Phase
Condition
N/ATreatment
AeroFit Seal-In Liner / Socket
Seal-In Silicone Liner
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
50Kg< body weight < 136Kg
Cognitive ability to understand all instructions and questionnaires in the study
Intended for unilateral/bilateral individuals that fit the indications for use, fitwithin the specified criteria and with the limb length, shape and ability to use aprosthetic liner: Activity level: K1 - K4, Impact level: Low to high, Amputationlevel: transfemoral
Congenital transverse deficiency at femoral level
Using Seal-In Silicone Liner and Direct Socket or AeroFit Seal-In Liner and AeroFitSocket
Able to use AeroFit Solution, see Figure 7 AeroFit Seal-In Liner Sizes and Figure 8Minimum socket height per liner profile.
Residual limb profile: Standard or conical
Willing and able to participate in the study and follow the protocol
Confident (all day) prosthetic users for more than 3 months
Older than 18 years
Exclusion
Exclusion Criteria:
Participating in another research study that may affect the participation or resultsof this study (in the opinion of the investigator)
Users that have received Botox injection as treatment for residual limb sweat issuein the last 4 months
Study Design
Connect with a study center
Gainesville Prosthetics
Gainesville, Florida 32606
United StatesSite Not Available
NuTech Institute LLC
Indianapolis, Indiana 46202
United StatesSite Not Available
SRT Prosthetics & Orthotics NPC
Indianapolis, Indiana 46202
United StatesSite Not Available
Oakland Orthopedic
Bay City, Michigan 48708
United StatesSite Not Available
Perry Prosthetics
Perrysburg, Ohio 43551
United StatesSite Not Available
Baker Orthotics and Prosthetics
Arlington, Texas 76015
United StatesSite Not Available
Reach Orthotics and Prosthetics Services
Virginia Beach, Virginia 23452
United StatesSite Not Available
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