Comparing Intra-articular Corticosteroid to Intra-articular Ketorolac Knee Injections

NCT02612272 | Unknown Phase 4

• 1 other identifier: SLHN 2015-40
• Study Type: interventional
• Target: 448
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Determination of patient's function and pain following intra-articular drug administration

  Follow up at 1 month

Secondary Outcomes (4)

• Knee injury and Osteoarthritis Outcome Score score

  Follow up at 1, 3 and 6 months

• Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL) scale

  Follow up at 1, 3 and 6 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Follow up at 3 months

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

  Follow up at 6 months

Study Arms (2)

Corticosteroid

ACTIVE COMPARATOR

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.

Drug: Betamethasone

Ketorolac

EXPERIMENTAL

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.

Drug: Ketorolac

Interventions

Ketorolac DRUG

intra-articular ketorolac

Also known as: toradol

Ketorolac

Betamethasone DRUG

intra-articular betamethasone

Also known as: Celestone

Corticosteroid

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St Luke's Health and University Network

Bethlehem, Pennsylvania, 18018, United States

RECRUITING

Related Publications (10)

• Calmet J, Esteve C, Boada S, Gine J. Analgesic effect of intra-articular ketorolac in knee arthroscopy: comparison of morphine and bupivacaine. Knee Surg Sports Traumatol Arthrosc. 2004 Nov;12(6):552-5. doi: 10.1007/s00167-003-0483-3. Epub 2004 Jun 9.

  PMID: 15197428 BACKGROUND

• Collins NJ, Misra D, Felson DT, Crossley KM, Roos EM. Measures of knee function: International Knee Documentation Committee (IKDC) Subjective Knee Evaluation Form, Knee Injury and Osteoarthritis Outcome Score (KOOS), Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Knee Outcome Survey Activities of Daily Living Scale (KOS-ADL), Lysholm Knee Scoring Scale, Oxford Knee Score (OKS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Activity Rating Scale (ARS), and Tegner Activity Score (TAS). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11(0 11):S208-28. doi: 10.1002/acr.20632. No abstract available.

  PMID: 22588746 BACKGROUND

• Karthikeyan S, Kwong HT, Upadhyay PK, Parsons N, Drew SJ, Griffin D. A double-blind randomised controlled study comparing subacromial injection of tenoxicam or methylprednisolone in patients with subacromial impingement. J Bone Joint Surg Br. 2010 Jan;92(1):77-82. doi: 10.1302/0301-620X.92B1.22137.

  PMID: 20044683 BACKGROUND

• KELLGREN JH, LAWRENCE JS. Radiological assessment of osteo-arthrosis. Ann Rheum Dis. 1957 Dec;16(4):494-502. doi: 10.1136/ard.16.4.494. No abstract available.

  PMID: 13498604 BACKGROUND

• Maricar N, Parkes MJ, Callaghan MJ, Felson DT, O'Neill TW. Where and how to inject the knee--a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):195-203. doi: 10.1016/j.semarthrit.2013.04.010.

  PMID: 24157093 BACKGROUND

• Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.

  PMID: 23177167 BACKGROUND

• Oztuna V, Eskandari M, Bugdayci R, Kuyurtar F. Intra-articular injection of tenoxicam in osteoarthritic knee joints with effusion. Orthopedics. 2007 Dec;30(12):1039-42. doi: 10.3928/01477447-20071201-07.

  PMID: 18198776 BACKGROUND

• Reuben SS, Connelly NR. Postoperative analgesia for outpatient arthroscopic knee sugery with intraarticular bupivacaine and ketorolac. Anesth Analg. 1995 Jun;80(6):1154-7. doi: 10.1097/00000539-199506000-00015.

  PMID: 7762844 BACKGROUND

• Stalman A, Tsai JA, Segerdahl M, Dungner E, Arner P, Fellander-Tsai L. Ketorolac but not morphine exerts inflammatory and metabolic effects in synovial membrane after knee arthroscopy: a double-blind randomized prospective study using the microdialysis technique. Reg Anesth Pain Med. 2009 Nov-Dec;34(6):557-64. doi: 10.1097/aap.0b013e3181bfbd9f.

  PMID: 19916211 BACKGROUND

• Unlu Z, Ay K, Tuzun C. Comparison of intra-articular tenoxicam and oral tenoxicam for pain and physical functioning in osteoarthritis of the knee. Clin Rheumatol. 2006 Feb;25(1):54-61. doi: 10.1007/s10067-005-1136-3. Epub 2005 Oct 15.

  PMID: 16228108 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ketorolac; Ketorolac Tromethamine; Betamethasone

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Gregory Carolan, MD

  St Luke's Health University Network

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul Morton, MD

CONTACT

8082538696; mortonp@slhn.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopaedic Surgery Resident

Study Record Dates

• First Submitted: September 9, 2015
• First Posted: November 23, 2015
• Study Start: November 1, 2015
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 13, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)