Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy

November 23, 2010 updated by: Karolinska Institutet

Abstract

Background:

Local external cooling of the postoperative field is a treatment paradigm aiming for enhanced recovery after joint surgery. It is supposed to reduce pain and improve mobilization, enabling same day surgery.

Hypothesis:

Systematic postoperative cooling and compression after knee arthroscopy will reduce pain and also be reflected by changes in local levels of metabolic and inflammatory variables in the synovial membrane.

Study design:

Prospective randomised study; Level of evidence 1.

Methods:

Forty-four otherwise healthy patients were included in the study and randomised to systematic cooling and compression or NO cooling and compression after knee arthroscopy. Microdialysis of the synovial membrane was performed postoperatively with measurements of PGE2, glucose, lactate, glycerol, glutamate and blood flow (ethanol exchange ratio). Local temperature was monitored as well as postoperative pain (VAS and NRS).

Results:

The application of a cooling and compression device after knee arthroscopy resulted in significantly lower temperature in the operated knee (skin, joint capsule and intraarticularly).

The cooling and compression diminished energy requirements in synovial tissue and a 3 temperature sensitive influence on inflammation (PGE2) were shown. No effect on postoperative pain was detected.

Conclusion:

Local cryotherapy and compression after knee arthroscopy significantly lowered local knee temperature postoperatively. A correlation with synovial PGE 2 and temperature was shown.

Since PGE2 is a pain and inflammatory marker this implicates a positive anti-inflammatory effect induced by postoperative local cooling and compression. Hypothermia is proposed to have a protective effect in ischemic tissue. This is probably due to a decreased metabolic rate and therefore decreased energy requirements as shown by stable levels of lactate despite lower blood flow indicated by increasing ethanol ratio.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 141 86
        • Karolinska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • indication for knee arthroscopy due to suspected meniscus injury

Exclusion Criteria:

  • osteoarthritis or known systemic inflammatory disease, eg RA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: No Cooling and compression
Experimental: Intervention with cooling and compression
Device: Cooling and compression
Cooling and compression of the knee postoperatively with an Aircast device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2)

Secondary Outcome Measures

Outcome Measure
Subjective pain measurements (Visual analogue scale)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 23, 2010

First Submitted That Met QC Criteria

November 23, 2010

First Posted (Estimate)

November 24, 2010

Study Record Updates

Last Update Posted (Estimate)

November 24, 2010

Last Update Submitted That Met QC Criteria

November 23, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/59-31/4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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