The effect of an educational, autonomous and everyday therapeutic approach on the surgical decision and the functional outcome after 3, 12 and 24 months in persons with hallux valgus and a given surgical indication - a randomized, controlled intervention study.

The effect of an educational, autonomous and everyday therapeutic approach on the surgical decision and the functional outcome after 3, 12 and 24 months in persons with hallux valgus and a given surgical indication - a randomized, controlled intervention study. - The F.O.O.T-Study (Functional Operative Orthopaedic Therapy Study)

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00019009

Enrollment

150

Registered

2019-11-20

Start date

2022-07-01

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

M20.1 M77.4

Interventions

Group 1: Treatment group: Spiraldynamik-day-course: physiotherapeutic intervention with a holistic approach (education, self-efficacy, training therapy) Group 2: Control group: Hallux-Valgus silicone

Eligibility

Sex/Gender

All

Age

18 Years to 79 Years

Inclusion criteria

Inclusion criteria: - Signed Informed Consent - Age 20 to 79 years - Hallux valgus foot deformity with/without metatarsalgia eligible for surgical correction of foot deformity - Surgery can wait for at least 12 Weeks - Interested in participating in the study and willing to filling out questionnaires at 4 time points (0, 3, 12, 24 months) - German language capability oral and written - No cognitive dysfunction

Exclusion criteria

Exclusion criteria: - Morton (pseudo) neuroma - Hallux rigidus or advanced arthrosis of the great toe joint (Art. Metatarsophalangealis 1 (MTP1)) in hallux valgus - Dislocated toe joints MTP 2-5; mechanical arthropathy - Rheumatoid arthritis - mid- or rearfoot pain (e.g. Fasciitis, achillodynia) - neuropathic foot pain (e.g. Polyneuropathy, diabetic) - Currently tumor, fracture, trauma to the foot - Condition after forefoot surgery on the affected side - severe gait disability - Known psychiatric condition - Anamnestic confirmation of pregnancy (-> women)

Design outcomes

Primary

Measure	Time frame
The primary outcome of the study is the decision on the operation (OP) (or no surgery) or in other words the frequency of performed surgery in the treatment group compared to the the control group after 24 months.	—

Secondary

Measure	Time frame
Secondary outcomes are the Foot-Function-Index (FFI) as a validated score for pain and function in foot-related complaints, pain and limitation in everyday life, work and leisure, walking, working and sports ability (determined by means of the total scores of the questionnaire "Activity Index »,« EuroQol-5D » and « Karnofsky index ») after 3, 12 and 24 months	—

Countries

Germany, Switzerland

Contacts

Public ContactHeiner Baur

Bern University of Applied Sciences, Health, Physiotherapy

heiner.baur@bfh.ch0041318484515

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Apr 4, 2026