Knee Injection RCT

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03694821
• Other study ID #: 18-093-1
• Status: Terminated
• Phase: Phase 4
• Start date: July 5, 2018
• Est. completion date: July 16, 2019

Study information

• Verified date: February 2020
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 16, 2019
• Est. primary completion date: July 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

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

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	Orthopedic Research and Education Foundation

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

Dieppe PA, Lohmander LS. Pathogenesis and management of pain in osteoarthritis. Lancet. 2005 Mar 12-18;365(9463):965-73. Review. — View Citation

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

Hootman JM, Helmick CG. Projections of US prevalence of arthritis and associated activity limitations. Arthritis Rheum. 2006 Jan;54(1):226-9. — View Citation

Hunter DJ. Viscosupplementation for osteoarthritis of the knee. N Engl J Med. 2015 Mar 12;372(11):1040-7. doi: 10.1056/NEJMct1215534. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

Reuben SS, Connelly NR. Postoperative analgesia for outpatient arthroscopic knee sugery with intraarticular bupivacaine and ketorolac. Anesth Analg. 1995 Jun;80(6):1154-7. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

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