No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 60
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
100 (estimated)
Sponsor
Balmoral Medical company · Industry
Who this trial is looking for
This trial is looking for adults aged 18 to 60 who have lost a leg above the knee and have difficulty using traditional prosthetics. Participants will use a new device designed to help with mobility and will engage in follow-up evaluations and rehabilitation.
Are You a Good Fit for This Trial?
Rules you outSevere peripheral vascular diseaseDiabetes mellitusOsteomyelitisSevere metabolic disorders
You may be able to join if
I am between 18 and 60 years old.
I have lost my leg above the knee.
I have a body mass index (BMI) between 18.5 and 40.
I cannot use a conventional prosthesis or have problems with them.
I am willing and able to participate in follow-up evaluations.
I understand the purpose of the study and can give my consent.
You may not be able to join if
I am pregnant, nursing, or plan to become pregnant in the next year.
I have had an infection at my amputation site in the last 6 months.
I have a history of severe vascular disease or diabetes.
I have previously had a device implanted in my leg that is similar to the one in this study.
I have a history of severe metabolic disorders affecting my bones.
I currently smoke or have used tobacco in the last 6 months.
I have a condition that my doctor thinks would prevent me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria
1. 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.
2. Participant is a skeletally mature male or female and is 18 - 60 years of age at screening. Partic…
Inclusion Criteria
1. 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.
2. 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 conventional prosthesis.
3. Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
4. Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
5. 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.
6. Participant has adequate bone stock to support the implanted device
7. Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
8. 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.
Exclusion Criteria
1. Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
2. Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
3. Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
4. Participant has any distant foci of infections.
5. Participant has a history of sepsis within 6 months prior to Study Day 1.
6. Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
7. 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 unsound.
8. Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
9. 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).
10. Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
11. Participants with identified risk factors for osteoporosis must have a reported T-score \> -2.5 within 6 months prior to Study Day 1.
12. Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
13. Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
14. Participant has known drug or alcohol dependence currently or within the last year.
15. 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.
16. 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
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