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New treatment option for Prosthesis and Implants
Official title Transdermal Compress IDE Study
ClinicalTrials.gov ID: NCT06134167
What this study is testing
- What it's testing
- The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any...
- Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Participants \< 22 years of age require radiographic...
- Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
- Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
- Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a...
You likely can't join if
- Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
- Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
- Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
- Participant has any distant foci of infections.
- Participant has a history of sepsis within 6 months prior to Study Day 1.
- Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
See the full eligibility criteria
- Participant must be able to understand the investigational nature of this study and has reviewed and provided written, informed consent prior to any study-specific procedures.
- Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Participants \< 22 years of age require radiographic confirmation of skeletal maturity and must have failed the use of...
- Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
- Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
- Participant has problems with conventional prostheses or is not able to use a prosthesis at all or is anticipated to experience problems with a socket prosthesis in the investigator's judgment.
- Participant has adequate bone stock to support the implanted device
- Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
- Participant has the willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study including the prescribed rehabilitation program.
- Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
- Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
- Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
- Participant has any distant foci of infections.
- Participant has a history of sepsis within 6 months prior to Study Day 1.
- Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
- Participant has a femoral deformity that in the opinion of the treating surgeon results in an inability to properly insert the Transdermal Compress implant system, and/or results in alignment that is biomechanically...
- Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
- Participant has evidence of or history of severe peripheral vascular disease or insufficiency, muscular atrophy, neuromuscular disease, or diabetes mellitus (Type I or Type II).
- Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
- Participants with identified risk factors for osteoporosis must have a reported T-score \> -2.5 within 6 months prior to Study Day 1.
- Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
- Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
- Participant has known drug or alcohol dependence currently or within the last year.
- Participant is a smoker, nicotine, or tobacco user in any form or who has used nicotine or tobacco-containing products within the past 6 months prior to Study Day 1.
- Participant has any other condition, which in the opinion of the Investigator, precludes the participant's participation in the study or the participant is unlikely to comply with the protocol-defined
The study team makes the final eligibility decision.
Where it's taking place
- Sacramento, California, United States
- Aurora, Colorado, United States
- Chicago, Illinois, United States
- Baltimore, Maryland, United States
- Bethesda, Maryland, United States
- New York, New York, United States
- Columbus, Ohio, United States
- Philidelphia, Pennsylvania, United States
- Pittsburgh, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sacramento, California, United States; Aurora, Colorado, United States; Chicago, Illinois, United States; Baltimore, Maryland, United States; Bethesda, Maryland, United States; New York, New York, United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.