months postoperatively ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: October 2008
Study Completion Date: October 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional treatment
the Standard method;tourniquet pressure based on systolic blood pressure, plus a safety margin.
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.
Experimental: limb occlusion pressure(LOP)
cuff pressure is based on limb occlusion pressure measurement
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®).

  Eligibility

Ages Eligible for Study:   up to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01442298

Locations
Sweden
Department of clinical science and education, Södersjukhuset
Stockholm, Sweden, 11883
Sponsors and Collaborators
Charlotta Olivecrona
  More Information

No publications provided

Responsible Party: Charlotta Olivecrona, RN nurse, OR nurse, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01442298     History of Changes
Other Study ID Numbers: 2007/757-31/1-4
Study First Received: September 2, 2011
Last Updated: September 27, 2011
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska Institutet:
bloodless field
cuff pressure
limb occlusion pressure

ClinicalTrials.gov processed this record on September 18, 2014