Phase 4
N=100
Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
Arthritis
Bottom Line
View on ClinicalTrials.gov: NCT01027286 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Nov 2012
Primary outcome: Primary: Number of Patients Managed With Blood Transfusion — 0; 5 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Vitagel (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Apr 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients Managed With Blood Transfusion |
0; 5 | — |
| SECONDARY Total Calculated Hospital Blood Loss |
1577; 1620 | — |
| SECONDARY Preoperative & Postoperative Hemoglobin Values |
13.8; 13.5; 11.9; 11.8; 10.5; 10.4 | — |
| SECONDARY Daily Narcotic Usage (Morphine-equivalent mg) |
42.7; 50.5; 69.1; 74.8; 58.6; 65.4 | — |
| SECONDARY Length of Stay |
3.3; 3.4 | — |
| SECONDARY Pain Score Scale |
5.5; 6.0; 2.6; 2.5; 1.9; 1.5 | — |
| SECONDARY Knee Injury and Osteoarthritis Outcome Score (KOOS) |
43.5; 39.9; 62.7; 57.1; 76.6; 75.5 | — |
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. 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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01027286). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.