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

NCT01247376 | Completed DMC

• 1 other identifier: 2007/59-31/4
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroscopy; Meniscus; Inflammation; Hydrops; Cooling

Keywords

inflammation; arthroscopy; knee; microdialysis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

• Subjective pain measurements (Visual analogue scale)

Study Arms (2)

No Cooling and compression

NO INTERVENTION

Intervention with cooling and compression

EXPERIMENTAL

Device: Cooling and compression

Interventions

Cooling and compression DEVICE

Cooling and compression of the knee postoperatively with an Aircast device.

Intervention with cooling and compression

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• indication for knee arthroscopy due to suspected meniscus injury

You may not qualify if:

• osteoarthritis or known systemic inflammatory disease, eg RA

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden, 141 86, Sweden

Location

Related Publications (4)

• 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.

  PMID: 15915833 BACKGROUND

• 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.

  PMID: 19916211 BACKGROUND

• 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.

  PMID: 18442691 BACKGROUND

• 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.

  PMID: 12463670 BACKGROUND

MeSH Terms

Conditions

Inflammation; Edema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2010
• First Posted: November 24, 2010
• Study Start: January 1, 2008
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 24, 2010

Record last verified: 2010-11

Locations

SE (1)