Skip to content

Cost-effectiveness of footwear modification for first metatarsophalangeal joint osteoarthritis

Cost-effectiveness of footwear modification for first metatarsophalangeal joint osteoarthritis - MTP-1 OA Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57221
Enrollment
136
Registered
2024-11-11
Start date
2025-06-17
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

MTP-1 joint osteoarthritis

Interventions

Patients randomized to the intervention group will, in addition to usual GP&nbsp
care, be referred to an orthopedic shoemaker. The intervention is defined as OVAC, which stands for footwear modification of ready-made footwear (confection shoes), including the following options, de

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - aged 45 years or older - able to walk with or without assistance devices  - proficient in Dutch language   - confirmed diagnosis of MTP-1 joint OA by a health care professional.  - pain in the foot needs to be present on most days of last month and  - presence of morning stiffness or stiffness during the day int he MTP-1 joint

Exclusion criteria

Exclusion criteria: - Patients that have already received footwear modifications (OVAC) or custom-made orthopedic shoes in the past. - Patients that have undergone surgery as treatment for MTP-1 osteoarthritis in the affected foot.  - Patients that are contraindicative to receive an OVAC, because they use a splint or brace, or because their feet will not fit in an OVAC because of other foot problems.  

Design outcomes

Primary

MeasureTime frame
Walking pain (11-point NRS) at 6 months follow-up Quality-Adjusted Life-Years (EQ-5D) at 6 months follow-up Societal costs over 6 months, using iMCQ and iPCQ questionnaires

Secondary

MeasureTime frame
Self-reported recovery (GROC), foot function (FHSQ) and PASS at 6 and 12 months follow-up* Barriers and facilitators of patients and health care professionals for the implementation of the intervention in general practice

Countries

Netherlands

Contacts

Public ContactM Middelkoop

Erasmus MC, Universitair Medisch Centrum Rotterdam

kwaliteithag@erasmusmc.nl0107030004

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Mar 20, 2026