Trial Outcomes & Findings for Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis (NCT NCT02576249)

Results Overview

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

29 participants

Primary outcome timeframe

3 months after the injection

Results posted on

2017-08-21

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine and Methylprednisolone 0.2% ropivacaine and methylprednisolone knee joint injection	Saline and Methylprednisolone 0.9% normal saline and methylprednisolone knee joint injection
Overall Study STARTED	15	14
Overall Study COMPLETED	15	14
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine and Methylprednisolone n=15 Participants 0.2% ropivacaine and methylprednisolone knee joint injection	Saline and Methylprednisolone n=14 Participants 0.9% normal saline and methylprednisolone knee joint injection	Total n=29 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 7.43 • n=5 Participants	57 years STANDARD_DEVIATION 11.8 • n=7 Participants	57 years STANDARD_DEVIATION 9.58 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Body Mass Index (BMI)	29.9 kg/m^2 STANDARD_DEVIATION 7.68 • n=5 Participants	30.9 kg/m^2 STANDARD_DEVIATION 6.46 • n=7 Participants	30.4 kg/m^2 STANDARD_DEVIATION 7.01 • n=5 Participants
Knee Effusion Yes	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Knee Effusion No	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months after the injection

The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Outcome measures

Outcome measures
Measure	Ropivacaine and Methylprednisolone n=15 Participants 0.2% ropivacaine and methylprednisolone knee joint injection	Saline and Methylprednisolone n=14 Participants 0.9% normal saline and methylprednisolone knee joint injection
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale	63.1 units on a scale Standard Deviation 16.1	67.2 units on a scale Standard Deviation 14.4

SECONDARY outcome

Timeframe: Pre-injection, immediately post-injection, 2 weeks, 3 months

Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.

Outcome measures

Outcome measures
Measure	Ropivacaine and Methylprednisolone n=15 Participants 0.2% ropivacaine and methylprednisolone knee joint injection	Saline and Methylprednisolone n=14 Participants 0.9% normal saline and methylprednisolone knee joint injection
Pain Scale Score 2 Weeks Activity	3.6 units on a scale Standard Deviation 2.5	3.6 units on a scale Standard Deviation 2
Pain Scale Score Pre-injection Activity	6.4 units on a scale Standard Deviation 2	5.8 units on a scale Standard Deviation 2.5
Pain Scale Score Pre-injection Rest	2.4 units on a scale Standard Deviation 2	4 units on a scale Standard Deviation 2
Pain Scale Score Immediately Post-injection Activity	1.9 units on a scale Standard Deviation 2.3	2.4 units on a scale Standard Deviation 2.2
Pain Scale Score Immediately Post-injection Rest	1.2 units on a scale Standard Deviation 1.5	1.4 units on a scale Standard Deviation 1.7
Pain Scale Score 2 Weeks Rest	1.7 units on a scale Standard Deviation 2	2.7 units on a scale Standard Deviation 2.2
Pain Scale Score 3 Months Activity	3.9 units on a scale Standard Deviation 2.7	4.6 units on a scale Standard Deviation 2.4
Pain Scale Score 3 Months Rest	2.6 units on a scale Standard Deviation 2.2	2.8 units on a scale Standard Deviation 2.4

SECONDARY outcome

Timeframe: baseline (pre-injection), 2 weeks, 3 months

The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury. A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score \>6 can only be achieved if the person participates in recreational or competitive sport.

Outcome measures

Outcome measures
Measure	Ropivacaine and Methylprednisolone n=15 Participants 0.2% ropivacaine and methylprednisolone knee joint injection	Saline and Methylprednisolone n=14 Participants 0.9% normal saline and methylprednisolone knee joint injection
Tegner Activity Level Scale baseline (pre-injection)	3.5 units on a scale Standard Deviation 2.2	3.0 units on a scale Standard Deviation 1.6
Tegner Activity Level Scale 2 weeks	4.3 units on a scale Standard Deviation 1.7	3.2 units on a scale Standard Deviation 1.3
Tegner Activity Level Scale 3 months	3.5 units on a scale Standard Deviation 2.1	3 units on a scale Standard Deviation 1.7

Adverse Events

Ropivacaine and Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Saline and Methylprednisolone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Jacob Sellon

Mayo Clinic

Phone: 507-255-1141

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place