OsteoarthritisPhase 4NCT03694821

Knee Injection RCT

A Phase 4 study testing Ketorolac Tromethamine Injection, Methylprednisolone Acetate Injection and Hylan G-F 20 in people with Osteoarthritis, run by UConn Health at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Osteoarthritis
What is being tested?: Ketorolac Tromethamine Injection, Methylprednisolone Acetate Injection and Hylan G-F 20
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteUnited States
Study dates: 5 Jul 2018to 16 Jul 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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,

Show all 10Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

UConn Health
Farmington, Connecticut, 06032

Other trials in United States

About this study

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

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.

Read the 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).

Conditions: Osteoarthritis
Being tested: Ketorolac Tromethamine Injection, Methylprednisolone Acetate Injection, Hylan G-F 20
Keywords: Osteoarthritis, Knee, Injection, Ketorolac
Medical subject headings: Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ketorolac Tromethamine InjectionDrug
Also called Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Methylprednisolone Acetate InjectionDrug
Also called DEPO-MEDROL; NDC 0009-3073-01; J Code J1030
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Hylan G-F 20Drug
Also called Synvisc-One; NDC 58468-0090-03; J Code J7325
One knee injection of Hylan G-F 20 (Synvisc-One)

Study groups in NCT03694821
Study group	Role	What they receive
Ketorolac	Experimental	One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Receives: 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 Receives: Drug: Methylprednisolone Acetate Injection
Hyaluronic Acid	Active comparator	One knee injection of Hylan G-F 20 (Synvisc-One) Receives: Drug: Hylan G-F 20

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jul 201816 Jul 2019

First posted3 Oct 2018
Study start5 Jul 2018
Primary completion16 Jul 2019
Study completion16 Jul 2019

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (15)Papers the sponsor has linked to this study.
Other trials for OsteoarthritisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03694821
Sponsor's protocol ID: 18-093-1
Status last verified: Feb 2020
First submitted: 16 Aug 2018
Last updated: 18 Feb 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 15766999
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.
PubMed 16385518
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.
PubMed 23996988
Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63.
PubMed 6345042
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.
PubMed 25760356
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.
PubMed 25548079
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.
PubMed 25998016
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.
PubMed 23194896
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.
PubMed 23996989
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.
PubMed 7762844
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.
PubMed 19138855
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.
PubMed 8689462
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.
PubMed 1934686
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.
PubMed 27402605

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Osteoarthritis trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Cost-effectiveness of Intra-Articular Ketorolac Injection for Knee Osteoarthritis: A Randomized, Controlled, Double-Blinded Study
ClinicalTrials.gov ID: NCT03694821
Acronym / sponsor ID: 18-093-1
Conditions: Osteoarthritis
Keywords: Osteoarthritis, Knee, Injection, Ketorolac
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 18 participants (actual)
Lead sponsor: UConn HealthUniversity, hospital or other
Collaborators: Orthopedic Research and Education Foundation
Study start: 5 Jul 2018 (actual)
Primary completion: 16 Jul 2019 (actual)
Study completion: 16 Jul 2019 (actual)
First posted: 3 Oct 2018 (actual)
Results: Posted 18 Feb 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis: Ketorolac injection is a cost-effective adjunct in the nonoperative treatment of knee osteoarthritis (OA) compared to steroids and viscosupplementation.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
Ketorolac	Experimental	Drug: Ketorolac Tromethamine InjectionOne knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Corticosteroid	Active comparator	Drug: Methylprednisolone Acetate InjectionOne knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Hyaluronic Acid	Active comparator	Drug: Hylan G-F 20One knee injection of Hylan G-F 20 (Synvisc-One)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (10 listed)

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,

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ketorolac Tromethamine InjectionAlso: Ketorolac Tromethamine; NDC 63323-162-02; J Code J1885One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine	Drug	Ketorolac
Methylprednisolone Acetate InjectionAlso: DEPO-MEDROL; NDC 0009-3073-01; J Code J1030One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine	Drug	Corticosteroid
Hylan G-F 20Also: Synvisc-One; NDC 58468-0090-03; J Code J7325One knee injection of Hylan G-F 20 (Synvisc-One)	Drug	Hyaluronic Acid

Primary outcome

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

7 secondary outcomes

Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 3 and 6 months post injection
Oxford Knee Questionnaire
Time frame: 3 and 6 months post injection
Koos, Jr. Knee Survey
Time frame: 3 and 6 months post injection
Visual Analogue Pain Scale (VAS)
Time frame: 6 months
Patient Satisfaction
Time frame: 3 and 6 months post injection
Non-routine Visits Due to Inadequate Pain Relief or Complications
Time frame: 3 months post injection
Cost of Intervention
Time frame: 3 months post injection

Results and safety

Results posted to the registry on 18 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ketorolac	4	0
Corticosteroid	8	0
Hyaluronic Acid	6	2

Primary outcome: Visual Analogue Pain Scale (VAS)

Time frame: 3 months post injection

Population analysed: Data were collected, but the PI has left the institution. All efforts to locate and analyze the data have been exhausted; therefore no data are available to report.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ketorolac	0 of 4 (0%)	1 of 4 (25%)	0 of 4
Corticosteroid	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Hyaluronic Acid	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15766999Dieppe 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.
Background: PubMed 16385518Hootman 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.
BackgroundBone and Joint Initiative: The Burden of Musculoskeletal Diseases in the United States. http://www.boneandjointburden.org/2014-report/ivh12/osteoarthritis-and-allied-disorders
Background: PubMed 23996988Jevsevar 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.
Background: PubMed 6345042Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63.
Background: PubMed 25760356Hunter 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.
Background: PubMed 25548079van 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.
Background: PubMed 25998016Campbell 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.
Background: PubMed 23194896Berenbaum 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.
Background: PubMed 23996989Brown 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.
Background: PubMed 7762844Reuben 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.
Background: PubMed 19138855Desai 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mohamad J. Halawi, MD principal investigator

UConn Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac Tromethamine Injection, Methylprednisolone Acetate Injection and Hylan G-F 20 in people with Osteoarthritis, run by UConn Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analogue Pain Scale (VAS) (time frame: 3 months post injection). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03694821, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2020; AzTrials last refreshed its copy on 27 Oct 2026.