AmputationNCT06105944
Economic Evaluation of Lower Limb Prostheses for Persons With a Knee-disarticulation or Transfemoral Amputation
An observational study of Amputation and Prosthesis User, run by University Medical Center Groningen at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Prosthesis User, Prosthesis
- How many people
- 117 participants
- Where
- 2 sitesNetherlands
- Study dates
- 17 Dec 2022to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- At least one year post amputation
- Able to read and write in Dutch
- Use a prosthesis with socket
Who cannot join
- Bilateral amputation
- Osseointegration
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Economic Evaluation of Lower Limb Prostheses in the Netherlands Including the Cost-effectiveness of Non-microprocessor Controlled Knees Versus Microprocessor Controlled Knees
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.
Read more
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.
Read the 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.
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Keywords
- cost-effectiveness, microprocessor knee, economic evaluation, transfemoral amputation, knee-disarticulation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: At the baseline, participants were asked to fill out the questionnaire over a retrospective period of four weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start17 Dec 2022
- Primary completion25 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmputationStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105944
- Sponsor's protocol ID
- 671860-cost
- Status last verified
- Oct 2023
- First submitted
- 23 Aug 2023
- Last updated
- 30 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Evaluation of Lower Limb Prostheses in the Netherlands Including the Cost-effectiveness of Non-microprocessor Controlled Knees Versus Microprocessor Controlled Knees
- ClinicalTrials.gov ID
- NCT06105944
- Acronym / sponsor ID
- 671860-cost
- Conditions
- Amputation, Prosthesis User, Prosthesis
- Keywords
- cost-effectiveness, microprocessor knee, economic evaluation, transfemoral amputation, knee-disarticulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 17 Dec 2022 (actual)
- Primary completion
- 25 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 30 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- At least one year post amputation
- Able to read and write in Dutch
- Use a prosthesis with socket
Key exclusion criteria (2 listed)
- Bilateral amputation
- Osseointegration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Costs related to lower limb prosthesis use
Time frame: 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.
Health-related quality of life (HRQOL) 1
Time frame: 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.
Health-related quality of life (HRQOL) 2
Time frame: 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).
Prosthesis-related quality of life
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation and Prosthesis User, run by University Medical Center Groningen at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs related to lower limb prosthesis use (time frame: At the baseline, participants were asked to fill out the questionnaire over a retrospective period of six months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2023.