NCT01472913

Brief Summary

The purpose of this study is to measure the effect of fibrin sealant on reducing blood loss, pain and swelling when operated for bilateral total knee arthroplasty. Likewise the effect on Range Of Movement (ROM) and strength is examined.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2010

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 17, 2011

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

April 22, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

October 11, 2011

Last Update Submit

April 20, 2015

Conditions

Blood Loss

Keywords

Prospective randomised double-blind studyFibrin sealantBilateral simultaneous total knee arthroplastyBlood lossPostoperative painComplications

Outcome Measures

Primary Outcomes (1)

  • Blood loss

    24 hours postopertive blood loss estimated by drains from each of the knees .

    24 hours postoperative

Secondary Outcomes (4)

  • Pain

    2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.

  • swelling

    2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day

  • Range of Movement (ROM)

    2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day

  • Strength

    2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day

Study Arms (2)

Fibrin Sealent

ACTIVE COMPARATOR
Drug: Fibrin sealant

Saline water

PLACEBO COMPARATOR
Drug: Saline water

Interventions

Fibrin sealantDRUG

Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.

Also known as: Evicel, ATC-kode B02BC30
Fibrin Sealent
Saline waterDRUG

Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).

Saline water

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Elective bilateral knee arthroplasty
  • Must speak and understand Danish
  • Musk be able to gave oral and written consent.
  • Females must be post-menopausal, and last menstruation must be minimum of one year ago.

You may not qualify if:

  • Alcohol or medicine abuse
  • Treatment with opioids
  • Allergy to local anaesthetics
  • Allergy to active substances i fibrin sealant
  • Age below 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Denmark

Location

MeSH Terms

Conditions

HemorrhagePain, Postoperative

Interventions

Fibrin Tissue AdhesiveSaline Waters

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative ComplicationsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

FibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsEnvironmentEcological and Environmental PhenomenaBiological Phenomena

Study Officials

  • Christian Skovgaard Nielsen, M.D

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

  • Henrik Husted, M.D.

    Hvidovre University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. Orthopedic Surgery

Study Record Dates

First Submitted

October 11, 2011

First Posted

November 17, 2011

Study Start

August 1, 2010

Primary Completion

August 1, 2013

Study Completion

September 1, 2013

Last Updated

April 22, 2015

Record last verified: 2015-04

Locations

DK(1)