A Study to Evaluate the Safety and Effectiveness Transdermal Compress Device in Participants with Transfemoral Amputations
- Conditions
- Prosthesis and Implants
- Interventions
- Device: Transdermal Compress Device
- Registration Number
- NCT06134167
- Lead Sponsor
- Balmoral Medical company
- Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
- Detailed Description
This study is a prospective, multicenter, single-arm, open-label study in skeletally mature participants with transfemoral limb loss (unilateral or bilateral), without bone or vascular disease who have or are anticipated to have rehabilitation problems with or cannot use a conventional socket prosthesis.
Study participants will undergo surgical implantation of the Transdermal Compress device on Study Day 1.
Participant progression including clinical assessments and prosthetic use will follow the study rehabilitation protocol.
Events of special interest include superficial and deep infections at the implant site, failures, and secondary surgical interventions; participants will be followed for all soft tissue interface issues.
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.
Adverse events and adverse device effects will be collected and reported starting at the time of surgical implantation.
Study participants will also be included in the Osseointegration Quality Registry in parallel to this study to allow for long-term follow-up post-study.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transdermal Compress Device Transdermal Compress Device 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Patient Reported Outcome Measurement Information System: Pain Intensity Two (2) and Five (5) years post-implantation Pain Intensity domain measures self-reported pain on a scale of 0 (No Pain) to 10 (Worst imaginable pain).
Patient Reported Outcome Measurement Information System: Pain Interference Two (2) and Five (5) years post-implantation They include observable displays (sighing, crying), pain severity behaviors (resting, guarding, facial expressions, and asking for help), and verbal reports of pain. The scale contains 7-question rating to evaluate pain behavior on a 6 point scale (1 = Had no pain, 6 = Always have pain
Orthotics and Prosthetics Users Survey: Satisfaction with Devices Two and Five (2-5) years post-implantation 21-item scale that measures satisfaction with the prosthetic device and care quality. Items are rated on 5 points (1 = Strongly agree to 5 = Strongly Disagree).
A composite endpoint will be evaluated to determine the proportion of participants who are successes on both the primary effectiveness and safety endpoints at 2 years and 5 years. Two (2) and Five (5) years post-implantation The following endpoint components will be used to assess effectiveness in the composite endpoint:
Prosthetic Wear Time Patient Reported Outcome Measurement Information System: Physical Function Orthotics and Prosthetics Users Survey: Satisfaction with DevicesType and frequency of mechanical complications over time. Two (2) and Five (5) years post-implantation Any mechanical complications will be recorded and evaluated for device deficiencies.
Patient Reported Outcome Measurement Information System: Pain Behavior Two (2) and Five (5) years post-implantation Measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.
Lack of secondary surgical intervention Two (2) and Five (5) years post-implantation Lack of secondary surgical intervention
Prosthetic Wear Time Two (2) and Five (5) years post-implantation Prosthetic Wear Time- Hours per Day.
Patient Reported Outcome Measurement Information System: Physical Function Two (2) and Five (5) years post-implantation Clinical outcome assessment (COA) that measures the patient's experience with the use of a transdermal device in that the primary goal is to improve physical function.: Physical Function. Items on are rated on 5 points (1 = unable to do. 5 = Without any difficulty).
Overall infection rate Two (2) and Five (5) years post-implantation Overall infection rate subclassified as deep or superficial to the fascia.
The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation. Two (2) years post-implantation The proportion of participants with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
The proportion of participants who have had serious device-related adverse events. Two (2) and Five (5) years post-implantation The proportion of participants who have had serious device-related adverse events.
Trial Locations
- Locations (9)
UC Davis Medical Center
🇺🇸Sacramento, California, United States
University of Colorado Anschutz Medical Campus
🇺🇸Aurora, Colorado, United States
Walter Reed Military Medical Center
🇺🇸Washington, District of Columbia, United States
Northwestern Memorial Hospital
🇺🇸Chicago, Illinois, United States
The Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
The Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
Penn Medicine; University of Pennsylvania Health System
🇺🇸Philidelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburg, Pennsylvania, United States