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.

Not Applicable

• Conditions: M20.1; M77.4; Hallux valgus (acquired); Metatarsalgia

• Registration Number: DRKS00019009
• Lead Sponsor: Spiraldynamik Holding AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting withdrawn before recruiting started
• Sex: All
• Target Recruitment: 150

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

- 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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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