Status:
COMPLETED
Prospective 2-year Data Collection of the First 10 Patients After Ankle Spacer Implantation
Lead Sponsor:
Hannover Medical School
Conditions:
Osteochondritis Dissecans
Eligibility:
All Genders
18-80 years
Brief Summary
Osteochondral defects (OCD) of the talus are pathologic lesions of the talar cartilage and its subchondral bone and might severely deteriorate the quality of life. For the treatment of multiple and/or...
Detailed Description
One surgeon in the investigator's center implanted 10 Ankle Spacers between April 2018 and October 2020. The average age was 41.7 years (20 - 70 years). All patients get a standard followed-up at 6 we...
Eligibility Criteria
Inclusion
- Women and men aged 18-80 years
- Indication for implantation of the ankle spacer
Exclusion
- Florid infections
- Relevant circulatory disorders on the affected leg
- Malposition of the OSG (upper ankle Joint) greater than 5 ° varus or valgus
- Fractures of the OSG or near the ankle that were less than 6 months ago
- Obesity with a BMI greater than 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, which does not allow implantation of the ankle spacer
Key Trial Info
Start Date :
January 18 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 3 2021
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04297449
Start Date
January 18 2019
End Date
September 3 2021
Last Update
September 16 2021
Active Locations (1)
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1
Orthopädische Klinik der Medizinischen Hochschule Hannover im DIAKOVERE Annastift
Hanover, Lower Saxony, Germany, 30625