Knee Injection RCT

Phase 4TerminatedNCT03694821

UConn Health18 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Osteoarthritis

Interventions

Ketorolac Tromethamine InjectionDRUG

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

Methylprednisolone Acetate InjectionDRUG

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

Hylan G-F 20DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

UConn Health

Farmington, Connecticut, United States

Outcomes

Primary Outcomes

Visual Analogue Pain Scale (VAS)

average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection

Time frame: 3 months post injection

Secondary Outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

self-reported pain, stiffness and functioning

Time frame: 3 and 6 months post injection

Oxford Knee Questionnaire

self-reported pain, stiffness and functioning

Time frame: 3 and 6 months post injection

Koos, Jr. Knee Survey

self-reported pain, stiffness and functioning

Time frame: 3 and 6 months post injection

Visual Analogue Pain Scale (VAS)

average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection

Time frame: 6 months

Patient Satisfaction

satisfaction with treatment rated as "Yes" or "No"

Time frame: 3 and 6 months post injection

Non-routine Visits Due to Inadequate Pain Relief or Complications

Any additional visits due to inadequate pain relief or complications

Time frame: 3 months post injection

Cost of Intervention

cost of each injection

Time frame: 3 months post injection

Data from ClinicalTrials.gov

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