Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation

NCT ID: NCT06105944

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

117 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-17

Study Completion Date

2023-05-31

Brief Summary

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The goal of this retrospective questionnaire study is to evaluate the cost-effectiveness of non-microprocessor controlled prosthetic knees (NMPK) versus microprocessor controlled prosthetic knees (MPK) in persons with a knee-disarticulation or transfemoral amputation. The main aims are:

* to provide an overview of the costs, health-related quality of life, and user experiences associated with the use of different types of prosthetic knees.
* to evaluate the cost-effectiveness of the NMPK compared to the MPK for adult prosthesis users.

Participants will fill out three questionnaires about (1) their medical consumption and productivity costs; (2) health-related quality of life; (3) utility, ambulation and well-being.

Researchers will compare the persons with a NMPK to the persons with an MPK to investigate the cost-efficiency of both types of knees.

Detailed Description

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A transfemoral amputation or knee disarticulation can have a negative influence on a person's daily activities, participation, and other aspects of daily life. In previous studies it has been suggested that the use of a microprocessor-controlled knee (MPK) can help increase functional mobility, decrease falls and stumbles and improve quality of life. Although there is a hefty cost associated with this type of knee, it is not certain this outweighs the potential gains.

Conditions

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Amputation Prosthesis User Prosthesis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* At least one year post amputation
* Able to read and write in Dutch
* Use a prosthesis with socket

Exclusion Criteria

* Bilateral amputation
* Osseointegration
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Livit Orthopedie

Amsterdam, , Netherlands

Site Status

OIM Orthopedie

Assen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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671860-cost

Identifier Type: -

Identifier Source: org_study_id

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