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

Primary Purpose

Knee Arthroscopy, Meniscus, Inflammation

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cooling and compression
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Knee Arthroscopy focused on measuring inflammation, arthroscopy, knee, microdialysis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • indication for knee arthroscopy due to suspected meniscus injury

Exclusion Criteria:

  • osteoarthritis or known systemic inflammatory disease, eg RA

Sites / Locations

  • Karolinska University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

No Cooling and compression

Intervention with cooling and compression

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Subjective pain measurements (Visual analogue scale)

Full Information

First Posted
November 23, 2010
Last Updated
November 23, 2010
Sponsor
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT01247376
Brief Title
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Official Title
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Karolinska Institutet

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Arthroscopy, Meniscus, Inflammation, Hydrops, Cooling
Keywords
inflammation, arthroscopy, knee, microdialysis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No Cooling and compression
Arm Type
No Intervention
Arm Title
Intervention with cooling and compression
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Cooling and compression
Intervention Description
Cooling and compression of the knee postoperatively with an Aircast device.
Primary Outcome Measure Information:
Title
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2)
Secondary Outcome Measure Information:
Title
Subjective pain measurements (Visual analogue scale)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: indication for knee arthroscopy due to suspected meniscus injury Exclusion Criteria: osteoarthritis or known systemic inflammatory disease, eg RA
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
141 86
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
15915833
Citation
Raynor MC, Pietrobon R, Guller U, Higgins LD. Cryotherapy after ACL reconstruction: a meta-analysis. J Knee Surg. 2005 Apr;18(2):123-9. doi: 10.1055/s-0030-1248169.
Results Reference
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PubMed Identifier
19916211
Citation
Stalman A, Tsai JA, Segerdahl M, Dungner E, Arner P, Fellander-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. doi: 10.1097/aap.0b013e3181bfbd9f.
Results Reference
background
PubMed Identifier
18442691
Citation
Stalman A, Tsai JA, Wredmark T, Dungner E, Arner P, Fellander-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.
Results Reference
background
PubMed Identifier
12463670
Citation
Fellander-Tsai L, Hogberg 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. doi: 10.1302/0301-620x.84b8.13187.
Results Reference
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Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy

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