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

Not Applicable

• Conditions: Anterior Cruciate Ligament Injuries
• Interventions: Other: Replica Knee Brace; Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction

• Registration Number: NCT05068297
• Lead Sponsor: Total Sports Medicine & Orthopedics

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-02
• Study First Posted: 2021-10-05
• Last Update Submitted: 2021-10-21
• Last Update Posted: 2021-10-25
• Study Start: 2021-11
• Primary Completion: 2022-09-01
• Study Completion: 2022-10-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Replica Knee Brace	Replica Knee Brace	Following surgery the patients effected limb would be placed in a replica knee brace
Germanium-Embedded Knee Brace	Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction	Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace

Primary Outcome Measures

Name	Time	Method
Short Form 36 (SF-36)	4 weeks	A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.

Secondary Outcome Measures

Name	Time	Method
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