An interventional study of Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction and Replica Knee Brace in Anterior Cruciate Ligament Injuries, sponsored by Total Sports Medicine & Orthopedics. Status unknown. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2021-10-25.
Sponsored by Total Sports Medicine & Orthopedics · Not applicable, Interventional, and Treatment
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.
512 studies on the registry are indexed under Anterior Cruciate Ligament Injuries; 164 are open to participants now.
This study's planned enrollment of 100 is above the median of 56 across 373 interventional studies indexed under Anterior Cruciate Ligament Injuries.
Browse Anterior Cruciate Ligament Injuries studies →Total Sports Medicine & Orthopedics is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace
Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction
Following surgery the patients effected limb would be placed in a replica knee brace
Other: Replica Knee Brace
Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
Replica Knee brace will be applied to the effected limb following ACL reconstruction
Short Form 36 (SF-36)
A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.
Time frame: 4 weeks
Pain Estimation
Visual Analog Scale
Time frame: 6 weeks
Leg Circumference
In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits
Time frame: 6 weeks
Knee Range of Motion
In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits
Time frame: 6 weeks
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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Anterior Cruciate Ligament Injuries→
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