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| Name | Class |
|---|---|
| BREG, Inc | INDUSTRY |
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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.
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:
Inclusion Criteria:
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | This group receives no experimental bracing intervention in the study. | |
| Experimental Group | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breg Fusion Unloading Brace | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 6 month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roger Ostrander, MD | Andrews Institute for Orthopaedics & Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Andrews Institute for Orthopaedics & Sports Medicine | Gulf Breeze | Florida | 32561 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 6232862 | Background | Cunningham LS, Kelsey JL. Epidemiology of musculoskeletal impairments and associated disability. Am J Public Health. 1984 Jun;74(6):574-9. doi: 10.2105/ajph.74.6.574. | |
| 9588729 | Background | Lawrence RC, Helmick CG, Arnett FC, Deyo RA, Felson DT, Giannini EH, Heyse SP, Hirsch R, Hochberg MC, Hunder GG, Liang MH, Pillemer SR, Steen VD, Wolfe F. Estimates of the prevalence of arthritis and selected musculoskeletal disorders in the United States. Arthritis Rheum. 1998 May;41(5):778-99. doi: 10.1002/1529-0131(199805)41:53.0.CO;2-V. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | This group receives no experimental bracing intervention in the study. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
25 patients were enrolled in the control group but only 19 completed the study. 26 patients were enrolled in the experimental group but only 22 completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | This group receives no experimental bracing intervention in the study. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Only 19 patients in the control group completed the study. Only 22 patients in the experimental group completed the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 6 month follow-up |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | This group receives no experimental bracing intervention in the study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| SOB/A-Fib | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment | Rash/blisters |
There was difficulty recruiting subjects for this study which lead to a small number of subjects analyzed. The results of this study should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Roger Ostrander | Andrews Institute for Orthopaedics & Sports Medicine | 850-916-3700 | 3725 | rostrander@flboneandjoint.com |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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Subjects who meet the recruitment conditions will be prospectively randomized into one of two treatment groups for 6 month evaluation:
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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.
|
| 7893781 | Background | Lethbridge-Cejku M, Tobin JD, Scott WW Jr, Reichle R, Plato CC, Hochberg MC. The relationship of age and gender to prevalence and pattern of radiographic changes of osteoarthritis of the knee: data from Caucasian participants in the Baltimore Longitudinal Study of Aging. Aging (Milano). 1994 Oct;6(5):353-7. doi: 10.1007/BF03324264. |
| 9101508 | Background | Gabriel SE, Crowson CS, Campion ME, O'Fallon WM. Direct medical costs unique to people with arthritis. J Rheumatol. 1997 Apr;24(4):719-25. |
| 7752127 | Background | Gabriel SE, Crowson CS, O'Fallon WM. Costs of osteoarthritis: estimates from a geographically defined population. J Rheumatol Suppl. 1995 Feb;43:23-5. |
| 10498556 | Background | Rao JK, Mihaliak K, Kroenke K, Bradley J, Tierney WM, Weinberger M. Use of complementary therapies for arthritis among patients of rheumatologists. Ann Intern Med. 1999 Sep 21;131(6):409-16. doi: 10.7326/0003-4819-131-6-199909210-00003. |
| 11302324 | Background | Buckwalter JA, Stanish WD, Rosier RN, Schenck RC Jr, Dennis DA, Coutts RD. The increasing need for nonoperative treatment of patients with osteoarthritis. Clin Orthop Relat Res. 2001 Apr;(385):36-45. doi: 10.1097/00003086-200104000-00008. |
| 9606092 | Background | Pollo FE. Bracing and heel wedging for unicompartmental osteoarthritis of the knee. Am J Knee Surg. 1998 Winter;11(1):47-50. No abstract available. |
| 12016084 | Background | Pollo FE, Otis JC, Backus SI, Warren RF, Wickiewicz TL. Reduction of medial compartment loads with valgus bracing of the osteoarthritic knee. Am J Sports Med. 2002 May-Jun;30(3):414-21. doi: 10.1177/03635465020300031801. |
| 9228878 | Background | Matsuno H, Kadowaki KM, Tsuji H. Generation II knee bracing for severe medial compartment osteoarthritis of the knee. Arch Phys Med Rehabil. 1997 Jul;78(7):745-9. doi: 10.1016/s0003-9993(97)90083-6. |
| 10225800 | Background | Kirkley A, Webster-Bogaert S, Litchfield R, Amendola A, MacDonald S, McCalden R, Fowler P. The effect of bracing on varus gonarthrosis. J Bone Joint Surg Am. 1999 Apr;81(4):539-48. doi: 10.2106/00004623-199904000-00012. |
| 10486029 | Background | Katsuragawa Y, Fukui N, Nakamura K. Change of bone mineral density with valgus knee bracing. Int Orthop. 1999;23(3):164-7. doi: 10.1007/s002640050337. |
| 15558372 | Background | Giori NJ. Load-shifting brace treatment for osteoarthritis of the knee: a minimum 2 1/2-year follow-up study. J Rehabil Res Dev. 2004 Mar;41(2):187-94. doi: 10.1682/jrrd.2004.02.0187. |
| 11041589 | Background | Draper ER, Cable JM, Sanchez-Ballester J, Hunt N, Robinson JR, Strachan RK. Improvement in function after valgus bracing of the knee. An analysis of gait symmetry. J Bone Joint Surg Br. 2000 Sep;82(7):1001-5. doi: 10.1302/0301-620x.82b7.10638. |
| 20086350 | Background | Divine JG, Hewett TE. Valgus bracing for degenerative knee osteoarthritis: relieving pain, improving gait, and increasing activity. Phys Sportsmed. 2005 Feb;33(2):40-6. doi: 10.3810/psm.2005.02.48. |
| 11285375 | Background | Birmingham TB, Kramer JF, Kirkley A, Inglis JT, Spaulding SJ, Vandervoort AA. Knee bracing for medial compartment osteoarthritis: effects on proprioception and postural control. Rheumatology (Oxford). 2001 Mar;40(3):285-9. doi: 10.1093/rheumatology/40.3.285. |
| 12180625 | Background | Barnes CL, Cawley PW, Hederman B. Effect of CounterForce brace on symptomatic relief in a group of patients with symptomatic unicompartmental osteoarthritis: a prospective 2-year investigation. Am J Orthop (Belle Mead NJ). 2002 Jul;31(7):396-401. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | 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.
|
|
|
| 0 |
| 19 |
| 0 |
| 19 |
| 3 |
| 19 |
| EG001 | Experimental Group | 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. | 0 | 22 | 2 | 22 | 3 | 22 |
| Shingles | Nervous system disorders | Systematic Assessment | Hospitalization for shingles |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D012216 |
| Rheumatic Diseases |