A Phase 4 interventional study of Ketorolac Tromethamine Injection and Methylprednisolone Acetate Injection in Osteoarthritis, sponsored by UConn Health. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-02-18.
Sponsored by UConn Health · Phase 4, Interventional, and Treatment
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.
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).
4,445 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 18 is below the median of 70 across 3,474 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →UConn Health is the lead sponsor of 187 studies on the registry; 18 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Drug: Ketorolac Tromethamine Injection
One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
Drug: Methylprednisolone Acetate Injection
One knee injection of Hylan G-F 20 (Synvisc-One)
Drug: Hylan G-F 20
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
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
One knee injection of Hylan G-F 20 (Synvisc-One)
Also known as: Synvisc-One; NDC 58468-0090-03; J Code J7325
Visual Analogue Pain Scale (VAS)
average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
Time frame: 3 months post injection
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
self-reported pain, stiffness and functioning
Time frame: 3 and 6 months post injection
Oxford Knee Questionnaire
self-reported pain, stiffness and functioning
Time frame: 3 and 6 months post injection
Koos, Jr. Knee Survey
self-reported pain, stiffness and functioning
Time frame: 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
Time frame: 6 months
Patient Satisfaction
satisfaction with treatment rated as "Yes" or "No"
Time frame: 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
Time frame: 3 months post injection
Cost of Intervention
cost of each injection
Time frame: 3 months post injection
| Milestone | Ketorolac | Corticosteroid | Hyaluronic Acid |
|---|---|---|---|
| Started | 4 | 8 | 6 |
| Completed | 0 | 0 | 2 |
| Not completed | 4 | 8 | 4 |
| Withdrew: Study terminated | 4 | 8 | 4 |
average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection
No measurements were reported for this outcome.
self-reported pain, stiffness and functioning
No measurements were reported for this outcome.
self-reported pain, stiffness and functioning
No measurements were reported for this outcome.
self-reported pain, stiffness and functioning
No measurements were reported for this outcome.
average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
No measurements were reported for this outcome.
satisfaction with treatment rated as "Yes" or "No"
No measurements were reported for this outcome.
Any additional visits due to inadequate pain relief or complications
No measurements were reported for this outcome.
cost of each injection
No measurements were reported for this outcome.
Collected over 12 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ketorolac | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Corticosteroid | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| Hyaluronic Acid | 0/6 (0%) | 0/6 (0%) | 0/6 (0%) |
| Event | Ketorolac | Corticosteroid | Hyaluronic Acid |
|---|---|---|---|
| Stomach acheGastrointestinal disorders | 1/4 | 0/8 | 0/6 |
Only age, sex, race and ethnicity data available. No other analysis completed due to study termination.
| Age, Categorical(Participants) | Ketorolac | Corticosteroid | Hyaluronic Acid | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 6 | 4 | 14 |
| >=65 years | 0 | 2 | 2 | 4 |
| Sex: Female, Male(Participants) | Ketorolac | Corticosteroid | Hyaluronic Acid | Total |
|---|---|---|---|---|
| Female | 2 | 5 | 4 | 11 |
| Male | 2 | 3 | 2 | 7 |
| Ethnicity (NIH/OMB)(Participants) | Ketorolac | Corticosteroid | Hyaluronic Acid | Total |
|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 1 | 3 |
| Not Hispanic or Latino | 3 | 7 | 5 | 15 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Ketorolac | Corticosteroid | Hyaluronic Acid | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 3 | 1 | 4 |
| White | 3 | 4 | 4 | 11 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 1 | 1 | 3 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is terminated, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ketorolac Tromethamine