Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty

NCT01027286 | Completed Phase 4 Results

• 1 other identifier: 09-548
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Vitagel® is an FDA approved class III medical device. It is a surgical hemostat, which has been shown to control bleeding during orthopaedic, cardiac, hepatic, and general surgical procedures. The product is a thrombin/collagen suspension which works in combination with the patient's own plasma to form a fibrin/collagen clot. The present prospective, randomized controlled trial is designed to evaluate the efficacy of Vitagel® for reducing blood loss and pain in patients managed with unilateral total knee arthroplasty (TKA). It is hypothesized that the use of Vitagel® may lead to less blood filled knees, and thus to a greater improvement in postoperative pain scores when compared to the control group. The two arms of the study will include:

1. 1.experimental group in which Vitagel® is used unilateral TKA
2. 2.control group representing our current standard of care (no Vitagel®)

Conditions

Arthritis

Outcome Measures

Primary Outcomes (1)

• Number of Patients Managed With Blood Transfusion

  daily during hospital stay (an expected average of 4 days)

Secondary Outcomes (6)

• Total Calculated Hospital Blood Loss

  daily during hospital stay (an expected average of 4 days)

• Preoperative & Postoperative Hemoglobin Values

  within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days)

• Daily Narcotic Usage (Morphine-equivalent mg)

  daily during hospital stay (an expected average of 4 days)

• Length of Stay

  day of hospital discharge

• Pain Score Scale

  within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery

Study Arms (2)

Vitagel

EXPERIMENTAL

Device: Vitagel

Control

NO INTERVENTION

No Vitagel used.

Interventions

Vitagel DEVICE

Vitagel applied just prior to closure during primary total knee arthroplasty

Vitagel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18 - 85 years
• Sex: Both male and female will be included. The male-to-female ratio will depend upon the patient population.
• Stable Health: At the time of surgery based on physical examination and medical history.
• Patient exhibited preoperative radiographic evidence of joint degeneration consistent with TKA that could not have been treated in non-operative fashion.
• Patient had severe knee pain and disability due to degenerative joint disease.
• Patient or patient's legal representative has signed the Informed Consent form. The patient is capable of making informed decisions regarding his/her healthcare.

You may not qualify if:

• Patients with history of liver disease. Patients with liver dysfunction from cirrhosis or hepatitis may have impaired production of factors in the clotting cascade which may make these individuals more prone to bleed, especially with the use of anticoagulants. For this reason, these patients will also be excluded from this study if a baseline INR if greater than 1.3.
• Patients allergic to materials of bovine origin.
• Patients predonating autologous blood.
• Patients with a preoperative platelet count of less than 100,000.
• Patients undergoing bilateral or revision surgery.
• Evidence of bleeding or metabolic - based hemolytic disorder (hemophilia or anticoagulation use), or hypercoaguable disorder.
• Previous history of infection in the affected joint.
• Peripheral vascular disease.
• Patient was a poor compliance risk - treated for ethanol or drug abuse, physical or mental handicap, etc.
• Patients with a previous history of venous thromboembolism, or other reason for requiring anticoagulation other than ASA 325 mg po BID and mechanical compression.

Sponsors & Collaborators

• The Cleveland Clinic: lead
• Orthovita d/b/a Stryker: collaborator

Study Sites (1)

The Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• Bloomfield MR, Klika AK, Molloy RM, Froimson MI, Krebs VE, Barsoum WK. Prospective randomized evaluation of a collagen/thrombin and autologous platelet hemostatic agent during total knee arthroplasty. J Arthroplasty. 2012 May;27(5):695-702. doi: 10.1016/j.arth.2011.09.014. Epub 2011 Oct 27.

  PMID: 22035976 RESULT

MeSH Terms

Conditions

Arthritis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Wael K Barsoum, MD
• Organization: The Cleveland Clinic

barsouw@ccf.org

216-444-7515

Study Officials

• Wael K Barsoum, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2009
• First Posted: December 7, 2009
• Study Start: July 1, 2009
• Primary Completion: April 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 29, 2012
• Results First Posted: November 29, 2012

Record last verified: 2012-10

Locations

US (1)