RecruitingNCT06031922

Effectiveness and Cost-effectiveness of Lower Limb Prostheses

Comparing the Effectiveness and Cost-effectiveness of Conventional Mechanical Knees and Microprocessor-controlled Knees: a Prospective Cohort Study


Sponsor

University Medical Center Groningen

Enrollment

28 participants

Start Date

Jun 1, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to investigate the effectiveness of NMPKs versus MPKs in persons with an LLA in the standard healthcare system in the Netherlands taking all levels of the ICF model into account. Our main aim is to assess the effect of MPK use compared to NMPK use on walking distance, as this is one of the most used outcome variables in literature and thus enables comparison with previous studies. Our secondary aim is to investigate the effect of NMPKs versus MPKs on all ICF-levels: body structures and function, activities and participation. Participants will be seen four times in a year. During these measurement moments they will: * Perform two physical tests * Fill out a set of questionnaires * Wear an activity tracker for one week


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • At least one year post amputation
  • Unilateral transfemoral amputation or knee-disarticulation
  • Eligible for a trial on an MPK
  • Able to read and write in Dutch
  • Use a prosthesis with a socket

Exclusion Criteria3

  • Bilateral amputation
  • Osseointegration
  • Previous experience with an MPK

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Interventions

DEVICEMicroprocessor controlled knee

Microprocessor controlled knee


Locations(9)

Revant medisch specialistische revalidatie

Breda, Netherlands

Revalidatiecentrum Roessingh

Enschede, Netherlands

Revant medisch specialistische revalidatie | Lindenhof

Goes, Netherlands

University Medical Center Groningen

Groningen, Netherlands

Adelante zorggroep

Hoensbroek, Netherlands

Rijndam Revalidatie

Rotterdam, Netherlands

De Hoogstraat Revalidatie

Utrecht, Netherlands

Heliomare Centrum voor Specialistische Revalidatie

Wijk aan Zee, Netherlands

Vogellanden, centrum voor medisch specialistische revalidatie, bijzondere tandheelkunde en gezonde leefstijl

Zwolle, Netherlands

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NCT06031922


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