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Knee Injection RCT

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ketorolac Tromethamine Injection
Methylprednisolone Acetate Injection
Hylan G-F 20
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, Knee, Injection, Ketorolac

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UConn Health

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

Ketorolac

Corticosteroid

Hyaluronic Acid

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 16, 2018
Last Updated
February 5, 2020
Sponsor
UConn Health
Collaborators
Orthopedic Research and Education Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03694821
Brief Title
Knee Injection RCT
Official Title
Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
July 5, 2018 (Actual)
Primary Completion Date
July 16, 2019 (Actual)
Study Completion Date
July 16, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UConn Health
Collaborators
Orthopedic Research and Education Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, Knee, Injection, Ketorolac

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketorolac
Arm Type
Experimental
Arm Description
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Arm Title
Corticosteroid
Arm Type
Active Comparator
Arm Description
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Arm Title
Hyaluronic Acid
Arm Type
Active Comparator
Arm Description
One knee injection of Hylan G-F 20 (Synvisc-One)
Intervention Type
Drug
Intervention Name(s)
Ketorolac Tromethamine Injection
Other Intervention Name(s)
Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885
Intervention Description
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone Acetate Injection
Other Intervention Name(s)
DEPO-MEDROL; NDC 0009-3073-01; J Code J1030
Intervention Description
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Intervention Type
Drug
Intervention Name(s)
Hylan G-F 20
Other Intervention Name(s)
Synvisc-One; NDC 58468-0090-03; J Code J7325
Intervention Description
One knee injection of Hylan G-F 20 (Synvisc-One)
Primary Outcome Measure Information:
Title
Visual Analogue Pain Scale (VAS)
Description
average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
Time Frame
3 months post injection
Secondary Outcome Measure Information:
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
self-reported pain, stiffness and functioning
Time Frame
3 and 6 months post injection
Title
Oxford Knee Questionnaire
Description
self-reported pain, stiffness and functioning
Time Frame
3 and 6 months post injection
Title
Koos, Jr. Knee Survey
Description
self-reported pain, stiffness and functioning
Time Frame
3 and 6 months post injection
Title
Visual Analogue Pain Scale (VAS)
Description
average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
Time Frame
6 months
Title
Patient Satisfaction
Description
satisfaction with treatment rated as "Yes" or "No"
Time Frame
3 and 6 months post injection
Title
Non-routine Visits Due to Inadequate Pain Relief or Complications
Description
Any additional visits due to inadequate pain relief or complications
Time Frame
3 months post injection
Title
Cost of Intervention
Description
cost of each injection
Time Frame
3 months post injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad J. Halawi, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15766999
Citation
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.
Results Reference
background
PubMed Identifier
16385518
Citation
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.
Results Reference
background
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
Results Reference
background
PubMed Identifier
23996988
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.
Results Reference
background
PubMed Identifier
6345042
Citation
Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63.
Results Reference
background
PubMed Identifier
25760356
Citation
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.
Results Reference
background
PubMed Identifier
25548079
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.
Results Reference
background
PubMed Identifier
25998016
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.
Results Reference
background
PubMed Identifier
23194896
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.
Results Reference
background
PubMed Identifier
23996989
Citation
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.
Results Reference
background
PubMed Identifier
7762844
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. doi: 10.1097/00000539-199506000-00015.
Results Reference
background
PubMed Identifier
19138855
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.
Results Reference
background
PubMed Identifier
8689462
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. doi: 10.1016/s1063-4584(05)80018-4.
Results Reference
background
PubMed Identifier
1934686
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.
Results Reference
background
PubMed Identifier
27402605
Citation
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.
Results Reference
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