Osteochondrosis dissecans : ankle and foot [tarsal, metatarsal, toes, ankle, other joints of the foot].
Conditions
Interventions
Group 1: Patients will be surgically fitted with an ankle spacer. At follow-up (3 months, 6 months, 12 months, and 24 months), the clinical performance of the implant will be measured using clinical s
Sponsors
Orthopädische Klinik der Medizinischen Hochschule im Diakovere Annastift
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Age 18 - 80 years - Indication for implantation of the Ankle Spacer
Exclusion criteria
Exclusion criteria: - Florid infection - Relevant circulatory disorders of the affected leg - Malposition of the OSG > 5° varus or valgus - Fractures of the OSG or ankle joint that occurred less than 6 months ago - Obesity with a BMI > 30 kg/m2 - Known insulin-dependent diabetes mellitus - Known rheumatoid arthritis - Osteoarthritis of the OSG II° or higher according to Kellgren/Lawrence - Deformation of the OSG that does not allow implantation of the Ankle Spacer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim is to collect descriptive data on 10 patients for the following parameters: - Visual Analog Scale (VAS) for pain (1-10) at rest and during exertion/walking. - Ankle-Foot Scale (AOFAS) [18]. - Foot and Ankle Outcome Score (FAOS) [19] - Short-Form-36 Health Survey (SF-36) [20] - Range of motion (measured by goniometer). - Revision rate and implant survival time - Adverse event - Operation time - Length of hospital stay | — |
Secondary
| Measure | Time frame |
|---|---|
| First data collection and descriptive evaluation for a new medical device | — |
Countries
Germany
Contacts
Public ContactYvonne Noll
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift, Leitung Klinisches Studienmanagement
Outcome results
None listed