Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04297449 |
Other study ID # |
8198_MPG_23b_2018 |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
January 18, 2019 |
Est. completion date |
September 3, 2021 |
Study information
Verified date |
September 2021 |
Source |
Hannover Medical School |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial 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 large talar OCDs and in patients with failed previous surgical treatment the
Ankle Spacer was developed. Six patients are included in a prospective clinical and
radiological study with a follow-up of two years.
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 weeks, 12 weeks. After the first four patients, all following patients are
enrolled in a prospective study and where followed up after 1 and 2 years additionally. The
American Orthopaedic Foot and Ankle Society (AOFAS) Score, the Foot and Ankle Outcome Score
(FAOS), the European Foot and Ankle Score (EFAS), the Visual Analogue Scale (VAS) for pain
are collected. Radiographic parameters such as implant loosening, cystic changes,
lateral/medial prominence of the implant, congruency to the talar rounding, progression of
osteoarthritis or bone ware of the tibia plafond are recorded. The Ankle Spacer is a
one-piece implant system that replaces the articulating upper talus surface of the
tibio-talar joint, and offers several implant sizes in order to fit to the different talus
sizes. It is anatomically designed to the native upper talus surface to provide an optimal
fit to the distal articular surface. It has a rough titanium plasma spray (TPS) coated under
surface with two posts and spikes for implant fixation. The rough surface enables secondary
fixation by means of bone ingrowth and the spikes at the posterior part of the prosthesis
allowing for optimal adherence of the implant and for minimal iatrogenic damage upon
fixation. By these means, the anatomical situation and the natural congruency of the ankle
joint are mirrored to an optimal extent.