Trial Outcomes & Findings for Energy Dispersive Bracing for Conservative Treatment of Knee Osteoarthritis (NCT NCT02388646)

Results Overview

The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

Baseline and 3-month Visit

Results posted on

2021-04-12

Participant Flow

Participant milestones

Participant milestones
Measure	Exercise Only Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.	Brace Only Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.	Bracing + Exercises Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
Overall Study STARTED	20	20	20
Overall Study COMPLETED	16	19	14
Overall Study NOT COMPLETED	4	1	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Exercise Only n=16 Participants Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.	Brace Only n=19 Participants Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.	Bracing + Exercises n=14 Participants Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.	Total n=49 Participants Total of all reporting groups
Age, Continuous	67 years n=16 Participants	64 years n=19 Participants	66 years n=14 Participants	66 years n=49 Participants
Sex: Female, Male Female	7 Participants n=16 Participants	8 Participants n=19 Participants	6 Participants n=14 Participants	21 Participants n=49 Participants
Sex: Female, Male Male	9 Participants n=16 Participants	11 Participants n=19 Participants	8 Participants n=14 Participants	28 Participants n=49 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Laterality Right	8 Participants n=16 Participants	9 Participants n=19 Participants	7 Participants n=14 Participants	24 Participants n=49 Participants
Laterality Left	8 Participants n=16 Participants	10 Participants n=19 Participants	7 Participants n=14 Participants	25 Participants n=49 Participants

PRIMARY outcome

Timeframe: Baseline and 3-month Visit

Population: Change from baseline reported in table

The Visual Analog Scale (VAS) consists of a 100mm horizontal line with the words "No Pain" (score of 0) and "Pain as bad as it could possibly be" (score of 100) written on opposite ends. Participants will be asked to mark on the line where their pain is in relation to the two extremes. Measurement is taken from the left-hand side of the line to the mark and reported as a score out of 100. The difference between the baseline score and score at the 3-month study visit was compared between study arms.

Outcome measures

Outcome measures
Measure	Exercise Only n=16 Participants Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.	Brace Only n=19 Participants Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.	Bracing + Exercises n=14 Participants Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
Assessment of Pain Using the Visual Analog Scale Baseline Average VAS Pain Score	48.7 score on a scale Interval 4.0 to 97.0	62.6 score on a scale Interval 17.0 to 98.0	50.8 score on a scale Interval 2.0 to 92.0
Assessment of Pain Using the Visual Analog Scale 3-Month Average VAS Pain Score	27.1 score on a scale Interval 3.5 to 62.0	20.7 score on a scale Interval 1.0 to 48.0	13.2 score on a scale Interval 0.0 to 75.0

SECONDARY outcome

Timeframe: Baseline and 3-month Visit

Population: Normalized quadriceps force values reported in data table by study arm.

Change in quadriceps force is the difference between average quadriceps force measurements (in Newtons) obtained at the 3-month postoperative follow-up minus the average quadriceps force measurement at baseline. Averages are stratified by study arm. Negative values indicate a reduction in quadriceps force from baseline to 3-month.

Outcome measures

Outcome measures
Measure	Exercise Only n=16 Participants Home exercise program. Exercise Only: This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.	Brace Only n=19 Participants Reaction Web brace. Brace Only: This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.	Bracing + Exercises n=14 Participants Reaction Web brace and home exercises. Bracing + Exercises: This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
Change in Quadriceps Force	.25 Newtons (N) Interval -4.65 to 1.33	.15 Newtons (N) Interval -3.37 to 1.42	.31 Newtons (N) Interval -3.33 to 1.8

Adverse Events

Exercise Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Brace Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bracing + Exercises

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. Frank Kolisek

OrthoIndy

Phone: 3178845160

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place