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Clinical Trials/DRKS00019009
DRKS00019009
Recruiting
未知

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)

Spiraldynamik Holding AG0 sites150 target enrollmentNovember 20, 2019

Overview

Phase
未知
Intervention
Not specified
Conditions
M20.1
Sponsor
Spiraldynamik Holding AG
Enrollment
150
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2019
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
Spiraldynamik Holding AG

Eligibility 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

  • \- 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

Outcomes

Primary Outcomes

Not specified

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