Transdermal Compress Device for Prosthesis Users

Recruiting at 9 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

Trial Summary

What is the purpose of this trial?

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

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.

Is the Transdermal Compress Device generally safe for humans?

The safety evaluation of non-active implantable medical devices, like the Transdermal Compress Device, faces challenges similar to those of medicines, but lacks a global program for collecting and analyzing adverse events. Efforts are being made to improve safety monitoring through initiatives like the unique device identifier (UDI) to better track long-term patient outcomes. ^{1 2 3 4 5}

How is the Transdermal Compress Device treatment different from other treatments for prosthesis users?

The Transdermal Compress Device is unique because it eliminates the need for a socket by rigidly attaching the prosthetic limb directly to the bone, promoting bone growth into the device for permanent integration. This approach can improve function and satisfaction for users who struggle with conventional socket-based prostheses. ^{6 7 8 9 10}

Research Team

David Recker, M.D.

Principal Investigator

Balmoral

Eligibility Criteria

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 am between 18 and 65 years old and my bones have fully grown.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Evaluating the Safety Profile of Non-Active Implantable Medical Devices Compared with Medicines. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Machine learning for pattern detection in cochlear implant FDA adverse event reports. [2021]

4. England pubmed.ncbi.nlm.nih.gov

What are the essential features of a successful surgical registry? a systematic review. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

The Compress® transcutaneous implant for rehabilitation following limb amputation. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Surgical technique: Methods for removing a Compress® compliant prestress implant. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Compressive osseointegration promotes viable bone at the endoprosthetic interface: retrieval study of Compress implants. [2022]

9. France pubmed.ncbi.nlm.nih.gov

A finite element analysis of load distribution during donning and orthostatic posture in the ITOP hybrid subischial socket. [2023]

10. England pubmed.ncbi.nlm.nih.gov

A motor-driven adjustable prosthetic socket operated using a mobile phone app: A technical note. [2019]