Avascular Necrosis of Bone Clinical Trial
Official title:
Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Autografting
The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.
The aim of this prospective randomized clinical trial is the comparison of two surgical
treatment options for talar avascular necrosis (analogical to Ficat and Arlet stage II and
III). The randomized study design allows direct comparability of the outcome after either
core decompression and nonvascularized osseous autografting from the iliac crest or core
decompression and osseous autografting with a free microvascular medial femoral condyle.
Talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and
destruction of the talar bone. The extend of this malperfusion is variable and can be
categorized in 4 stages. The osseous defects can remain without consequences (stage I) or
lead to irreversible talar destruction. The current treatment option for stage II and III is
the core decompression followed by osseous auto grafting from the iliac crest. Reducing the
intraosseal pressure and filling the drill holes with the nonvascularized bone graft can
lead to reperfusion of the talus.
A new technique is to fill the drill hole with a vascularized bone graft from the medial
femoral condyle, using microvascular anastomosis. This procedure has already been approved
for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid)
as well as the femoral head.
Patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting
the active range of motion and pain sensation while resting and on activity. Well
established scores like the AOFAS Ankle-Hindfoot Score and the Lower Extremity Functional
Scale are used to get subjective and objective informations about patients' daily life and
postoperative satisfaction. X-Rays are taken at the same stages. MRIs of the ankle joint
with contrast agent are performed before as well as 6 and 12 months after surgery.
Statistical analysis is performed using the Statistical Package for the Social Sciences
(SPSS). The Study protocol has been approved by the Ethics Commission of Rheinland-Pfalz.
Interventions are done according to the declaration of Helsinki.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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