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Clinical Trials/EUCTR2009-018245-21-DK
EUCTR2009-018245-21-DK
Active, not recruiting
Phase 1

Fibrinklæber ved bilateral knæalloplastik – et prospektivt randomiseret studie med fokus på: blodtab, smerte, ROM, hævelse og styrke - Fibrinklæber

Rigshospitalet0 sites48 target enrollmentJanuary 12, 2010
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DrugsEvicel, tidligere registreret som Quixil

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
Rigshospitalet
Enrollment
48
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 12, 2010
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Inklusionskriterier
  • •\- Patienter som skal have foretaget elektiv bilateral knæalloplastik.
  • •\- Skal kunne tale og forstå dansk
  • •\- Skal være i stand til at kunne give informeret mundtligt og skriftligt samtykke
  • •\- Kvindelige forsøgsdeltagere skal være posmenopausale med seneste menstruationsblødning minimum 1 år tidligere i forhold til operationsdagen
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) yes

Exclusion Criteria

  • •Eksklusionskriterier
  • •\- Alkohol\- og medicin misbrug
  • •\- Daglig behandling med opioider eller glukokortikoider.
  • •\- Allergi over for lokalanalgetika af amidtypen
  • •\- Morfin intolerance
  • •\- Alder \< 18 år
  • •\- Tilstande der potentielt influerer smerteperceptionen (diabetisk neuropati, reumatoid arthrit m.v.)
  • •\- Lateral release under operation på en af siderne

Outcomes

Primary Outcomes

Not specified

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