Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Status Completed

Clinical Trial Summary

Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Clinical Trial Description

Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.

Treatment group:

The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population:

The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met. ;

Study Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01656759
Study type	Interventional
Source	Rush University Medical Center
Contact
Status	Completed
Phase	Phase 2/Phase 3
Start date	May 2012
Completion date	August 2015

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04657926` - A Trial of APPA in the Treatment of Knee Osteoarthritis	Phase 2
Completed	`NCT02536833` - A Study Evaluating the Safety, Tolerability, and Efficacy of SM04690 Injected in the Target Knee Joint of Moderately to Severely Symptomatic Osteoarthritis Subjects	Phase 2
Completed	`NCT03014037` - Comparing Mesenchymal Stem Cell Counts in Unilateral vs. Bilateral Posterior Superior Iliac Spine Bone Marrow Aspiration	N/A
Recruiting	`NCT05937542` - A Qualitative Investigation of CLEAT Participants
Completed	`NCT03644615` - A Mindfulness Program (MBSR) in the Management of Symptomatic Hip and Knee Osteoarthritis	N/A
Recruiting	`NCT06061367` - Muscles Strength and Gait Parameteres After TKA
Withdrawn	`NCT04976972` - A Comparison of Patients Receiving a Total Knee Replacement With Robotic Assistance or With Conventional Instrumentation	N/A
Completed	`NCT05496205` - A SAD Study to Evaluate the Safety, Tolerability and PK/PD of iN1011-N17 in Healthy Volunteers	Phase 1
Completed	`NCT03850665` - Comparison of Functional Outcome in Patients After Hip Arthroplasty Depending on Surgical Approach	N/A
Completed	`NCT02826902` - Effect of Anesthesia on Quality of Recovery in Patients Undergoing Correctional Tibial Osteotomy - A Randomized Controlled Trial	N/A
Completed	`NCT04402502` - Dynamic 4DCT to Examine Wrist Carpal Mechanics	N/A
Completed	`NCT02923700` - Leukocyte-rich PRP vs Leukocyte-poor PRP for the Treatment of Knee Cartilage Degeneration: a Randomized Controlled Trial	Phase 4
Completed	`NCT04564053` - Study of Safety, Tolerability and Pharmacokinetics of LNA043 in Japanese Osteoarthritis Participants	Phase 1
Completed	`NCT05070871` - A Clinical Trial Investigating the Effect of Salmon Bone Meal on Osteoarthritis Among Men and Women	N/A
Not yet recruiting	`NCT05036174` - Diphenhydramine Ointment for Knee Osteoarthritis	N/A
Recruiting	`NCT02912429` - Onlay vs. Inlay Patellofemoral Arthroplasty	N/A
Recruiting	`NCT02666443` - Low Dose Dexamethasone in Supraclavicular Blocks	N/A
Active, not recruiting	`NCT02723929` - Effects of tDCS and tUS on Pain Perception in OA of the Knee
Withdrawn	`NCT02921594` - Kinematic Comparison of Vanguard XP and Vanguard CR Total Knee Arthroplasties	N/A
Terminated	`NCT02820766` - Journey II BCS CMS Total Knee System Compared to Other PS Total Knee Systems in PT Setting	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.