Anterior Cruciate Ligament Injuries
Conditions
Brief summary
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.
Interventions
OTHERIncrediwear Germanium-Embedded Knee Brace following ACL reconstruction
Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
OTHERReplica Knee Brace
Replica Knee brace will be applied to the effected limb following ACL reconstruction
Sponsors
Total Sports Medicine & Orthopedics
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Short Form 36 (SF-36) | 4 weeks | A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Knee Range of Motion | 6 weeks | In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits |
| Pain Estimation | 6 weeks | Visual Analog Scale |
| Leg Circumference | 6 weeks | In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits |
Contacts
Primary ContactShanthan C Challa, MD
Backup ContactRoddy McGee
Outcome results
None listed