Skip to content

Clinical usability of non-contact scanners in measuring stumpvolume of transtibial amputee patients

Clinical usability of non-contact scanners in measuring stumpvolume of transtibial amputee patients - CCUNCMSTAP

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON45575
Enrollment
36
Registered
2017-03-13
Start date
2017-04-28
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amputatie transtibial amputation

Interventions

amputee
CAD/CAM systems
stump volume
trans-tibial

Sponsors

Isala Klinieken
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Uni- or bilateral transtibial amputation Operation of the stump more than 1 year ago Older than 18 years Informed consent Availability at research data

Exclusion criteria

Exclusion criteria: Less than 1 year ago an operation of the stump Large changes in stump volume during the day with co-morbidity like heart failure, kidney failure, deep vein thrombosis, lymphedema, fracture of the leg, rheumatoid artritis, CRPS, dermatologic diseases associated with edema. Wound at the stump of more than 1 cm amplitude and/or signs of infection, in which clinically may be assumed that this will influence the stumpvolume Weakness of upperleg which causes inability to lift the leg up in the air Not able to make a transfer from (wheel)chair to research table Not enough understanding of the Dutch language to give answer to simple questions, follow simple instructions or understand the informed consent letter

Design outcomes

Primary

MeasureTime frame
Stumpvolume will be calculated per patient per CAD/CAM system, where the mid-patellar tendon point, tibial crest and supracondylar level will be used as measurement points. So every session there will be 8 measurements per patient, which will be repeated the second session. Per system per patient there will be a mean measured volume calculated per researcher and per session. With that the repeatability coefficient for intra-observer and test-retest reliability will be calculated.

Secondary

MeasureTime frame
The PSSUQ will be collected per CAD/CAM system in every researcher. Patients will be asked about how they experience the measurement on a scale from 1 to 10. The mean score per system will be calculated and compared. Also the mean time necessary to perform the measurement will be calculated per CAD/CAM system. The shorter the mean time necessary per measurement, the better.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)