Z89
Conditions
Interventions
Group 1: Clinical Registry/observational.
Patient questionnaire, CPO questionnaire and functional tests: before the routine prosthetic fitting, after the routine prosthetic fitting, and during follow
Sponsors
Ottobock SE & Co. KGaA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Subject is unilateral or bilateral lower limb amputee. • Subject will be fitted with a new prosthesis, or at least one major component of their original prosthesis is being replaced. • Subject will be fitted by a CPO from the prosthetic clinics partici-pating in the study. • Subject is willing and able to independently provide informed consent. In case of underage subjects, the informed consent should be provided in accordance with the local regulations either by subject or their legal representative. • Subject is willing and able to answer the questionnaires.
Exclusion criteria
Exclusion criteria: • Subject is unwilling/unable to follow instructions. • Subject cannot provide inform consent. • Subject is unwilling/unable to answer the questionnaires. • The expected mobility level of the subject after the fitting is K0 ac-cording to the Medicare Functional Classification Level (MFCL)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To characterize the improvement in walking distance with a new prosthe-sis, prosthesis component or socket measured by the Six-Minute Walk Test (6MWT) To characterize the improvement in mobility, balance and risk of falling with a new prosthesis, prosthesis component or socket measured by Timed Up and Go (TUG) Test or Four Square Step Test (FSST) depending on the expected mobility grade To characterize the improvement in health-related quality of life with a new prosthesis, prosthesis component or socket assessed by the EQ-5D-5L To characterize the improvement in mobility or confidence in daily activi-ties with a new prosthesis, prosthesis component or socket measured assessed by the Activities-specific Balance Confidence (ABC) score or Locomotor Capabilities Index in Amputees (LCI) score and the Prosthetic Limb Users Survey of Mobility (PLUS-M) score To detect the number of falls within the last six months | — |
Secondary
| Measure | Time frame |
|---|---|
| To characterize the reduction of limb, back and phantom pain with a new prosthesis, prosthesis component or socket assessed by visual analogue scales (VAS) To characterize the improvement of the prosthesis and socket satisfac-tion with a new prosthesis, prosthesis component or socket | — |
Countries
Germany, India
Contacts
Public ContactPawel Maciejasz
Ottobock SE & Co KGaA
Outcome results
None listed