Ireland
--:--IST
Recruiting Not applicable

Transdermal Compress IDE Study

NCT06134167 · tracked via the Priya Life Science USA tracker
Sponsor
Balmoral Medical company
Phase
Not applicable
Started
2024-06-11
Last updated
2026-05-20

Condition(s) studied

Prosthesis and Implants

Investigational drug(s) / intervention(s)

Transdermal Compress Device

Transdermal Compress Device: Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1. Participants will be followed through the end of the study as they complete rehabilitation.

Study summary

The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.

Eligibility

Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • The study primary endpoint is a composite endpoint to determine the proportion of participants who are successful on the primary effectiveness and safety endpoints (overall success) at 2 years — Two (2) years post-implantation
    The following endpoint components will be used to assess effectiveness in the composite endpoint: Prosthetic Wear Time PROMIS Physical Function OPUS Satisfaction with Devices and Services The following will be used to assess safety in the composite endpoint: Lack of secondary surgical intervention. No more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation. Radiographic success.

Trial sites (9)

FacilityCityRegionStatus
UC Davis Medical Center Sacramento California Recruiting
University of Colorado Anschutz Medical Campus Aurora Colorado Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
The Johns Hopkins Hospital Baltimore Maryland Recruiting
Walter Reed National Military Medical Center Bethesda Maryland Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
The Ohio State University Wexner Medical Center Columbus Ohio Recruiting
Penn Medicine; University of Pennsylvania Health System Philidelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06134167 on ClinicalTrials.gov ↗ ← All trials in the USA