Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty With Focus on Blood Loss, Pain, Swelling and Strength

April 20, 2015 updated by: Christian Skovgaard Nielsen, Hvidovre University Hospital

Fibrin Sealant in Bilateral Simultaneous Total Knee Arthroplasty. A Prospective Randomised Double-blinded Study Focus in on: Blood Loss, Pain, ROM, Swelling and Strength

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Hvidovre, Denmark
        • Hvidovre University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Saline water
Drug: Saline water
Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).
Active Comparator: Fibrin Sealent
Drug: Fibrin sealant
Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.
Other Names:
  • Evicel, ATC-kode B02BC30

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood loss
Time Frame: 24 hours postoperative
24 hours postopertive blood loss estimated by drains from each of the knees .
24 hours postoperative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain
Time Frame: 2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.

2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.

Measurement of postoperative pain is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
2-3 weeks before the operation and on 1st, 2nd, 3rd, 7th and 21st postoperative day.
swelling
Time Frame: 2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day

2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secundary outcomes by a physiotherapist.

Measurement of postoperative swelling is done on the 1st, 2nd and 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department. The swelling is measured as the difference of circumference 1 cm proximal of the patella 2-3 weeks before surgery and at the outlined postoperative times.
2-3 weeks before surgery and 1st, 2nd, 3rd, 7th and 21st postoperative day
Range of Movement (ROM)
Time Frame: 2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day

2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.

Measurement of postoperative ROM is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
2-3 weeks before surgery and on the 3rd, 7th and 21st postoperative day
Strength
Time Frame: 2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day

2-3 weeks before surgery the patients participate in an information meeting likewise the patients are tested for all secondary outcomes by a physiotherapist.

Measurement of postoperative strength is done on the 3rd day before mobilization. On the 7th and 21st postoperative day the majority of the patients are discharged and therefore testet at the outpatient department.
2-3 weeks before the operation and on the 3rd, 7th and 21st postoperative day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hvidovre University Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christian Skovgaard Nielsen, M.D, Hvidovre University Hospital
  • Principal Investigator: Henrik Husted, M.D., Hvidovre University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 11, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 16, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 17, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • H-A-2009-69

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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