search
Back to results

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

Primary Purpose

Knee Arthroscopy, Knee Arthropathy Associated With Other Conditions

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Incrediwear Germanium-Embedded Knee Brace following Knee Arthroscopy
Replica Knee Brace
Sponsored by
Total Sports Medicine & Orthopedics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Arthroscopy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    October 7, 2021
    Last Updated
    October 21, 2021
    Sponsor
    Total Sports Medicine & Orthopedics
    Collaborators
    Incrediwear Holdings Inc
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05090670
    Brief Title
    The Impact of Germanium-Embedded Knee Brace on Patient Recovery After Knee Arthroscopy
    Official Title
    The Impact of Germanium-Embedded Knee Brace on Patient Recovery After Knee Arthroscopy: 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
    Collaborators
    Incrediwear Holdings Inc

    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. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Knee Arthroscopy, Knee Arthropathy Associated With Other Conditions

    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 Knee Arthroscopy
    Intervention Description
    Germanium-Embedded Knee Brace will be applied to the effected limb following Knee Arthroscopy
    Intervention Type
    Other
    Intervention Name(s)
    Replica Knee Brace
    Intervention Description
    Replica Knee brace will be applied to the effected limb following Knee Arthroscopy
    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, minimum is 0, maximum is 10 and median is 5
    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 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
    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 Knee Arthroscopy

    We'll reach out to this number within 24 hrs