Osteoarthritis
Conditions
Keywords
Osteoarthritis, Knee, Injection, Ketorolac
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).
Interventions
DRUGKetorolac Tromethamine Injection
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
DRUGHylan G-F 20
One knee injection of Hylan G-F 20 (Synvisc-One)
Sponsors
Orthopedic Research and Education Foundation
UConn Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Pain Scale (VAS) | 3 months post injection | average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxford Knee Questionnaire | 3 and 6 months post injection | self-reported pain, stiffness and functioning |
| Koos, Jr. Knee Survey | 3 and 6 months post injection | self-reported pain, stiffness and functioning |
| Visual Analogue Pain Scale (VAS) | 6 months | average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) | 3 and 6 months post injection | self-reported pain, stiffness and functioning |
| Non-routine Visits Due to Inadequate Pain Relief or Complications | 3 months post injection | Any additional visits due to inadequate pain relief or complications |
| Cost of Intervention | 3 months post injection | cost of each injection |
| Patient Satisfaction | 3 and 6 months post injection | satisfaction with treatment rated as Yes or No |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 8 |
| 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) | 6 |
| Total | 18 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study terminated | 4 | 8 | 4 |
Baseline characteristics
| Characteristic | Ketorolac | Corticosteroid | Hyaluronic Acid | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 4 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 3 Participants | 4 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 2 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 8 | 0 / 6 |
| other Total, other adverse events | 1 / 4 | 0 / 8 | 0 / 6 |
| serious Total, serious adverse events | 0 / 4 | 0 / 8 | 0 / 6 |
Outcome results
Primary
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
Population: 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.
Secondary
Cost of Intervention
cost of each injection
Time frame: 3 months post injection
Population: 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.
Secondary
Koos, Jr. Knee Survey
self-reported pain, stiffness and functioning
Time frame: 3 and 6 months post injection
Population: 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.
Secondary
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
Population: 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.
Secondary
Oxford Knee Questionnaire
self-reported pain, stiffness and functioning
Time frame: 3 and 6 months post injection
Population: 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.
Secondary
Patient Satisfaction
satisfaction with treatment rated as Yes or No
Time frame: 3 and 6 months post injection
Population: 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.
Secondary
Visual Analogue Pain Scale (VAS)
average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection
Time frame: 6 months
Population: 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.
Secondary
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
self-reported pain, stiffness and functioning
Time frame: 3 and 6 months post injection
Population: 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.