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Low enrollment
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| Name | Class |
|---|---|
| Orthopedic Research and Education Foundation | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ketorolac | Experimental | One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
|
| Corticosteroid | Active Comparator | One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
|
| Hyaluronic Acid | Active Comparator | One knee injection of Hylan G-F 20 (Synvisc-One) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketorolac Tromethamine Injection | Drug | One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Pain Scale (VAS) | average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection | 3 months post injection |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | self-reported pain, stiffness and functioning | 3 and 6 months post injection |
| Oxford Knee Questionnaire | self-reported pain, stiffness and functioning |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad J. Halawi, MD | UConn Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UConn Health | Farmington | Connecticut | 06032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15766999 | Background | 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. | |
| 16385518 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ketorolac | One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
| FG001 | Corticosteroid | One knee injection of 2 cc of methylprednisolone acetate (40mg/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 |
| FG002 | Hyaluronic Acid | One knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Only age, sex, race and ethnicity data available. No other analysis completed due to study termination.
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| ID | Title | Description |
|---|---|---|
| BG000 | Ketorolac | One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine Ketorolac Tromethamine Injection: One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Analogue Pain Scale (VAS) | average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection | 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. | Posted | 3 months post injection |
|
12 months
Same definition was used.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ketorolac | One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stomach ache | Gastrointestinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Outcomes, Research & Quality | UConn Health | 860-679-4932 | mcote@uchc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 25, 2019 | Sep 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D020911 | Ketorolac Tromethamine |
| D000077555 | Methylprednisolone Acetate |
| C049816 | hylan |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
| Methylprednisolone Acetate Injection | Drug | One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine |
|
|
| Hylan G-F 20 | Drug | One knee injection of Hylan G-F 20 (Synvisc-One) |
|
|
| 3 and 6 months post injection |
| Koos, Jr. Knee Survey | self-reported pain, stiffness and functioning | 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 | 6 months |
| Patient Satisfaction | satisfaction with treatment rated as "Yes" or "No" | 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 | 3 months post injection |
| Cost of Intervention | cost of each injection | 3 months post injection |
| Background | Bone and Joint Initiative: The Burden of Musculoskeletal Diseases in the United States. http://www.boneandjointburden.org/2014-report/ivh12/osteoarthritis-and-allied-disorders |
| 23996988 | 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. |
| 6345042 | Background | Gray RG, Gottlieb NL. Intra-articular corticosteroids. An updated assessment. Clin Orthop Relat Res. 1983 Jul-Aug;(177):235-63. |
| 25760356 | Background | 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. |
| 25548079 | Background | 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. |
| 25998016 | Background | 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. |
| 23194896 | Background | 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. |
| 23996989 | Background | 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. |
| 7762844 | Background | 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. |
| 19138855 | Background | 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. |
| 8689462 | Background | 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. |
| 1934686 | Background | 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. |
| 27402605 | Background | 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. |
| Corticosteroid |
One knee injection of 2 cc of methylprednisolone acetate (40mg/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 |
| BG002 | Hyaluronic Acid | One knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
One knee injection of 2 cc of methylprednisolone acetate (40mg/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
| OG002 | Hyaluronic Acid | One knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One) |
|
| Secondary | Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | self-reported pain, stiffness and functioning | 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. | Posted | 3 and 6 months post injection |
|
|
| Secondary | Oxford Knee Questionnaire | self-reported pain, stiffness and functioning | 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. | Posted | 3 and 6 months post injection |
|
|
| Secondary | Koos, Jr. Knee Survey | self-reported pain, stiffness and functioning | 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. | Posted | 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 | 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. | Posted | 6 months |
|
|
| Secondary | Patient Satisfaction | satisfaction with treatment rated as "Yes" or "No" | 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. | Posted | 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 | 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. | Posted | 3 months post injection |
|
|
| Secondary | Cost of Intervention | cost of each injection | 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. | Posted | 3 months post injection |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 1 |
| 4 |
| EG001 | Corticosteroid | One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Hyaluronic Acid | One knee injection of Hylan G-F 20 (Synvisc-One) | 0 | 6 | 0 | 6 | 0 | 6 |
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| D006571 | Heterocyclic Compounds |
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |