Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression
NCT ID: NCT02291900
Last Updated: 2014-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-02-28
2016-11-30
Brief Summary
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Detailed Description
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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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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medial femoral condyle
Patients in this arm receive core decompression followed by free vascularized medial femoral condyle graft
core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft
core decompression
Patients in this arm receive core decompression followed by osseous autograft from the iliac crest
core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft
Interventions
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core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft
Eligibility Criteria
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Inclusion Criteria
* signed patient consent form
Exclusion Criteria
* participation in a different study
* pregnancy
* peripheral artery occlusive disease stage 3 and 4
* avascular talar necrosis stage 1
18 Years
ALL
No
Sponsors
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BG Trauma Center Ludwigshafen
OTHER
Responsible Party
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Principal Investigators
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Ulrich Kneser, Phd, MD
Role: STUDY_CHAIR
BG Trauma Center Ludwigshafen
Locations
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BG Trauma Center Ludwigshafen
Ludwigshafen am Rhein, Rhineland-Palatinate, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BGU - 01/14
Identifier Type: -
Identifier Source: org_study_id