Clinical trial NCT05068297: The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction
Official title: The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anterior Cruciate Ligament Injuries
Lead sponsor: Total Sports Medicine & Orthopedics
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Short Form 36 (SF-36)
timeFrame: 4 weeks
Secondary outcomes:
measure: Pain Estimation
timeFrame: 6 weeks
measure: Leg Circumference
timeFrame: 6 weeks
measure: Knee Range of Motion
timeFrame: 6 weeks
Other outcomes:
Locations:
Study officials:
References: