Transdermal Compress IDE Study
ConditionProsthesis and Implants
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBalmoral Medical company
About this trial
The purpose of this study is to evaluate the safety and effectiveness of the Transdermal Compress device in participants with Transfemoral Amputations.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Transdermal Compress Device
DeviceStudy 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Transdermal Compress DeviceExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Two (2) years post-implantationSecondary outcomes
1
Overall infection rate
Overall infection rate subclassified as deep or superficial to the fascia.
Time frame
Two (2) and Five (5) years post-implantation2
Lack of secondary surgical intervention
Lack of secondary surgical intervention
Time frame
Two (2) and Five (5) years post-implantation3
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-implantation4
Prosthetic Wear Time
Prosthetic Wear Time- Hours per Day.
Time frame
Two (2) and Five (5) years post-implantationOther outcomes
1
Radiographic Outcomes
Review images to determine: Spindle-Anchor Plug Gap measures \> 0.0mm No Spindle-Anchor Plug gap loss No progressive radiolucencies No progressive cortical thinning No femoral shaft fracture No osteolysis at the bone-spindle interface No migration/subsidence No aseptic loosening. Implant integrity is intact.
Time frame
Two (2) and Five (5) years post-implantationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov