Recruiting

Corticosteroid vs. Ketorolac

Sponsor:

St. Luke's Hospital, Pennsylvania

Code:

NCT02612272

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Ketorolac

Betamethasone

Study Details

Brief summary:

This study will compare the efficacy of intra-articular betamethasone injection to intra-articular ketorolac injection for symptomatic treatment of knee osteoarthritis in an equivalence study using a double-blinded, randomized, controlled design. Patients will be recruited from orthopaedic clinics at St. Luke's University Health Network. A total of 448 patients will be recruited (224 in each group) to receive an administration of an intra-articular betamethasone or ketorolac injection. The primary outcome is change in pain as assessed by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes include Knee Injury and Osteoarthritis Outcome (KOOS) and Knee Outcome Survey - Activities of Daily Living (KOS-ADL) scores and physical exam findings. Statistical analyses include repeated measures analysis of variance (ANOVA) (primary outcome) and selected ANOVA and nonparametric tests as deemed appropriate (secondary outcomes), with p < .05 denoting significance for all comparisons, and no adjustment for multiple testing.

Conditions

Knee Osteoarthritis

Study ID

NCT02612272

Start date

Nov, 2015

Status verified date

Oct, 2016

Completion date

Oct, 2017

Anticipated

Primary completion date

Oct, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Knee osteoarthritis as demonstrated on x-ray as Kellgren-Lawrence stage II or higher (Kellgren \& Lawrence, 1957)
  • Clinical symptoms and physical exam consistent with osteoarthritis

Exclusion Criteria:

  • Prior treatment with corticosteroid injections within the last 1 year
  • Failure of past treatment with corticosteroid injections
  • Medical treatment including oral medication, physical therapy, or other analgesia use within the last 20 days prior to injection
  • Pregnant
  • Under 18
  • Serious systemic disease
  • Gout arthropathy
  • Inflammatory joint disease including rheumatoid or psoriatic arthritis
  • Metabolic bone disease
  • Anserine bursitis or pain referred from other structures such as ipsilateral hip or lumbar spine
  • Patients with a significant effusion that requires aspiration

Study Design

Enrollment

448 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Corticosteroid

This arm will receive intra-articular betamethasone.

4cc of 1% lidocaine, 1cc of 0.9% normal saline and 1cc (6 mg) of betamethasone.

An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site

Please see detailed description of study for further information.

experimental: Ketorolac

This arm will receive intra articular ketorolac.

2cc (60 mg) of ketorolac and 4cc of 1% lidocaine

An 18 gauge needle connected to a syringe filled with the study drug will be administered. If there is no effusion, a 22 gauge needle with 6cc of the study drug will be injected into the administration site

Please see detailed description of study for further information.

Interventions

Ketorolac

intra-articular ketorolac

Betamethasone

intra-articular betamethasone

Primary outcome measure

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) [ Time Frame: Follow up at 1 month ]

Central Contacts and Locations

Central contacts

Paul Morton, MD

8082538696mortonp@slhn.org

Locations

St Luke's Health and University Network

Recruiting

Bethlehem, Pennsylvania, United States, 18018

Contacts

Manny Changalis, MS, CIP

484-526-4944manny.changalis@sluhn.org

Principal Investigator:

Gregory Carolan, MD

More Information

Sponsor

St. Luke's Hospital, Pennsylvania

Last update posted

Oct 13, 2016

Last verified

Oct, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Luke's Hospital, Pennsylvania on 2016-10-13.