Clinical trial NCT06105944: Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation
Official title: Economic Evaluation of Lower Limb Prostheses in the Netherlands Including the Cost-effectiveness of Non-microprocessor Controlled Knees Versus Microprocessor Controlled Knees
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amputation
Prosthesis User
Prosthesis
Keywords: cost-effectiveness
microprocessor knee
economic evaluation
transfemoral amputation
knee-disarticulation
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2023-10-30
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of adults with a unilateral knee-disarticulation or transfemoral amputation who use a prosthesis with an NMPK or MPK.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Costs related to lower limb prosthesis use
timeFrame: At the baseline, participants were asked to fill out the questionnaire over a retrospective period of six months
measure: Health-related quality of life (HRQOL) 1
timeFrame: At the baseline, participants were asked to fill out the questionnaire based on their health status that day.
measure: Health-related quality of life (HRQOL) 2
timeFrame: At the baseline, participants were asked to fill out the questionnaire based on their health status that day.
measure: Prosthesis-related quality of life
timeFrame: At the baseline, participants were asked to fill out the questionnaire over a retrospective period of four weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Livit Orthopedie
city: Assen
country: Netherlands
facility: OIM Orthopedie
Study officials:
References: