The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction

Study Overview
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Brief Summary
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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. ACL Reconstruction 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 ACL reconstruction. Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing ACL reconstruction. 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 ACL reconstruction. 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 ACL reconstruction. 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.

Official Title
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The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial

Conditions
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Anterior Cruciate Ligament Injuries

Intervention / Treatment
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* Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction
* Other: Replica Knee Brace


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-100 years old Male or female Compliant patient BMI less than 35 Undergoing ACL reconstruction within 30 days Exclusion Criteria: Rheumatoid Arthritis Poorly controlled diabetes (HgA1c > 7.5) Previous blood clots BMI greater than 35 Varicosities on operative leg

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Germanium-Embedded Knee Brace<br>Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace | Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction<br>* Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction<br>|
| Active Comparator: Replica Knee Brace<br>Following surgery the patients effected limb would be placed in a replica knee brace | Other: Replica Knee Brace<br>* Replica Knee brace will be applied to the effected limb following ACL reconstruction<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Estimation | Visual Analog Scale | 6 weeks | 
| Leg Circumference | In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits | 6 weeks | 
| Knee Range of Motion | In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits | 6 weeks |