DRKS00019061Enrolling By InvitationNot Applicable
Ottobock Outcome Registry - International post-marketing prospective observational evaluation of routine prosthetic patient care of lower limb amputees - Ottobock Outcome Registry
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Ottobock SE & Co. KGaA
- Enrollment
- 5,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- one to one (—)
- Sex
- All
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
- •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)
Investigators
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