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

This study has been completed.
Sponsor:
Information provided by:
Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01247376
First received: November 23, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Knee Arthroscopy
Meniscus
Inflammation
Hydrops
Cooling
Device: Cooling and compression

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2) [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Subjective pain measurements (Visual analogue scale) [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: January 2008
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • indication for knee arthroscopy due to suspected meniscus injury

Exclusion Criteria:

  • osteoarthritis or known systemic inflammatory disease, eg RA
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01247376

Locations
Sweden
Karolinska University Hospital
Stockholm, Sweden, 141 86
Sponsors and Collaborators
Karolinska Institutet
  More Information

Publications:
Responsible Party: Dr Anders Stålman
ClinicalTrials.gov Identifier: NCT01247376     History of Changes
Other Study ID Numbers: 2007/59-31/4
Study First Received: November 23, 2010
Last Updated: November 23, 2010
Health Authority: Sweden: The National Board of Health and Welfare

Keywords provided by Karolinska Institutet:
inflammation
arthroscopy
knee
microdialysis

Additional relevant MeSH terms:
Edema
Inflammation
Signs and Symptoms
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014