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The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The Effect of a Novel Joint Distraction Knee Orthosis for Treating Medial Knee Osteoarthritis | Experimental | Patients experiencing unicompartment (medial or lateral) osteoarthritis will receive Icarus Adonis Joint Distraction brace. Patients will wear the brace for 12 weeks and document how often they wear the brace and their pain scores. Patients will fill out outcome surveys at 2, 4, 6, 8, and 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial joint distraction brace | Device | Patients will receive Icarus Adonis Joint Distraction brace. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Knee Injury and Osteoarthritis Outcome Score (KOOS) | Scored 0 to 100, where 0 represents total knee disability and 100 represents perfect knee | Baseline, 2, 4, 8, 12 weeks |
| European Quality of Life-5 Dimensions (EQ-5D-5L) | 0 to 1, where 1 is perfect health | Baseline, 2, 4, 8, 12 weeks. |
| Visual Analogue Scale (VAS) | 0-100, zero meaning no pain, 10 meaning severe pain | Baseline, 2, 4, 8, 12 weeks. |
| Functional Mobility Assessments | 6 minute walk test | Baseline, 2, 4, 8, 12 weeks |
| Functional Mobility Assessment | 5 times Sit to Stand test | Baseline, 2, 4, 8, 12 weeks |
| Functional Mobility Assessment | Timed Up and Go test | Baseline, 2, 4, 8, 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Benjamin M Koerber, PhD | Contact | 8147909364 | benk@icarusmedical.com | |
| Evan Eckersley | Contact | (570) 955-9662 | evan@icarusmedical.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icarus Medical Innovations | Charlottesville | Virginia | 22902 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38541761 | Background | Stetter BJ, Fiedler J, Arndt M, Stein T, Sell S. Impact of a Semi-Rigid Knee Orthotic Intervention on Pain, Physical Activity, and Functional Capacity in Patients with Medial Knee Osteoarthritis. J Clin Med. 2024 Mar 7;13(6):1535. doi: 10.3390/jcm13061535. | |
| 25499679 | Background | Cherian JJ, Bhave A, Kapadia BH, Starr R, McElroy MJ, Mont MA. Strength and Functional Improvement Using Pneumatic Brace with Extension Assist for End-Stage Knee Osteoarthritis: A Prospective, Randomized trial. J Arthroplasty. 2015 May;30(5):747-53. doi: 10.1016/j.arth.2014.11.036. Epub 2014 Nov 29. |
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IPD must be deidentified according to UVA IRB standard. If this would be the case then we would plan to share IPD and publish this study.
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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