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

NCT01442298 | Completed DMC

• 1 other identifier: 2007/757-31/1-4
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

bloodless field; cuff pressure; limb occlusion pressure

Outcome Measures

Primary Outcomes (2)

• Cuff pressure (mmHg)

  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

  participantswill be followed for the duration of hospital stay , an expected avarage of 4-5 days

• Quality of bloodless field

  Direct after surgery the surgeon rated the quality of bloodless fiels on a visual analog scale (VAS)

  particpants will be followed for the duration of the hospital stay, an expected avarage of 4-5 days

Secondary Outcomes (4)

• Postoperative pain

  The participants were followed daily during their hospital stay (4-5 days) and at the two months follow up after surgery

• Range of motion (ROM)

  The participants were examined at third postoperative day and at the two months follow up after surgery

• Postoperative wound complications

  The participants were examined at discharged (day 4 or 5 postoperatively) and at the two months follow up after surgery

• EMG/EnEG

  Participans were examined day three and two months postoperatively

Study Arms (2)

conventional treatment

ACTIVE COMPARATOR

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

Procedure: conventional measurement method

limb occlusion pressure(LOP)

EXPERIMENTAL

cuff pressure is based on limb occlusion pressure measurement

Procedure: Limb occlusion pressure (LOP)

Interventions

Limb occlusion pressure (LOP) 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®).

limb occlusion pressure(LOP)

conventional measurement method 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.

conventional treatment

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Planned for total knee arthroplasty in bloodless field
• year or younger

You may not qualify if:

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

Sponsors & Collaborators

• Charlotta Olivecrona: lead

Study Sites (1)

Department of clinical science and education, Södersjukhuset

Stockholm, 11883, Sweden

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: RN nurse, OR nurse

Study Record Dates

• First Submitted: September 2, 2011
• First Posted: September 28, 2011
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 28, 2011

Record last verified: 2011-09

Locations

SE (1)