The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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.
UC Davis Medical Center
Sacramento, California, United States
RECRUITINGUniversity of Colorado Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGThe 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.
Time frame: Two (2) years post-implantation
Overall infection rate
Overall infection rate subclassified as deep or superficial to the fascia.
Time frame: Two (2) and Five (5) years post-implantation
Lack of secondary surgical intervention
Lack of secondary surgical intervention
Time frame: Two (2) and Five (5) years post-implantation
Orthotics and Prosthetics Users Survey: Satisfaction with Devices
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).
Time frame: Two and Five (2-5) years post-implantation
Prosthetic Wear Time
Prosthetic Wear Time- Hours per Day.
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Physical Function
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).
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Walter Reed Military Medical Center
Washington D.C., District of Columbia, United States
RECRUITINGNorthwestern Memorial Hospital
Chicago, Illinois, United States
RECRUITINGThe Johns Hopkins Hospital
Baltimore, Maryland, United States
RECRUITINGMemorial Sloan Kettering Cancer Center
New York, New York, United States
RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGPenn Medicine; University of Pennsylvania Health System
Philidelphia, Pennsylvania, United States
RECRUITINGUniversity of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
RECRUITINGTime frame: Two (2) and Five (5) years post-implantation
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.
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 Devices
Time frame: Two (2) and Five (5) 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 with no more than 2 superficial infections per year and no more than 3 superficial infections in the first two years post-implantation.
Time frame: Two (2) years post-implantation
The proportion of participants who have had serious device-related adverse events.
The proportion of participants who have had serious device-related adverse events.
Time frame: Two (2) and Five (5) years post-implantation
Type and frequency of mechanical complications over time.
Any mechanical complications will be recorded and evaluated for device deficiencies.
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Intensity
Pain Intensity domain measures self-reported pain on a scale of 0 (No Pain) to 10 (Worst imaginable pain).
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Behavior
Measures self-reported external manifestations of pain: behaviors that typically indicate to others that an individual is experiencing pain.
Time frame: Two (2) and Five (5) years post-implantation
Patient Reported Outcome Measurement Information System: Pain Interference
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
Time frame: Two (2) and Five (5) years post-implantation