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

Tracking Information
First Received Date ^ICMJE	November 23, 2010
Last Updated Date	November 23, 2010
Start Date ^ICMJE	January 2008
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: November 23, 2010)	Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2) [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: November 23, 2010)	Subjective pain measurements (Visual analogue scale) [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Official Title ^ICMJE	Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
Condition ^ICMJE	Knee Arthroscopy Meniscus Inflammation Hydrops Cooling
Intervention ^ICMJE	Device: Cooling and compression Cooling and compression of the knee postoperatively with an Aircast device.
Study Arm (s)	No Intervention: No Cooling and compression Experimental: Intervention with cooling and compression Intervention: Device: Cooling and compression
Publications *	Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9. Review. Stålman A, Tsai JA, Segerdahl M, Dungner E, Arner P, Felländer-Tsai L. Ketorolac but not morphine exerts inflammatory and metabolic effects in synovial membrane after knee arthroscopy: a double-blind randomized prospective study using the microdialysis technique. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):557-64. Stålman A, Tsai JA, Wredmark T, Dungner E, Arner P, Felländer-Tsai L. Local inflammatory and metabolic response in the knee synovium after arthroscopy or arthroscopic anterior cruciate ligament reconstruction. Arthroscopy. 2008 May;24(5):579-84. doi: 10.1016/j.arthro.2007.12.010. Epub 2008 Feb 20. Felländer-Tsai L, Högberg E, Wredmark T, Arner P. In vivo physiological changes in the synovial membrane of the knee during reperfusion after arthroscopy. A study using the microdialysis technique. J Bone Joint Surg Br. 2002 Nov;84(8):1194-8.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	40
Completion Date	June 2010
Primary Completion Date	June 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: indication for knee arthroscopy due to suspected meniscus injury Exclusion Criteria: osteoarthritis or known systemic inflammatory disease, eg RA
Gender	Both
Ages	18 Years to 60 Years (Adult)
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ^ICMJE	Sweden
Removed Location Countries

Administrative Information
NCT Number ^ICMJE	NCT01247376
Other Study ID Numbers ^ICMJE	2007/59-31/4
Has Data Monitoring Committee	Yes
Plan to Share Data	Not Provided
IPD Description	Not Provided
Responsible Party	Dr Anders Stålman
Study Sponsor ^ICMJE	Karolinska Institutet
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Karolinska Institutet
Verification Date	November 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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