Evaluating a new device for amputees with transfemoral limb loss

A Prospective, Multicenter, Single-Arm, Open-Label Study to Evaluate the Safety and Effectiveness of the Transdermal Compress Device in Participants With Transfemoral Amputations

This study is testing a new device for people with leg amputations to see if it can improve their comfort and use of prosthetic limbs.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Balmoral Medical company (Industry-sponsored)
• Drugs / interventions: chemotherapy
• Locations: 9 sites (Sacramento, California and 8 other locations)
• Trial ID: NCT06134167 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the Transdermal Compress device in individuals with transfemoral amputations. It is a prospective, multicenter, single-arm, open-label study involving skeletally mature participants who have experienced limb loss and face challenges with conventional socket prostheses. Participants will undergo surgical implantation of the device and will be monitored for clinical assessments and prosthetic use over a period of up to five years. The study aims to track adverse events and device effects, as well as long-term outcomes through the Osseointegration Quality Registry.

Who should consider this trial

Good fit: Ideal candidates are skeletally mature individuals aged 18-65 with unilateral or bilateral transfemoral limb loss who cannot use conventional prostheses.

Not a fit: Patients with bone or vascular diseases or those who do not have adequate bone stock to support the implanted device may not benefit from this study.

Why it matters

Potential benefit: If successful, this device could significantly improve the quality of life for amputees by providing a more effective alternative to traditional prosthetic solutions.

How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving outcomes for amputees, suggesting potential for success.

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. 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

Where this trial is running

Sacramento, California and 8 other locations

• UC Davis Medical Center — Sacramento, California, United States (Recruiting)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
• Northwestern Memorial Hospital — Chicago, Illinois, United States (Recruiting)
• The Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
• Walter Reed Military Medical Center — Bethesda, Maryland, United States (Recruiting)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (Recruiting)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (Recruiting)
• Penn Medicine; University of Pennsylvania Health System — Philidelphia, Pennsylvania, United States (Recruiting)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (Recruiting)

Study contacts

• Study coordinator: Mary Thacker

Conditions Prosthesis and Implants