A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants With Transfemoral Amputations

NCT06134167 | Recruiting Phase 3 DMC FDA Device

• 1 other identifier: BAL-448-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Prosthesis and Implants

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  Two (2) years post-implantation

Secondary Outcomes (12)

• Overall infection rate

  Two (2) and Five (5) years post-implantation

• Lack of secondary surgical intervention

  Two (2) and Five (5) years post-implantation

• Orthotics and Prosthetics Users Survey: Satisfaction with Devices

  Two and Five (2-5) years post-implantation

• Prosthetic Wear Time

  Two (2) and Five (5) years post-implantation

• Patient Reported Outcome Measurement Information System: Physical Function

  Two (2) and Five (5) years post-implantation

Other Outcomes (1)

• Radiographic Outcomes

  Two (2) and Five (5) years post-implantation

Study Arms (1)

Transdermal Compress Device

EXPERIMENTAL

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.

Device: Transdermal Compress Device

Interventions

Transdermal Compress Device 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.

Transdermal Compress Device

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.
• Participant has an estimated BMI of ≥ 18.5 and ≤ 40 kg/m2 and weight ≤ 245 lbs without prosthesis.
• Participant has unilateral or bilateral transfemoral limb loss without bone or vascular disease.
• 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.
• Participant has adequate bone stock to support the implanted device
• Participant does not have any cortical defect located between the expected location of the anchor plug and spindle/bone interface.
• 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.

You may not qualify if:

• Female participants who are pregnant, nursing, or have a planned pregnancy during the first 12 months post-surgical implantation.
• Participant had a prior osseointegrated device implanted in the lower limb planned for the study device.
• Participant has a history of systemic or localized infection at the residual limb site within 6 months prior to Study Day 1.
• Participant has any distant foci of infections.
• Participant has a history of sepsis within 6 months prior to Study Day 1.
• Participant's length of the residual femur cannot accommodate the intramedullary portion of the Transdermal Compress device.
• 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.
• Participant does not have an adequate myofascial flap to allow for circumferential contact with the implanted device.
• 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).
• Participant has evidence of or a documented history of osteomyelitis (excluding the history of osteomyelitis distal to amputation), systemic osteoporosis, or osteomalacia.
• Participants with identified risk factors for osteoporosis must have a reported T-score \> -2.5 within 6 months prior to Study Day 1.
• Participant has evidence of or a documented history of severe metabolic disorders that may impair bone formation.
• Participant has a history of systemically administered corticosteroids or immunosuppressive or immunomodulatory therapy or chemotherapy drugs.
• Participant has known drug or alcohol dependence currently or within the last year.
• 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.

Sponsors & Collaborators

• Balmoral Medical company: lead

Study Sites (9)

UC Davis Medical Center

Sacramento, California, 95817, United States

RECRUITING

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

RECRUITING

Walter Reed Military Medical Center

Bethesda, Maryland, 20889, United States

RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

RECRUITING

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Penn Medicine; University of Pennsylvania Health System

Philidelphia, Pennsylvania, 19104, United States

RECRUITING

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

RECRUITING

Study Officials

• David Recker, M.D.

  Balmoral

  STUDY DIRECTOR

Central Study Contacts

Mary Thacker

CONTACT

574-253-3353; mthacker@capstonedeservices.com, BAL-448-001@capstonedevservices.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2023
• First Posted: November 18, 2023
• Study Start: June 11, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): June 1, 2031
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (9)