Arthritis Clinical Trial
Official title:
Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Verified date | October 2012 |
Source | The Cleveland Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | June 2010 |
Est. primary completion date | April 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | The Cleveland Clinic | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
The Cleveland Clinic | Orthovita d/b/a Stryker |
United States,
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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Patients Managed With Blood Transfusion | daily during hospital stay (an expected average of 4 days) | Yes | |
Secondary | Total Calculated Hospital Blood Loss | daily during hospital stay (an expected average of 4 days) | Yes | |
Secondary | Preoperative & Postoperative Hemoglobin Values | within 30 days before surgery (preop), daily during hospital stay (an expected average of 4 days) | Yes | |
Secondary | Daily Narcotic Usage (Morphine-equivalent mg) | daily during hospital stay (an expected average of 4 days) | Yes | |
Secondary | Length of Stay | day of hospital discharge | Yes | |
Secondary | Pain Score Scale | A single scoring system used to evaluate overall pain on a scale of integers 0 to 10, with 0 representing "no pain" and 10 representing "unbearable pain." Thus, in this context, lower values represent better outcomes. | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery | Yes |
Secondary | Knee Injury and Osteoarthritis Outcome Score (KOOS) | A scoring system used to evaluate the patient's opinion about his/her knee and associated problems. Subscales include 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation (Sport/Rec), and 5) knee related quality of life (QOL). Standardized answer options are given (5 Likert boxes) and each question is assigned a score from 0 to 4. A normalized score between 0 to 100 is calculated for each subscale. Subscale scores are generally not combined; rather, they are reported separated. Higher values represent better outcomes (i.e., less extreme symptoms). | within 30 days before surgery (preop), 4 weeks after surgery, 12 weeks after surgery | Yes |
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