The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction
Primary Purpose
Anterior Cruciate Ligament Injuries
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction
Replica Knee Brace
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Injuries
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Germanium-Embedded Knee Brace
Replica Knee Brace
Arm Description
Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace
Following surgery the patients effected limb would be placed in a replica knee brace
Outcomes
Primary Outcome Measures
Short Form 36 (SF-36)
A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.
Secondary Outcome Measures
Pain Estimation
Visual Analog Scale
Leg Circumference
In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits
Knee Range of Motion
In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits
Full Information
NCT ID
NCT05068297
First Posted
September 19, 2021
Last Updated
October 21, 2021
Sponsor
Total Sports Medicine & Orthopedics
1. Study Identification
Unique Protocol Identification Number
NCT05068297
Brief Title
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction
Official Title
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Total Sports Medicine & Orthopedics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Germanium-Embedded Knee Brace
Arm Type
Experimental
Arm Description
Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace
Arm Title
Replica Knee Brace
Arm Type
Active Comparator
Arm Description
Following surgery the patients effected limb would be placed in a replica knee brace
Intervention Type
Other
Intervention Name(s)
Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction
Intervention Description
Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
Intervention Type
Other
Intervention Name(s)
Replica Knee Brace
Intervention Description
Replica Knee brace will be applied to the effected limb following ACL reconstruction
Primary Outcome Measure Information:
Title
Short Form 36 (SF-36)
Description
A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Pain Estimation
Description
Visual Analog Scale
Time Frame
6 weeks
Title
Leg Circumference
Description
In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits
Time Frame
6 weeks
Title
Knee Range of Motion
Description
In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shanthan C Challa, MD
Phone
7024998579
Email
shanthancchalla@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roddy McGee
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction
We'll reach out to this number within 24 hrs