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

Anterior Cruciate Ligament Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05068297
• Other study ID #: IW001
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: October 2021
• Source: Total Sports Medicine & Orthopedics
• Contact: Shanthan C Challa, MD
• Phone: 7024998579
• Email: shanthancchalla[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: October 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Cruciate Ligament Injuries

Intervention

Other:
• Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction
Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
• Replica Knee Brace
Replica Knee brace will be applied to the effected limb following ACL reconstruction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Total Sports Medicine & Orthopedics

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short Form 36 (SF-36)	A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.	4 weeks
Secondary	Pain Estimation	Visual Analog Scale	6 weeks
Secondary	Leg Circumference	In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits	6 weeks
Secondary	Knee Range of Motion	In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits	6 weeks