Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Prospective Evaluation of Vitagel for Reduction in Blood Loss and Pain Following Unilateral Total Knee Arthroplasty
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. 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.


Options:
A: Arm Label: tranexamic acid - The G1 group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Acide Tranexamique | Arm Label: tranexamic acid - The G2 group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Acide Tranexamique | Intervention Type: DRUG; Name: Acide Tranexamique; Assigned to Arm(s): tranexamic acid - The G1 group, tranexamic acid - The G2 group
B: Arm Label: Peri-articular group; Type: EXPERIMENTAL; Interventions: Drug: Peri-articular tranexamic acid | Arm Label: Intravenous group; Type: ACTIVE_COMPARATOR; Interventions: Drug: Intravenous tranexamic acid | Intervention Type: DRUG; Name: Peri-articular tranexamic acid; Assigned to Arm(s): Peri-articular group | Intervention Type: DRUG; Name: Intravenous tranexamic acid; Assigned to Arm(s): Intravenous group
C: Arm Label: Topical tranexamic acid; Type: ACTIVE_COMPARATOR; Interventions: Drug: Topical tranexamic acid, Drug: Enoxaparin | Arm Label: Floseal®; Type: ACTIVE_COMPARATOR; Interventions: Drug: Floseal®, Drug: Enoxaparin | Arm Label: Control group; Type: PLACEBO_COMPARATOR; Interventions: Drug: Enoxaparin | Intervention Type: DRUG; Name: Topical tranexamic acid; Assigned to Arm(s): Topical tranexamic acid | Intervention Type: DRUG; Name: Floseal®; Assigned to Arm(s): Floseal® | Intervention Type: DRUG; Name: Enoxaparin; Assigned to Arm(s): Control group, Floseal®, Topical tranexamic acid
D: Arm Label: Vitagel; Type: EXPERIMENTAL; Interventions: Device: Vitagel | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DEVICE; Name: Vitagel; Assigned to Arm(s): Vitagel

Answer: D