Lower limb bone-anchored prosthetic users
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18 years or older.Able to provide informed consent.Underwent a uni-lateral transtibial BAP surgery more than 2 years ago.Able to walk independently and able to perform high-impact activities, as defined by Medicare Functional Classification Level (MFC-level) [5] categorization score K4.
Exclusion criteria
Exclusion criteria: Having any cognitive, communicative, or visual limitations as well as physical co-morbidity, that would hinder or not be safe to execute mid-to-high demand activities during the measurements. Current problems with the BAP which limits the potential participant from executing the research protocol. BAP-users with a nexus connector, as these connectors are not allowed within MRI and CT scanning devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameters are the spatial distribution and peak von Mises stress/strength ratio (safety) of the tibial bone, computed from Quantitative CT and measured forces (N) and moments (Nm) on the implant during different activities. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary study parameters are the patient characteristics, including age, sex, height, weight, medication, weight of the prosthesis, residual limb and sound limb characteristics, cause of amputation, side of amputation, time since amputation, time since surgery for the bone anchored implant, and components of the prosthesis. | — |
Countries
Netherlands
Contacts
Public ContactGM Kooiman
Radboud Universitair Medisch Centrum
Outcome results
None listed