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

Sponsor
University Medical Center Groningen (Other)
Overall Status
Completed
CT.gov ID
NCT06105944
Collaborator
ZonMw: The Netherlands Organisation for Health Research and Development (Other)
117
2
5.4
58.5
10.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    117 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Economic Evaluation of Lower Limb Prostheses in the Netherlands Including the Cost-effectiveness of Non-microprocessor Controlled Knees Versus Microprocessor Controlled Knees
    Actual Study Start Date :
    Dec 17, 2022
    Actual Primary Completion Date :
    May 25, 2023
    Actual Study Completion Date :
    May 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Costs related to lower limb prosthesis use [At the baseline, participants were asked to fill out the questionnaire over a retrospective period of six months]

      To get insight in the costs, two existing questionnaires were combined: the Productivity Cost Questionnaire (iPCQ) and the Medical Consumption Questionnaire (iMCQ). The iMCQ is used to measure medical consumption. It includes questions related to the number of appointments with health care providers. The iPCQ measures and values productivity losses. It looks at absenteeism, presenteeism, productivity losses and unpaid work. As this study focussed on costs related to lower limb prostheses, questions about appointments with a dietician and speech therapist, and trips to the emergency room were replaced with questions about the type of prosthesis and the number of appointments with their prosthetist. Finally, questions about personal costs related to the acquisition and repairs of the prosthesis, as well as personal expenses were added. As this questionnaire looks at number of appointments and costs, there is no minimum or maximum value score.

    2. Health-related quality of life (HRQOL) 1 [At the baseline, participants were asked to fill out the questionnaire based on their health status that day.]

      To evaluate the HRQOL, participants were asked to fill out the Dutch version of the EuroQol - five dimensions - five levels (EQ-5D-5L). This is a self-assessment tool that consists of five questions about mobility, self-care, daily activities, pain and anxiety/depression. For each question, the participant can answer with five response levels: no problems, slight problems, moderate problems, severe problems, extreme problems/unable to do so. The Dutch scoring algorithm for the EQ-5D-5L was used to compute a solitary value representing the health status of the participant. The calculated values fall within the range of -0.446 to 1, where higher scores denote enhanced HRQOL.

    3. Health-related quality of life (HRQOL) 2 [At the baseline, participants were asked to fill out the questionnaire based on their health status that day.]

      At the end of the EQ-5D-5L, participants were asked to rate their perceived health that day on a visual analogue scale (VAS) of 0 (worst health imaginable) to 100 (best health imaginable).

    4. Prosthesis-related quality of life [At the baseline, participants were asked to fill out the questionnaire over a retrospective period of four weeks.]

      To measure the prosthesis related quality of life, participants filled out parts of the Prosthesis Evaluation Questionnaire (PEQ). The PEQ is a self-report questionnaire to evaluate prosthesis and prosthesis-related quality of life. Questions focus on use, satisfaction, quality of life, tripping and falling. The subscales used in the PEQ are not dependent on each other and can therefore be used independently to fit the research question. For this study, three subscales were utilized: utility, ambulation and well-being. The questions are scored on a visual analogue scale (VAS) from 0-100. A higher score on this questionnaire is linked to a more positive outcome.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Livit Orthopedie Amsterdam Netherlands
    2 OIM Orthopedie Assen Netherlands

    Sponsors and Collaborators

    • University Medical Center Groningen
    • ZonMw: The Netherlands Organisation for Health Research and Development

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Medical Center Groningen
    ClinicalTrials.gov Identifier:
    NCT06105944
    Other Study ID Numbers:
    • 671860-cost
    First Posted:
    Oct 30, 2023
    Last Update Posted:
    Oct 30, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Medical Center Groningen

    Study Results

    No Results Posted as of Oct 30, 2023