Knee Injection RCT

UConn Health

Status and phase: Terminated; Phase 4

Conditions: Osteoarthritis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03694821

18-093-1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 3 patient groups

Ketorolac

Experimental group

Description:

One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine

Treatment:

Drug: Ketorolac Tromethamine Injection

Corticosteroid

Active Comparator group

Description:

One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine

Treatment:

Drug: Methylprednisolone Acetate Injection

Hyaluronic Acid

Active Comparator group

Description:

One knee injection of Hylan G-F 20 (Synvisc-One)

Treatment:

Drug: Hylan G-F 20