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

NCT06105944 | Completed

• 1 other identifier: 671860-cost
• Study Type: observational
• Target: 117
• Locations: 1 country
• Sites: 2

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.

Conditions

Amputation; Prosthesis User; Prosthesis

Keywords

cost-effectiveness; microprocessor knee; economic evaluation; transfemoral amputation; knee-disarticulation

Outcome Measures

Primary Outcomes (4)

• Costs related to lower limb prosthesis use

  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.

  At the baseline, participants were asked to fill out the questionnaire over a retrospective period of six months

• Health-related quality of life (HRQOL) 1

  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.

  At the baseline, participants were asked to fill out the questionnaire based on their health status that day.

• Health-related quality of life (HRQOL) 2

  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).

  At the baseline, participants were asked to fill out the questionnaire based on their health status that day.

• Prosthesis-related quality of life

  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.

  At the baseline, participants were asked to fill out the questionnaire over a retrospective period of four weeks.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Bilateral amputation
• Osseointegration

Sponsors & Collaborators

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

Study Sites (2)

Livit Orthopedie

Amsterdam, Netherlands

Location

OIM Orthopedie

Assen, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: October 30, 2023
• Study Start: December 17, 2022
• Primary Completion: May 25, 2023
• Study Completion: May 31, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Locations

NL (2)