We hypothesize that the MMP could be cost-efficient for a part of the patients, but that for some patients a more simple prosthesis would be more cost-efficient. Therefore, we do not expect big differences in cost-effectiveness between the MMP and…
ID
Bron
Verkorte titel
Aandoening
Upper limb defects, including both amputations and congenital deficits.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Cost-utility calculated with the Multi-Attribute Preference Response (MAPR) and total costs from a societal perspective, shown as an incemental cost-effectiveness ratio
Achtergrond van het onderzoek
Last decade costs of health care related to upper limb prosthesis in the Netherlands are raising. The introduction of innovative types of prostheses, like the multi-articulated myoelectric prosthesis (MMP) with moveable thumb and fingers, seems to be one of the causes for this raise. MMPs have functional advantages, but also have disadvantages: less durable, difficult to control, and more expensive. Probably, for some persons, a more simple prosthesis would meet their expectations as well. Current literature about the cost-efficiency of upper limb prosthesis is limited. Therefore the aim of this study was to compare the efficacy, cost-efficiency, and cost-utility of the 'standard' myoelectric upper limb prosthesis (SMP) with the MMP. We will perform a cross-sectional study with a limited cross-over design, which exists of two phases. In the first phase, MMP users are performing several tests with the MMP and SMP to compare the efficacy of these prostheses. In the second phase, persons with an MMP and persons with an SMP are asked to complete surveys about the costs of their prosthesis and all costs related to the prosthesis, quality of life, users' value of the prosthesis, and satisfaction with the prosthesis.
Doel van het onderzoek
We hypothesize that the MMP could be cost-efficient for a part of the patients, but that for some patients a more simple prosthesis would be more cost-efficient. Therefore, we do not expect big differences in cost-effectiveness between the MMP and SMP.
Onderzoeksopzet
Sep 2020: Start inclusion
Okt - Dec 2020: Measurements
Jan - Mar 2021: File investigation
Onderzoeksproduct en/of interventie
NA
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Inclusion criteria phase 1 & 2- MMP group:
- Age 18 years or older
- At least one year experience with an MMP, type be-bionic, I-limb or VINCENT
- Owner of an MMP, type be-bionic, I-limb or VINCENT
- The person is in a stable phase of the prosthesis provision process
- Sufficient command of the Dutch language to follow instructions and complete questionnaires
Inclusion criteria phase 2 - SMP group:
- Age 18 years or older
- At least one year experience with an SMP with one grip mode
- Owner of an SHP with one grip mode
- The person is in a stable phase of the prosthesis provision process
- Sufficient command of the Dutch language to follow instructions and complete questionnaires
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Exclusion criteria phase 1 & 2- MMP group:
- Co-morbidities that could influence the results of this study, like neurological disorders, rheumatic diseases, and other disorders that could affect the arm function
- Owner of an MMP, type Michelangelo
Exclusion criteria phase 2 - SMP group:
- Co-morbidities that could influence the results of this study, like neurological disorders, rheumatic diseases, and other disorders that could affect the arm function
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8730 |
| Ander register | Medical Ethics Review Board of the University Medical Center Groningen (UMCG) : METc2018/582 |