Knee ArthroscopyNCT01247376
Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
A study testing Cooling and compression in people with Knee Arthroscopy and Meniscus, run by Karolinska Institutet at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Knee Arthroscopy, Meniscus, Inflammation
- What is being tested?
- Cooling and compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2008to Jun 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- indication for knee arthroscopy due to suspected meniscus injury
Who cannot join
- osteoarthritis or known systemic inflammatory disease, eg RA
Trial locations and contacts
1 site in 1 country.
About this study
Abstract
Background:
Read more
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
- Being tested
- Cooling and compression
- Keywords
- inflammation, arthroscopy, knee, microdialysis
- Medical subject headings
- Inflammation, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cooling and compressionDevice
Cooling and compression of the knee postoperatively with an Aircast device.
| Study group | Role | What they receive |
|---|---|---|
| No Cooling and compression | No intervention | Not described |
| Intervention with cooling and compression | Experimental | Not described Receives: Device: Cooling and compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2)
Secondary outcomes (1)
Subjective pain measurements (Visual analogue scale)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2008
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroscopyStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247376
- Sponsor's protocol ID
- 2007/59-31/4
- Status last verified
- Nov 2010
- First submitted
- 23 Nov 2010
- Last updated
- 24 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1055/s-0030-1248169.
PubMed 15915833Stalman 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.
PubMed 19916211Stalman 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.
PubMed 18442691Fellander-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.
PubMed 12463670
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temperature Sensitive Release of PGE2 and Diminished Energy Requirements in Synovial Tissue With Postoperative Cryotherapy - A Prospective Randomised Study After Knee Arthroscopy
- ClinicalTrials.gov ID
- NCT01247376
- Acronym / sponsor ID
- 2007/59-31/4
- Conditions
- Knee Arthroscopy, Meniscus, Inflammation, Hydrops, Cooling
- Keywords
- inflammation, arthroscopy, knee, microdialysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 24 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Cooling and compression | No intervention | – |
| Intervention with cooling and compression | Experimental | Device: Cooling and compression |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- indication for knee arthroscopy due to suspected meniscus injury
Key exclusion criteria (1 listed)
- osteoarthritis or known systemic inflammatory disease, eg RA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cooling and compressionCooling and compression of the knee postoperatively with an Aircast device. | Device | Intervention with cooling and compression |
Primary outcome
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2)
1 secondary outcome
Subjective pain measurements (Visual analogue scale)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2010.
- Background: PubMed 15915833Raynor 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.
- Background: PubMed 19916211Stalman 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.
- Background: PubMed 18442691Stalman 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.
- Background: PubMed 12463670Fellander-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cooling and compression in people with Knee Arthroscopy and Meniscus, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Synovial measurements of metabolic and inflammatory markers (glucose, lactate, glutamate, PGE2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01247376, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2010.