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Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression (TalarAVN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02291900
Recruitment Status : Unknown
Verified November 2014 by BG Trauma Center Ludwigshafen.
Recruitment status was:  Recruiting
First Posted : November 17, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
BG Trauma Center Ludwigshafen

Brief Summary:
The purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

Condition or disease Intervention/treatment Phase
Avascular Necrosis of Bone Procedure: core decompression Not Applicable

Detailed Description:

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 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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Auto Grafting
Study Start Date : February 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2016

Arm Intervention/treatment
Active Comparator: medial femoral condyle
Patients in this arm receive core decompression followed by free vascularized medial femoral condyle graft
Procedure: core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft

Active Comparator: core decompression
Patients in this arm receive core decompression followed by osseous autograft from the iliac crest
Procedure: core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft




Primary Outcome Measures :
  1. Pain reduction [ Time Frame: 3, 6, 12 months post operation ]

Secondary Outcome Measures :
  1. Lower Extremity Functional Scale [ Time Frame: pre operation; 3, 6, 12 month post operation ]
  2. Revascularization (Association International de Recherche sur la Circulation Osseuse-Criteria) [ Time Frame: 6 and 12 month postoperative ]
  3. American Orthopaedic Foot and Ankle Society- Ankle and Hindfoot Score [ Time Frame: pre operation; 3, 6, 12 month post operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Avascular talar necrosis stage 2 and 3 (Ficat and Arlet)
  • signed patient consent form

Exclusion Criteria:

  • steroid or chemo therapy
  • participation in a different study
  • pregnancy
  • peripheral artery occlusive disease stage 3 and 4
  • avascular talar necrosis stage 1

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02291900


Contacts
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Contact: Victoria F Struckmann, MD 0049-17663158299 vfs@me.com
Contact: Thomas Kremer, PhD, MD 0049-162-68108913 thomas.kremer@bgu-ludwigshafen.de

Locations
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Germany
BG Trauma Center Ludwigshafen Recruiting
Ludwigshafen, Rheinland-Pfalz, Germany, 67071
Contact: Victoria F Struckmann, MD    0049-176-63158299    vfs@me.com   
Contact: Thomas Kremer, PhD, MD    0049-621-68108913    thomas.kremer@bgu-ludwigshafen.de   
Sponsors and Collaborators
BG Trauma Center Ludwigshafen
Investigators
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Study Chair: Ulrich Kneser, Phd, MD BG Trauma Center Ludwigshafen

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Responsible Party: BG Trauma Center Ludwigshafen
ClinicalTrials.gov Identifier: NCT02291900    
Other Study ID Numbers: BGU - 01/14
First Posted: November 17, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by BG Trauma Center Ludwigshafen:
avascular necrosis, talus, medial femoral condyle
Additional relevant MeSH terms:
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Osteonecrosis
Necrosis
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases