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

NCT ID: NCT05068297

Last Updated: 2021-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2022-10-01

Brief Summary

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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

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Conditions

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Anterior Cruciate Ligament Injuries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Germanium-Embedded Knee Brace

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

Group Type EXPERIMENTAL

Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction

Intervention Type OTHER

Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction

Replica Knee Brace

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

Group Type ACTIVE_COMPARATOR

Replica Knee Brace

Intervention Type OTHER

Replica Knee brace will be applied to the effected limb following ACL reconstruction

Interventions

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Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction

Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction

Intervention Type OTHER

Replica Knee Brace

Replica Knee brace will be applied to the effected limb following ACL reconstruction

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Total Sports Medicine & Orthopedics

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Shanthan C Challa, MD

Role: CONTACT

[email protected]
7024998579

Roddy McGee

Role: CONTACT

Other Identifiers

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IW001

Identifier Type: -

Identifier Source: org_study_id