Anterior Cruciate Ligament InjuriesNCT05068297
The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction
A study testing Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction and Replica Knee Brace in people with Anterior Cruciate Ligament Injuries, run by Total Sports Medicine & Orthopedics.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anterior Cruciate Ligament Injuries
- What is being tested?
- Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction and Replica Knee Brace
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2021to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-100 years old
- Male or female
- Compliant patient
- BMI less than 35
- Undergoing ACL reconstruction within 30 days
Who cannot join
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Trial locations and contacts
No sites are listed yet.
Roddy McGee contact
About this study
Official title: The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial
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.
- Conditions
- Anterior Cruciate Ligament Injuries
- Being tested
- Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction, Replica Knee Brace
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incrediwear Germanium-Embedded Knee Brace following ACL reconstructionOther
Germanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction
Replica Knee BraceOther
Replica Knee brace will be applied to the effected limb following ACL reconstruction
| Study group | Role | What they receive |
|---|---|---|
| Germanium-Embedded Knee Brace | Experimental | Following surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace Receives: Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction |
| Replica Knee Brace | Active comparator | Following surgery the patients effected limb would be placed in a replica knee brace Receives: Other: Replica Knee Brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form 36 (SF-36)
A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.
Measured: 4 weeks
Secondary outcomes (3)
Pain Estimation
Visual Analog Scale
Measured: 6 weeks
Leg Circumference
In centimeters, measure by senior surgeon during physical exam using a tape measure at standard post-operative visits
Measured: 6 weeks
Knee Range of Motion
In degrees, measured by a senior surgeon using a Goniometer, at standard post-operative visits
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study startNov 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Total Sports Medicine & Orthopedics
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068297
- Sponsor's protocol ID
- IW001
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2021
- Last updated
- 25 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Germanium-Embedded Knee Brace on Patient Recovery After ACL Reconstruction: a Blinded and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05068297
- Acronym / sponsor ID
- IW001
- Conditions
- Anterior Cruciate Ligament Injuries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Total Sports Medicine & OrthopedicsUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Germanium-Embedded Knee Brace | Experimental | Other: Incrediwear Germanium-Embedded Knee Brace following ACL reconstructionFollowing surgery the patients effected limb would be placed in an Germanium-Embedded Knee Brace |
| Replica Knee Brace | Active comparator | Other: Replica Knee BraceFollowing surgery the patients effected limb would be placed in a replica knee brace |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-100 years old
- Male or female
- Compliant patient
- BMI less than 35
- Undergoing ACL reconstruction within 30 days
Key exclusion criteria (5 listed)
- Rheumatoid Arthritis
- Poorly controlled diabetes (HgA1c > 7.5)
- Previous blood clots
- BMI greater than 35
- Varicosities on operative leg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incrediwear Germanium-Embedded Knee Brace following ACL reconstructionGermanium-Embedded Knee Brace will be applied to the effected limb following ACL reconstruction | Other | Germanium-Embedded Knee Brace |
| Replica Knee BraceReplica Knee brace will be applied to the effected limb following ACL reconstruction | Other | Replica Knee Brace |
Primary outcome
Short Form 36 (SF-36)
Time frame: 4 weeks
A well-validated patient reported outcome and the most commonly used outcome instrument in orthopaedics.
3 secondary outcomes
Pain Estimation
Time frame: 6 weeks
Leg Circumference
Time frame: 6 weeks
Knee Range of Motion
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roddy McGee contact
Questions about this trial
What is this clinical trial studying?
A study testing Incrediwear Germanium-Embedded Knee Brace following ACL reconstruction and Replica Knee Brace in people with Anterior Cruciate Ligament Injuries, run by Total Sports Medicine & Orthopedics.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shanthan C Challa, MD (7024998579, shanthancchalla@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short Form 36 (SF-36) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.