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BASSP study

Clinical- and cost-effectiveness of bone-anchored and socket-suspended leg protheses - BASSP-study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58575
Enrollment
104
Registered
2026-04-24
Start date
2026-05-29
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Socket-related problems Socket-related problems

Interventions

Patients receiving osseointegration implant surgery based on shared decision-making in usual care will constitute the BAP cohort. This intervention includes surgery for the purpose of the attachment o

Sponsors

Radboud Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with socket-related problems contributing to limited prosthetic use or prosthestic comfort. 

Exclusion criteria

Exclusion criteria: Complaints are not related to the prosthetic socket

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be disease specific health-related quality of life.

Secondary

MeasureTime frame
The secondary outcomes include: Quality adjusted life years (QALYs) costs, generic health related quality of life, prosthetic wearing time, back pain, mobility level, walking ability, work participation, prosthesis comfort, intervention-related adverse events and Continuous Daily activity monitoring Outcome Measures (CoDaOMs) using an activity tracker. 

Countries

Netherlands

Contacts

Public ContactRuud Leijendekkers

Radboud Universitair Medisch Centrum

ruud.leijendekkers@radboudumc.nl(024) 3655286

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026