Knee Injection RCT

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.

Full Title of Study: “Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: July 16, 2019

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).

Interventions

  • Drug: Ketorolac Tromethamine Injection
    • One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
  • Drug: Methylprednisolone Acetate Injection
    • One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
  • Drug: Hylan G-F 20
    • One knee injection of Hylan G-F 20 (Synvisc-One)

Arms, Groups and Cohorts

  • Experimental: Ketorolac
    • One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
  • Active Comparator: Corticosteroid
    • One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
  • Active Comparator: Hyaluronic Acid
    • One knee injection of Hylan G-F 20 (Synvisc-One)

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • UConn Health
  • Collaborator
    • Orthopedic Research and Education Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mohamad J. Halawi, MD, Principal Investigator, UConn Health

References

Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. doi: 10.1016/S0140-6736(05)71086-2.

Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. doi: 10.1002/art.21562.

Bone and Joint Initiative: The Burden of Musculoskeletal Diseases in the United States. http://www.boneandjointburden.org/2014-report/ivh12/osteoarthritis-and-allied-disorders

Jevsevar DS. Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013 Sep;21(9):571-6. doi: 10.5435/JAAOS-21-09-571.

Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63.

Hunter DJ. Viscosupplementation for osteoarthritis of the knee. N Engl J Med. 2015 Mar 12;372(11):1040-7. doi: 10.1056/NEJMct1215534. No abstract available.

van der Weegen W, Wullems JA, Bos E, Noten H, van Drumpt RA. No difference between intra-articular injection of hyaluronic acid and placebo for mild to moderate knee osteoarthritis: a randomized, controlled, double-blind trial. J Arthroplasty. 2015 May;30(5):754-7. doi: 10.1016/j.arth.2014.12.012. Epub 2014 Dec 13.

Campbell KA, Erickson BJ, Saltzman BM, Mascarenhas R, Bach BR Jr, Cole BJ, Verma NN. Is Local Viscosupplementation Injection Clinically Superior to Other Therapies in the Treatment of Osteoarthritis of the Knee: A Systematic Review of Overlapping Meta-analyses. Arthroscopy. 2015 Oct;31(10):2036-45.e14. doi: 10.1016/j.arthro.2015.03.030. Epub 2015 May 19.

Berenbaum F. Osteoarthritis as an inflammatory disease (osteoarthritis is not osteoarthrosis!). Osteoarthritis Cartilage. 2013 Jan;21(1):16-21. doi: 10.1016/j.joca.2012.11.012. Epub 2012 Nov 27.

Brown GA. AAOS clinical practice guideline: treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013 Sep;21(9):577-9. doi: 10.5435/JAAOS-21-09-577. No abstract available.

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.

Desai A, Ramankutty S, Board T, Raut V. Does intraarticular steroid infiltration increase the rate of infection in subsequent total knee replacements? Knee. 2009 Aug;16(4):262-4. doi: 10.1016/j.knee.2008.12.002. Epub 2009 Jan 12.

Jones AC, Pattrick M, Doherty S, Doherty M. Intra-articular hyaluronic acid compared to intra-articular triamcinolone hexacetonide in inflammatory knee osteoarthritis. Osteoarthritis Cartilage. 1995 Dec;3(4):269-73. doi: 10.1016/s1063-4584(05)80018-4.

Leardini G, Mattara L, Franceschini M, Perbellini A. Intra-articular treatment of knee osteoarthritis. A comparative study between hyaluronic acid and 6-methyl prednisolone acetate. Clin Exp Rheumatol. 1991 Jul-Aug;9(4):375-81.

Bellamy JL, Goff BJ, Sayeed SA. Economic Impact of Ketorolac vs Corticosteroid Intra-Articular Knee Injections for Osteoarthritis: A Randomized, Double-Blind, Prospective Study. J Arthroplasty. 2016 Sep;31(9 Suppl):293-7. doi: 10.1016/j.arth.2016.05.015. Epub 2016 May 18.

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