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

Knee Arthroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05090670
• Other study ID #: IW002
• 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. Knee Arthroscopy 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 Knee Arthroscopy.

Single-center blinded randomized controlled clinical trial to study effectiveness of germanium-infused knee brace on rehabilitation in patient population undergoing Knee Arthroscopy. 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 Knee Arthroscopy. 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 Knee Arthroscopy. 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 Knee Arthroscopy 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

• Joint Diseases
• Knee Arthroscopy

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Total Sports Medicine & Orthopedics	Incrediwear Holdings Inc

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, minimum is 0, maximum is 10 and median is 5	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