Transdermal Compress Device for Prosthesis Users

Recruiting at 10 trial locations

Overseen By Kristen Gault

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Balmoral Medical company

Must not be taking: Corticosteroids, Immunosuppressants, Chemotherapy, others

Disqualifiers: Pregnancy, Infection, Diabetes, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Transdermal Compress, designed for individuals with above-the-knee amputations who struggle with regular prosthetic sockets. Anchored to the bone, the device aims to offer a more comfortable and effective alternative for those unable to use traditional prostheses. The study seeks participants who have lost one or both legs above the knee and experience issues with their current prostheses or cannot use them at all. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking solution for prosthetic challenges.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on corticosteroids, immunosuppressive, or chemotherapy drugs, you may not be eligible to participate.

What prior data suggests that the Transdermal Compress device is safe for prosthesis users?

Research has shown that the Transdermal Compress Device, which attaches prosthetic limbs directly to the bone, is generally well-tolerated by patients. Studies have found that while minor issues are common, they are usually easy to manage. More serious problems occur less frequently and have decreased over time.

Initially developed for large joint replacements, this device has demonstrated a strong safety record in similar applications. The goal is to replace traditional socket prosthetics, which can be uncomfortable and less effective, potentially leading to a better experience for many users.

Joining this study offers the opportunity to help advance this promising technology, which could improve the lives of those with above-knee amputations. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Transdermal Compress Device is unique because it provides an innovative alternative for amputees who struggle with traditional socket prostheses. While most prosthetic devices rely on sockets that can be uncomfortable and limit mobility, this device is bone-anchored, eliminating the need for a socket entirely. Researchers are excited about this device because it offers improved stability and comfort, allowing users to move more naturally and without the irritation often caused by sockets. This new method could significantly enhance the quality of life for prosthesis users, providing a more secure and comfortable fit.

What evidence suggests that the Transdermal Compress device is effective for transfemoral amputations?

Research has shown that the Transdermal Compress device, which participants in this trial will receive, could be a breakthrough for people with above-knee amputations. Studies have found that this device allows the prosthetic leg to connect directly to the bone, eliminating the need for the usual socket. This connection can lead to better function and comfort for users. The technology behind this device, called osseointegration, securely attaches a metal implant to the body's skeleton. This often results in better movement and quality of life for amputees. Early findings suggest that many users experience improved stability and ease of use with this device. ^{1 2 3 5 6}

Who Is on the Research Team?

David Recker, M.D.

Principal Investigator

Balmoral

Are You a Good Fit for This Trial?

This trial is for men and women aged 18-65 with a BMI between 18.5 and ≤ 40 kg/m2, who have had one or both legs amputated above the knee without bone or vascular disease. They must struggle with conventional prostheses, have enough healthy bone for device support, not have specific bone defects, and commit to the study's full duration including rehabilitation.

Inclusion Criteria

My bones are strong enough to support an implant.

You don’t have any bone defects where the anchor plug is supposed to go.

I have lost one or both legs above the knee without any bone or blood vessel issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Implantation

Participants undergo surgical implantation of the Transdermal Compress device on Study Day 1

1 day

1 visit (in-person)

Rehabilitation and Monitoring

Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol. Participants will be assessed for effectiveness and safety endpoints at baseline and at Months 6, 12, 18, and 24 and annually through 5 years post-implantation.

5 years

Multiple visits (in-person) at Months 6, 12, 18, 24, and annually

Follow-up

Participants are monitored for safety and effectiveness after treatment, including long-term follow-up in the Osseointegration Quality Registry

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Transdermal Compress Device

Trial Overview The Transdermal Compress Device is being tested in this study to see if it's safe and effective for people with transfemoral (above-knee) amputations. The device aims to improve prosthesis use when traditional socket prostheses are problematic.

How Is the Trial Designed?

Group I: Transdermal Compress Device Experimental Treatment 1 Intervention

The Transdermal Compress device is a bone-anchored transdermal implant that addresses the shortcomings of a socket prosthesis and provides options to amputees who are not able to utilize a conventional socket prosthesis.

Transdermal Compress Device is already approved in United States, European Union for the following indications:

Approved in United States as Compress Device for:

• Transfemoral amputations due to trauma or cancer
• Rehabilitation problems with conventional socket prostheses

Approved in European Union as Compress Device for:

• Transfemoral amputations
• Rehabilitation problems with conventional socket prostheses

Who Is Running the Clinical Trial?

Balmoral Medical company

Lead Sponsor

Trials

4

Recruited

2,900+

Boston Biomedical Associates

Lead Sponsor

Trials

9

Recruited

340+

Published Research Related to This Trial

Transcutaneous osseointegration offers a promising alternative for amputees who cannot use conventional socket-based prostheses, allowing for a rigid attachment of the prosthetic limb to the residual bone, which can enhance function and patient satisfaction.

The Compress® device, originally designed for massive endoprostheses, has shown encouraging results when adapted for transcutaneous use in the U.S., and plans for a regulatory trial are underway to further evaluate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Compress® transcutaneous implant for rehabilitation following limb amputation. McGough, RL., Goodman, MA., Randall, RL., et al.[2022]

A new adjustable socket system for prosthetic users allows for incremental size adjustments during walking, which can help improve fit and comfort for individuals with trans-tibial limb loss.

