Osteoarthritis of the Knee
Conditions
Keywords
knee osteoarthritis unicompartmental unloading brace
Brief summary
Subjects with symptomatic unicompartmental osteoarthritis of the knee will be invited to participate in this randomized study. Subjects will be assigned to either a Fusion Osteoarthritis Knee Brace group, or a control group that does not wear a brace. It is hypothesized that use of the Fusion Osteoarthritis Knee Brace will have a better outcome on osteoarthritis knee pain and quality of life compared to those who do not receive bracing intervention.
Detailed description
This investigation will recruit 72 subjects from the clinical population of the investigators with symptomatic unicompartmental osteoarthritis of the medial compartment of the knee who meet the inclusion criteria of the investigation. Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: 1. Fusion Osteoarthritis Knee Brace 2. No brace group Inclusion Criteria: * Age 30-80. * History of medial unicompartmental knee pain \> 3 months duration (medial compartment only). * Narrowing of medial joint space \< one half of lateral compartment * Varus deformity no greater than 80 * Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities. * Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries. * Manual dexterity sufficient to perform all tasks required of study participants. * Willingness to wear the brace a minimum of 4 hours per day. Exclusion Criteria: * Arthritides other than osteoarthritis. * Previous high tibial osteotomy of the affected knee. * Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy. * Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb. * Flexion limitation \> 20 degrees. * Significant soft tissue compromise preventing long-term brace use. * Peripheral vascular disease or other neurovascular complaints
Interventions
DEVICEBreg 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.
Sponsors
BREG, Inc
Andrews Research & Education Foundation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Caregiver)
Masking description
Two orthopedic surgeons will blindly grade the osteoarthritis and calculate the mechanical axis and knee angles. The two surgeons' measurements will be averaged. One surgeon's measurements will be repeated to determine intra-observer reliability.
Intervention model description
Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation: 1. Breg Fusion Osteoarthritis Knee Brace 2. No brace group Both groups will be allowed to continue standard conservative treatment of osteoarthritis including anti-inflammatory medications, home exercises and joint supplements.
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Age 30-80. * History of medial unicompartmental knee pain \> 3 months duration (medial compartment only). * Narrowing of medial joint space \< one half of lateral compartment * Varus deformity no greater than 80 * Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities. * Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries. * Manual dexterity sufficient to perform all tasks required of study participants. * Willingness to wear the brace a minimum of 4 hours per day.
Exclusion criteria
* Arthritides other than osteoarthritis. * Previous high tibial osteotomy of the affected knee. * Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy. * Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb. * Flexion limitation \> 20 degrees. * Significant soft tissue compromise preventing long-term brace use. * Peripheral vascular disease or other neurovascular complaints. * Leg-length discrepancy \> 2cm.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | Baseline, 6 month follow-up | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group This group receives no experimental bracing intervention in the study. | 19 |
| Experimental Group 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. | 22 |
| Total | 41 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 6 | 4 |
Baseline characteristics
| Characteristic | Experimental Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 11 Participants | 22 Participants |
| Age, Continuous | 67.8 years STANDARD_DEVIATION 9.68 | 64.13 years STANDARD_DEVIATION 6.11 | 65.9 years STANDARD_DEVIATION 8.12 |
| Region of Enrollment United States | 22 participants | 19 participants | 41 participants |
| Sex: Female, Male Female | 7 Participants | 8 Participants | 15 Participants |
| Sex: Female, Male Male | 15 Participants | 11 Participants | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 19 | 0 / 22 |
| other Total, other adverse events | 3 / 19 | 3 / 22 |
| serious Total, serious adverse events | 0 / 19 | 2 / 22 |
Outcome results
Primary
Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score
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.
Time frame: Baseline, 6 month follow-up
Population: Only 19 patients in the control group completed the study. Only 22 patients in the experimental group completed the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | Baseline Visit | 2.92 units on a scale | Standard Deviation 0.57 |
| Control Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | 6 Month Visit | 3.03 units on a scale | Standard Deviation 0.65 |
| Experimental Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | Baseline Visit | 2.86 units on a scale | Standard Deviation 0.52 |
| Experimental Group | Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain Score | 6 Month Visit | 2.67 units on a scale | Standard Deviation 0.76 |
p-value: <0.05ANOVA