Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty
Parabens Flocculation on the Anti Inflammatory Effects of Corticosteroid Injections for Total Knee Arthroplasty
The purpose of this study is to identify whether corticosteroid use with anesthetics
 containing preservatives (parabens) reduces clinical effectiveness of the anti-inflammatory
 agent Up to 100 patients, both male and female, between the ages of 18-89 will be enrolled
 and randomized into either of the following groups; Group 1: These patients will receive a
 corticosteroid solution with lidocaine containing parabens.

 Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.
Corticosteroid injections have been used to treat inflammatory conditions for many decades
 (Storz 1973; Roszental, Zurakowski and Blazar 2008). In order to maximize the effectiveness
 on the synovial tissue, the concentrated form of corticosteroids is typically mixed with an
 anesthetic preparation. The corticosteroid suspension in a large volume of anesthetic can
 then disperse throughout the entire joint more effectively, especially in larger joints such
 as the knee (Centeno and Moore 1994). In addition, the anesthetic provides immediate relief
 to the area and can help verify that the injected site was the source of pain (Cole and
 Schumacher 2005). Typical preparations of anesthetic medications are sold in multi-use vials.
 The anesthetic solution usually contains a paraben preservative, except in the single vials
 used for spinal injections, because the use of paraben preservatives is contraindicated in
 spinal injections (Centeno and Moore 1994).

 Celestone and Kenalog are two corticosteroid products that are commonly used for
 intra-articular injections. If co-administration of a local anesthetic is desired, the
 suspension of Celestone or Kenalog is commonly mixed with 1% or 2% Lidocaine hydrochloride
 from multi-use vials containing parabens in Orthopedic and Rheumatology clinics.

 The orthopedic literature relating to injections rarely addresses the use of the anesthetic
 commonly used in injections. Flocculation occurs significantly when parabens are present, but
 the influence on the efficacy of the corticosteroid is unknown (Philipose et al. 2011; Hwang
 et al. 2016). There is abundant evidence that flocculation occurs when steroids are mixed
 with anesthetic solutions containing parabens however, the clinical significance of this
 phenomenon has not been reported. (Skedros and Pitts 2008b; Andreson, Deodhar and O'Rourke
 2005; Skedros and Pitts 2008; Lutt, O'Rouke and Deodhar 2007; Cole and Schumacher 2005).

 Cole and Schumacher (2005) suggest that flocculation can result from a chemical
 incompatibility between corticosteroid and other agents. Flocculation that occurs when
 corticosteroid is mixed with an anesthetic containing parabens may reduce the
 anti-inflammatory effect of the steroid. There are two possible mechanisms in which the
 corticosteroid preparation may be less effective. Flocculation may cause the corticosteroid
 to precipitate, thus reducing dispersal within the injected area (Centeno and Moore 1994).
 Additionally, flocculation may result from corticosteroid bonding with another molecule (such
 as methylparaben) within the anesthetic preparation, making it chemically less effective. The
 purpose of this study is to identify whether corticosteroid use with anesthetics containing
 parabens reduces clinical effectiveness relative to paraben-free preparations.

 STUDY DESIGN:

 OBJECTIVES:

 The purpose of this study is to identify whether corticosteroid use with anesthetics
 containing parabens reduces clinical effectiveness relative to para-free preparations.

 Hypothesis Alternate: Flocculation due to lidocaine containing parabens decreases the
 anti-inflammatory effects of corticosteroids when compared to paraben-free lidocaine.

 Procedure:

 The investigator will enroll up to 100 patients, both male and female, between the ages of
 18-89. Once the patient has been consented, They will be randomized into group 1 or group 2.
 The randomization is a 1 to 1 ratio. Subsequent follow-up via phone call will take place on
 week 1, week 2, week 4, week 8, and week 16.

 Group 1: These patients will receive a corticosteroid solution with lidocaine containing
 parabens.

 Group 2: These patients will receive corticosteroid solution with paraben free lidocaine.

 Corticosteroid injections will be given with or without ore-aspiration of synovial fluid.
 Patient will be in supine position with superior-lateral injection.

 Material identification: Celestone soluspan or Kenalog 1% 50mL multiuse vials without
 epinephrine, 1% 5mL lidocaine vials, 10mL syringes with 21mm x 1 ¼ inch needles, alcohol
 swabs, exam gloves, betadine solution.

 DATA COLLECTION:

 The investigator will collect the patients age, sex, BMI, Medical history, along with the
 WOMAC survey, which asks about the patients knee and activity level and VAS, pain sale (0-10)
 0 being the lease amount of pain and 10 being the worst.
Inclusion Criteria:

 -  Diagnosis of symptomatic primary knee osteoarthritis according to the American
 Rheumatism Association classification criteria for knee osteoarthritis, ability to
 understand study protocol and agreement to participate

 Exclusion Criteria:

 -  History of any knee injection in the past 6 months, History of more than 2 injections
 in the knee under study, previous fracture or surgical procedure of knee under
 investigation, any benign or malignant tumor in knee, chemotherapy, hemearthosis,
 current infection in the affected limb.