In tests with 16 participants, the system demonstrated precise adjustments with minimal error (0.036 mm) and was well-received, as 11 out of 13 users felt comfortable making adjustments while walking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note. Sanders, JE., Garbini, JL., McLean, JB., et al.[2019]

A review of FDA databases revealed 120 unique adverse event reports related to Clinical Information Systems (CIS) from over 1.4 million total reports, highlighting issues like missing data and system downtime.

The findings suggest that while the number of reported adverse events is relatively low, there is a need for increased awareness and communication among manufacturers and users to improve the safety and effectiveness of CIS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases. Myers, RB., Jones, SL., Sittig, DF.[2022]

There is a significant gap in the safety evaluation of non-active implantable medical devices (NAIMDs) compared to medicines, particularly in the absence of a global program for collecting and analyzing adverse events and product quality issues.

Adopting methodologies from drug safety evaluations, such as utilizing real-world data sources like electronic health records and implementing unique device identifiers (UDI), could enhance the ongoing monitoring and assessment of NAIMD safety throughout their entire life cycle.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. Pane, J., Coloma, PM., Verhamme, KM., et al.[2018]

The Compress® device promotes bone ingrowth but requires special techniques for removal to preserve host bone, including relieving compressive forces and using specific tools for transfixation pins.

In a study of 63 patients, 11 underwent removal of the device, primarily due to infection, with most patients successfully ambulating post-surgery despite some requiring additional unplanned procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical technique: Methods for removing a Compress® compliant prestress implant. Abrams, GD., Gajendran, VK., Mohler, DG., et al.[2022]

The Compress implant provides immediate and stable fixation at the bone-implant interface by applying high compressive forces (400-800 lb), which helps prevent complications like aseptic loosening and osteolysis seen in traditional implants.

In a study of 12 patients with an average implantation duration of 3.3 years, no significant prosthetic failures were observed, and all retrieved specimens showed signs of viable bone growth, indicating positive biological effects of the implant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compressive osseointegration promotes viable bone at the endoprosthetic interface: retrieval study of Compress implants. Kramer, MJ., Tanner, BJ., Horvai, AE., et al.[2022]

The newly designed 'hybrid subischial socket' for transfemoral amputees effectively distributes pressure and shear stresses on the stump, ensuring that maximum pressures remain below pain thresholds, which enhances comfort and safety.

Finite element modeling confirmed that the socket's support areas align with optimal design principles, indicating that it provides safe and comfortable weight support while maintaining good functionality and user acceptance in real-world applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A finite element analysis of load distribution during donning and orthostatic posture in the ITOP hybrid subischial socket. Frigo, CA., Bellomo, S., Bigatti, M., et al.[2023]

The systematic review identified 69 publications that highlight essential features for developing a successful surgical registry, including the need for a steering committee, clear objectives, and strategic collaborations among stakeholders.

Key recommendations for registry development include planning for funding, establishing data processing systems, and ensuring patient involvement, which are crucial for monitoring the safety and effectiveness of surgically implanted hearing devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What are the essential features of a successful surgical registry? a systematic review. Mandavia, R., Knight, A., Phillips, J., et al.[2023]

The Italian Implantable Prostheses Registry (RIPI) is in the final stages of regulation, which will make data collection mandatory and enhance patient safety through better traceability and recall of prostheses.

The expertise from the Italian National Institute of Health in managing registries can serve as a model for improving data completeness and access in other medical device registries, both nationally and internationally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A far-reaching Regulation for the Italian National Registry of Implantable Prostheses: a possible model for other health registries. Toccaceli, V., Torre, M.[2021]

A study analyzing adverse event reports for cochlear implants found that most incidents involved patient injury (16,736 cases) and device malfunction (10,760 cases), highlighting areas for potential safety improvements.

Using machine learning algorithms, researchers achieved high prediction accuracy (up to 88.6%) in identifying the cochlear implant manufacturer and type of adverse event based on the descriptions, suggesting that data analysis can enhance understanding of device performance and safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. Crowson, MG., Hamour, A., Lin, V., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28275847/

The Compress® transcutaneous implant for rehabilitation ... The Compress device was developed as an alternate means of fixation for massive endoprostheses, such as distal femoral replacements.

2. withpower.com withpower.com/trial/phase-3-prosthesis-and-implants-11-2023-bff8f

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

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666769X2300009X

Osseointegration for amputees: Current state of direct ... Osseointegration is an evolving technique in amputee care which utilizes the integration of a metal implant with the appendicular skeleton.

4. researchgate.net researchgate.net/publication/314503908_The_CompressR_transcutaneous_implant_for_rehabilitation_following_limb_amputation

The Compress® transcutaneous implant for rehabilitation ... With this technology, the prosthetic limb can be rigidly attached to the residual bone, and the socket is eliminated, in many cases enabling improved function ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11892706/

A conceptual framework for soft tissue management of ... Recent reviews of outcomes in patients with transdermal, bone-anchored implants have highlighted these functional benefits while also ...

6. europepmc.org europepmc.org/article/med/28275847

The Compress® transcutaneous implant for rehabilitation ... With this technology, the prosthetic limb can be rigidly attached to the residual bone, and the socket is eliminated, in many cases enabling improved function ...