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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anterior Cruciate Ligament Injuries
• Intervention / Treatment: Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction; Other: Replica Knee Brace

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Total Sports Medicine & Orthopedics

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): September 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: October 2, 2021
• First Posted (Actual): October 5, 2021

Study Record Updates

• Last Update Posted (Actual): October 25, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: IW001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No