Trial Outcomes & Findings for Intraosseous Morphine in Primary TKA (NCT NCT04388111)

Results Overview

Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

65 participants

Primary outcome timeframe

14 days

Results posted on

2024-09-19

Participant Flow

Recruited at hospital from 5/5/2020 through 4/1/2021

Participant milestones

Participant milestones
Measure	Control Group Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Overall Study STARTED	33	32
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	9	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Group Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Overall Study Lost to Follow-up	5	3
Overall Study Adverse Event	1	1
Overall Study Protocol Violation	2	4
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Group n=24 Participants Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 Participants Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously	Total n=48 Participants Total of all reporting groups
Age, Continuous	65.06 years STANDARD_DEVIATION 6.37 • n=24 Participants	65.20 years STANDARD_DEVIATION 8.01 • n=24 Participants	65.13 years STANDARD_DEVIATION 7.16 • n=48 Participants
Sex: Female, Male Female	11 Participants n=24 Participants	15 Participants n=24 Participants	26 Participants n=48 Participants
Sex: Female, Male Male	13 Participants n=24 Participants	9 Participants n=24 Participants	22 Participants n=48 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	24 Participants n=24 Participants	24 Participants n=24 Participants	48 Participants n=48 Participants
Weight (kg)	96.03 KG STANDARD_DEVIATION 21.74 • n=24 Participants	88.13 KG STANDARD_DEVIATION 15.99 • n=24 Participants	92.08 KG STANDARD_DEVIATION 19.29 • n=48 Participants
BMI	30.58 KG/m^2 STANDARD_DEVIATION 3.89 • n=24 Participants	31.36 KG/m^2 STANDARD_DEVIATION 5.09 • n=24 Participants	30.97 KG/m^2 STANDARD_DEVIATION 4.50 • n=48 Participants

PRIMARY outcome

Timeframe: 14 days

Patient will fill out Visual Analog Scale pain scores three times a day for 14 days (day 1 as day of surgery) post-op in a pain journal. Levels will be compared between study groups. A higher score indicates a higher self-perceived level of pain and a lower score indicates a lower perceived level of pain for the patient. "0" representing no pain at all on the scale and "10" representing the highest pain imaginable. Scores are reported 3 times a day per day and averaged for that day. All of these scores were then averaged for the 14 day period and reported below.

Outcome measures

Outcome measures
Measure	Control Group n=24 Participants Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 Participants Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Post-operative Pain	4.29 visual analog pain scale Standard Deviation 0.39	3.57 visual analog pain scale Standard Deviation 0.37

SECONDARY outcome

Timeframe: preoperative

KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health.

Outcome measures

Outcome measures
Measure	Control Group n=24 Participants Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 Participants Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Pre-operative	52.0 KOOS Jr. Score Standard Error 2.0	51.4 KOOS Jr. Score Standard Error 2.1

SECONDARY outcome

Timeframe: two week postoperatively

KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported two-weeks post-operative.

Outcome measures

Outcome measures
Measure	Control Group n=24 Participants Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 Participants Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative	57.1 KOOS Jr. Score Standard Error 2.0	62.2 KOOS Jr. Score Standard Error 2.1

SECONDARY outcome

Timeframe: 8 weeks postoperatively

KOOS Jr Score patient reported outcome measure. Scale is from 0 to 100 with a 0 being total knee disability and 100 being perfect knee health. Reported 8 weeks post-operative.

Outcome measures

Outcome measures
Measure	Control Group n=24 Participants Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 Participants Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Knee Injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS Jr) Score - Two Weeks Postoperative	64.0 KOOS Jr. Score Standard Error 2.2	71.5 KOOS Jr. Score Standard Error 2.3

Adverse Events

Control Group

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Intarosseous Morphine

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Control Group n=24 participants at risk Patient receives an intraosseous injection of antibiotics into the tibia as per the standard of care for primary total knee arthroplasty under the study providers.	Intarosseous Morphine n=24 participants at risk Patient receives an intraosseous injection of antibiotics + 10mg of morphine into the tibia during their total knee arthroplasty. Morphine: 10mg of Morphine delivered Intraosseously
Blood and lymphatic system disorders Pulmonary Embolism	4.2% 1/24 • Number of events 1 • 1 year	4.2% 1/24 • Number of events 1 • 1 year

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

Houston Methodist Hospital

Phone: 346 238 1603

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place