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

Total Sports Medicine & Orthopedics

Status: Unknown

Conditions: Knee Arthropathy Associated With Other Conditions; Knee Arthroscopy

Treatments: Other: Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy; Other: Replica Knee Brace

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05090670

IW002

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Germanium-Embedded Knee Brace

Experimental group

Description:

Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace

Treatment:

Other: Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy

Replica Knee Brace

Active Comparator group

Description:

Following surgery the patients effected limb would be placed in a replica knee brace

Treatment:

Other: Replica Knee Brace