NCT03694821

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 5, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 16, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 18, 2020

Completed
Last Updated

February 18, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

August 16, 2018

Results QC Date

October 1, 2019

Last Update Submit

February 5, 2020

Conditions

Osteoarthritis

Keywords

OsteoarthritisKneeInjectionKetorolac

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    3 and 6 months post injection

  • Oxford Knee Questionnaire

    3 and 6 months post injection

  • Koos, Jr. Knee Survey

    3 and 6 months post injection

  • Visual Analogue Pain Scale (VAS)

    6 months

  • Patient Satisfaction

    3 and 6 months post injection

  • +2 more secondary outcomes

Study Arms (3)

Ketorolac

EXPERIMENTAL

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

Drug: Ketorolac Tromethamine Injection

Corticosteroid

ACTIVE COMPARATOR

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

Drug: Methylprednisolone Acetate Injection

Hyaluronic Acid

ACTIVE COMPARATOR

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

Drug: Hylan G-F 20

Interventions

Ketorolac Tromethamine InjectionDRUG

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

Also known as: Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885
Ketorolac
Methylprednisolone Acetate InjectionDRUG

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

Also known as: DEPO-MEDROL; NDC 0009-3073-01; J Code J1030
Corticosteroid
Hylan G-F 20DRUG

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

Also known as: Synvisc-One; NDC 58468-0090-03; J Code J7325
Hyaluronic Acid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UConn Health

Farmington, Connecticut, 06032, United States

Location

Related Publications (15)

  • 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.

    PMID: 15766999BACKGROUND

  • 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.

    PMID: 16385518BACKGROUND

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

    BACKGROUND

  • 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.

    PMID: 23996988BACKGROUND

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

    PMID: 6345042BACKGROUND

  • 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.

    PMID: 25760356BACKGROUND

  • 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.

    PMID: 25548079BACKGROUND

  • 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.

    PMID: 25998016BACKGROUND

  • 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.

    PMID: 23194896BACKGROUND

  • 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.

    PMID: 23996989BACKGROUND

  • 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: 7762844BACKGROUND

  • 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.

    PMID: 19138855BACKGROUND

  • 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.

    PMID: 8689462BACKGROUND

  • 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.

    PMID: 1934686BACKGROUND

  • 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.

    PMID: 27402605BACKGROUND

MeSH Terms

Conditions

Osteoarthritis

Interventions

Ketorolac TromethamineMethylprednisolone Acetatehylan

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

IndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsMethylprednisolonePrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Director of Outcomes, Research & Quality
Organization
UConn Health
mcote@uchc.edu
860-679-4932

Study Officials

  • Mohamad J. Halawi, MD

    UConn Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

October 3, 2018

Study Start

July 5, 2018

Primary Completion

July 16, 2019

Study Completion

July 16, 2019

Last Updated

February 18, 2020

Results First Posted

February 18, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)