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

November 23, 2010
November 23, 2010
January 2008
June 2010   (final data collection date for primary outcome measure)
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2) [ Designated as safety issue: No ]
Same as current
No Changes Posted
Subjective pain measurements (Visual analogue scale) [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
  • Knee Arthroscopy
  • Meniscus
  • Inflammation
  • Hydrops
  • Cooling
Device: Cooling and compression
Cooling and compression of the knee postoperatively with an Aircast device.
  • No Intervention: No Cooling and compression
  • Experimental: Intervention with cooling and compression
    Intervention: Device: Cooling and compression

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
June 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • indication for knee arthroscopy due to suspected meniscus injury

Exclusion Criteria:

  • osteoarthritis or known systemic inflammatory disease, eg RA
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01247376
2007/59-31/4
Yes
Dr Anders Stålman
Karolinska Institutet
Not Provided
Not Provided
Karolinska Institutet
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP