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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clinical Trial for Fibrin Sealant in Knee Surgery

NCT00440921

Total Knee-replacement Total Hip-replacement

WITHDRAWN NA

The Use of Fibrin Sealant to Reduce Bleeding After Total Knee Replacement

NCT01816282

Total Knee Replacement Primary Knee Arthroplasty Osteoarthritis of the Knee

COMPLETED NA

The Use of Evicel to Reduce Blood Loss in Total Knee Replacement Surgery

NCT01235715

Osteoarthritis

COMPLETED PHASE4

Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

NCT01656759

Osteoarthritis Intraoperative Bleeding

COMPLETED PHASE2/PHASE3

Efficacy and Safety of FLOSEAL for Hemostasis in Total Knee Arthroplasty

NCT01410240

Knee Replacement Surgery Osteoarthritis

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Blood Loss

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Fibrin Sealent

Group Type ACTIVE_COMPARATOR

Fibrin sealant

Intervention Type DRUG

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

Saline water

Group Type PLACEBO_COMPARATOR

Saline water

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Saline water

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Evicel, ATC-kode B02BC30

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.