Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression
NCT ID: NCT02289976
Last Updated: 2014-11-13
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 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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femoral condyle
Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting
core decompression
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
core decompression
Core decompression and nonvascularized autograft from the iliac crest
core decompression
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
Interventions
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core decompression
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* surgical revascularization in the past
* participation in a different study
* pregnancy
* peripheral artery occlusive disease
* drug associated talar avascular necrosis
* ongoing steroid therapy or chemo therapy
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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Thomas Kremer, Phd, MD
Role: STUDY_DIRECTOR
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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References
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Ficat RP. Idiopathic bone necrosis of the femoral head. Early diagnosis and treatment. J Bone Joint Surg Br. 1985 Jan;67(1):3-9. doi: 10.1302/0301-620X.67B1.3155745. No abstract available.
BERNDT AL, HARTY M. Transchondral fractures (osteochondritis dissecans) of the talus. J Bone Joint Surg Am. 1959 Sep;41-A:988-1020. No abstract available.
Doi K, Sakai K. Vascularized periosteal bone graft from the supracondylar region of the femur. Microsurgery. 1994;15(5):305-15. doi: 10.1002/micr.1920150505.
Hussl H, Sailer R, Daniaux H, Pechlaner S. Revascularization of a partially necrotic talus with a vascularized bone graft from the iliac crest. Arch Orthop Trauma Surg. 1989;108(1):27-9. doi: 10.1007/BF00934153.
Other Identifiers
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BGU-01/14
Identifier Type: -
Identifier Source: org_study_id