Trial Outcomes & Findings for Efficacy Study of an Unloading Brace for Knee Osteoarthritis (NCT NCT02150057)
NCT ID: NCT02150057
Last Updated: 2019-10-22
Results Overview
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
51 participants
Primary outcome timeframe
Baseline, 6 month follow-up
Results posted on
2019-10-22
Participant Flow
Participant milestones
| Measure |
Control Group
This group receives no experimental bracing intervention in the study.
|
Experimental Group
Breg Fusion Osteoarthritis knee unloading brace
Fusion Osteoarthritis Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
26
|
|
Overall Study
COMPLETED
|
19
|
22
|
|
Overall Study
NOT COMPLETED
|
6
|
4
|
Reasons for withdrawal
| Measure |
Control Group
This group receives no experimental bracing intervention in the study.
|
Experimental Group
Breg Fusion Osteoarthritis knee unloading brace
Fusion Osteoarthritis Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
Baseline Characteristics
Efficacy Study of an Unloading Brace for Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Control Group
n=19 Participants
This group receives no experimental bracing intervention in the study.
|
Experimental Group
n=22 Participants
This group is assigned to wear the BREG Fusion Osteoarthritis Unloading Brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
Total
n=41 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
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Continuous
|
64.13 years
STANDARD_DEVIATION 6.11 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 9.68 • n=7 Participants
|
65.9 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
22 participants
n=7 Participants
|
41 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 month follow-upPopulation: Only 19 patients in the control group completed the study. Only 22 patients in the experimental group completed the study.
The Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire will be administered to collect patient reported outcomes as they relate to pain, function, and quality of life. The pain scale range is 0-10 with lower scores indicating less pain.
Outcome measures
| Measure |
Control Group
n=19 Participants
This group receives no experimental bracing intervention in the study.
|
Experimental Group
n=22 Participants
This group will receive the BREG Fusion Osteoarthritis Knee Unloading Brace to wear for a determined amount of time per study protocol for the treatment of osteoarthritis pain.
BREG Fusion Unloading Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
|---|---|---|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
Baseline Visit
|
2.92 units on a scale
Standard Deviation 0.57
|
2.86 units on a scale
Standard Deviation 0.52
|
|
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
6 Month Visit
|
3.03 units on a scale
Standard Deviation 0.65
|
2.67 units on a scale
Standard Deviation 0.76
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Experimental Group
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group
n=19 participants at risk
This group receives no experimental bracing intervention in the study.
|
Experimental Group
n=22 participants at risk
Breg Fusion Osteoarthritis knee unloading brace
Fusion OA Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
|---|---|---|
|
Cardiac disorders
SOB/A-Fib
|
0.00%
0/19 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
4.5%
1/22 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
|
Nervous system disorders
Shingles
|
0.00%
0/19 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
4.5%
1/22 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
Other adverse events
| Measure |
Control Group
n=19 participants at risk
This group receives no experimental bracing intervention in the study.
|
Experimental Group
n=22 participants at risk
Breg Fusion Osteoarthritis knee unloading brace
Fusion OA Knee Brace: This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Rash
|
15.8%
3/19 • Number of events 3 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
9.1%
2/22 • Number of events 2 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
4.5%
1/22 • Number of events 1 • Patients were monitored for adverse events for the 6 month duration that they were enrolled in the study.
Our definition of adverse event does not differ from the clinicaltrials.gov definition.
|
Additional Information
Dr. Roger Ostrander
Andrews Institute for Orthopaedics & Sports Medicine
Phone: 850-916-3700
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place