Trial Outcomes & Findings for Knee Injection RCT (NCT NCT03694821)

NCT ID: NCT03694821

Last Updated: 2020-02-18

Results Overview

average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

18 participants

Primary outcome timeframe

3 months post injection

Results posted on

2020-02-18

Participant Flow

Participant milestones

Participant milestones
Measure	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	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	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)
Overall Study STARTED	4	8	6
Overall Study COMPLETED	0	0	2
Overall Study NOT COMPLETED	4	8	4

Reasons for withdrawal

Reasons for withdrawal
Measure	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	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	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)
Overall Study Study terminated	4	8	4

Baseline Characteristics

Knee Injection RCT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ketorolac n=4 Participants 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	Corticosteroid n=8 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	Hyaluronic Acid n=6 Participants One knee injection of Hylan G-F 20 (Synvisc-One) Hylan G-F 20: One knee injection of Hylan G-F 20 (Synvisc-One)	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	14 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	7 Participants n=7 Participants	5 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	11 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants

PRIMARY outcome

Timeframe: 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.

average knee pain between 0 (no pain) and 10 (worst pain) 3 months following injection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

self-reported pain, stiffness and functioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

self-reported pain, stiffness and functioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

self-reported pain, stiffness and functioning

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

average knee pain between 0 (no pain) and 10 (worst pain) 6 months following injection

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

satisfaction with treatment rated as "Yes" or "No"

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Any additional visits due to inadequate pain relief or complications

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

cost of each injection

Outcome measures

Outcome data not reported

Adverse Events

Ketorolac

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Corticosteroid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hyaluronic Acid

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ketorolac n=4 participants at risk One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine	Corticosteroid n=8 participants at risk One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine	Hyaluronic Acid n=6 participants at risk One knee injection of Hylan G-F 20 (Synvisc-One)
Gastrointestinal disorders Stomach ache	25.0% 1/4 • Number of events 1 • 12 months Same definition was used.	0.00% 0/8 • 12 months Same definition was used.	0.00% 0/6 • 12 months Same definition was used.

Additional Information

Director of Outcomes, Research & Quality

UConn Health

Phone: 860-679-4932

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place