Knee Injection RCT

Phase 4

Terminated

Interventions: Drug: Methylprednisolone Acetate Injection
Drug: Ketorolac Tromethamine Injection
Drug: Hylan G-F 20

Brief Summary: Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation.

Aims/objectives: The objective of this randomized, controlled, double-blinded, prospective study is to assess the efficacy and cost-effectiveness of knee injection with ketorolac in the nonsurgical management of symptomatic OA compared to injections with corticosteroids and viscosupplements.

Detailed Description: The purpose of this research study is to examine the effectiveness of intra-articular (inside the joint) ketorolac injection compared to injection with either corticosteroid or hyaluronic acid for the treatment of painful knee osteoarthritis. Patients will be randomly assigned to receive either ketorolac (a nonsteroidal anti-inflammatory drug, methylprednisolone (a steroid), hyaluronic acid (a substance that is naturally present in the human body).

Recruitment & Eligibility

Inclusion Criteria

Patients over the age of 18 who present with 1) symptomatic knee OA and radiographic evidence of joint space narrowing and 2) are interested in knee injections for pain relief.

Exclusion Criteria

Prior injections into the same knee within the past 6 months,
Pregnant and/or lactating women,
Inflammatory joint disease including rheumatoid or psoriatic arthritis,
Concurrent use of anti-rheumatic drugs,
Allergy or hypersensitivity to the study medications,
Patients on an active pain management contract,
Patients with insurance that requires pre-certification for any of the study drugs,
Inability to make own decisions regarding the informed consent,
Inability to read and/or understand English,
Patients who are unable to return for follow-up or be reached by phone.

Arm && Interventions

Group	Intervention	Description
Corticosteroid	Methylprednisolone Acetate Injection	One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Ketorolac	Ketorolac Tromethamine Injection	One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Hyaluronic Acid	Hylan G-F 20	One knee injection of Hylan G-F 20 (Synvisc-One)

Primary Outcome Measures

Name	Time	Method
Visual Analogue Pain Scale (VAS)	3 months post injection	average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	3 and 6 months post injection	self-reported pain, stiffness and functioning
Oxford Knee Questionnaire	3 and 6 months post injection	self-reported pain, stiffness and functioning
Koos, Jr. Knee Survey	3 and 6 months post injection	self-reported pain, stiffness and functioning
Visual Analogue Pain Scale (VAS)	6 months	average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
Patient Satisfaction	3 and 6 months post injection	satisfaction with treatment rated as "Yes" or "No"
Non-routine Visits Due to Inadequate Pain Relief or Complications	3 months post injection	Any additional visits due to inadequate pain relief or complications
Cost of Intervention	3 months post injection	cost of each injection