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

Completed · Phase 4

Conditions studied: Arthritis

In brief

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. experimental group in which Vitagel® is used unilateral TKA 2. control group representing our current standard of care (no Vitagel®) A comparison of the functional and clinical results between these two groups will be conducted using several outcome measures including the KOOS, SF-12 version2 and pain scores through the previously IRB approved OrthoMidas registry. The primary variable of interest is blood loss, based on hemoglobin drop during the postoperative hospital stay. Of secondary interest will be; 1) pain levels in the PACU, 2) pain scores for all postoperative days, 3) average pain for the entire hospital stay, 4) length of stay, 5) patient satisfaction at discharge, 4 weeks postoperative, and 12 weeks postoperative, and 6) functional scores at 4 and 12 weeks postoperative.

Key facts

Study ID

NCT01027286

Run by

The Cleveland Clinic

People needed

108

Starts

2009-07-01

Expected to finish

2010-06-01

Last updated by the study team

2012-11-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• The Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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