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| Name | Class |
|---|---|
| INCREDIWEAR HOLDINGS, INC. | INDUSTRY |
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Anti-inflammatory brace technology has demonstrated superior clinical outcomes in the management of knee osteoarthritis and accelerate recovery time for Major League Soccer players. Authors have postulated that embedding germanium into cotton garments increases circulation and augments the inflammatory process through a transdermal micro-electromagnetic field. In addition to immunomodulatory effects, knee braces immobilize and stabilize the joint through tactile feedback from the skin. Thus, a germanium-embedded knee brace may provide inflammatory control to augment pain and edema while concomitantly enhancing proprioception. Knee Arthroscopy rehabilitation goals during the acute post-operative phase include diminishment of pain and edema as well as restoration of knee range-of-motion. The presented study intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy.
Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing Knee Arthroscopy. Patients will be randomized into germanium-infused knee brace group and compared to a replica knee brace group. Inclusion criteria will include skeletally mature individuals undergoing primary Knee Arthroscopy. Exclusion criteria will include autoimmune disorders and history of surgery on ipsilateral joint. The presented protocol intends to assess the impact of a germanium-embedded knee brace on patient recovery after Knee Arthroscopy. The primary outcome measure was chosen for its implications for the design and conduct of the study,1 including well-validated outcome instrument for comparison, facilitation of a priori power analysis, randomization, and blinding. Secondary outcomes were chosen for their pertinence to surgeon decision-making during patient rehabilitation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Germanium-Embedded Knee Brace | Experimental | Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace |
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| Replica Knee Brace | Active Comparator | Following surgery the patients effected limb would be placed in a replica knee brace |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy | Other | Germanium-Embedded Knee Brace will be applied to the effected limb following Knee Arthroscopy |
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| Measure | Description | Time Frame |
|---|---|---|
| Short Form 36 (SF-36) | A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics. | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Estimation | Visual Analog Scale, minimum is 0, maximum is 10 and median is 5 | 6 weeks |
| Leg Circumference | In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shanthan C Challa, MD | Contact | 7024998579 | shanthancchalla@gmail.com | |
| Roddy McGee | Contact |
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| Replica Knee Brace | Other | Replica Knee brace will be applied to the effected limb following Knee Arthroscopy |
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| 6 weeks |
| Knee Range of Motion | In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits | 6 weeks |