Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression (TalarAVN)
Primary Purpose
Avascular Necrosis of Bone
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
core decompression
Sponsored by
About this trial
This is an interventional treatment trial for Avascular Necrosis of Bone focused on measuring talar avascular necrosis, osteochondrosis dissecans, femoral condyle
Eligibility Criteria
Inclusion Criteria:
- patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)
Exclusion Criteria:
- talar avascular necrosis stage I (without need for surgical intervention)
- 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
Sites / Locations
- BG Trauma Center LudwigshafenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
femoral condyle
core decompression
Arm Description
Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting
Core decompression and nonvascularized autograft from the iliac crest
Outcomes
Primary Outcome Measures
Pain reduction
measured by visual anloge scale
Secondary Outcome Measures
Revascularization of the talus in the MRI
by ARCO-Criteria
Lower Extremity Functional Scale
American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score
Full Information
NCT ID
NCT02289976
First Posted
November 10, 2014
Last Updated
November 12, 2014
Sponsor
BG Trauma Center Ludwigshafen
1. Study Identification
Unique Protocol Identification Number
NCT02289976
Brief Title
Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression
Acronym
TalarAVN
Official Title
Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Autografting
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
November 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BG Trauma Center Ludwigshafen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 medial femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Avascular Necrosis of Bone
Keywords
talar avascular necrosis, osteochondrosis dissecans, femoral condyle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
femoral condyle
Arm Type
Active Comparator
Arm Description
Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting
Arm Title
core decompression
Arm Type
Active Comparator
Arm Description
Core decompression and nonvascularized autograft from the iliac crest
Intervention Type
Procedure
Intervention Name(s)
core decompression
Intervention Description
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
Primary Outcome Measure Information:
Title
Pain reduction
Description
measured by visual anloge scale
Time Frame
pre operation; 3, 6, 12 months post operation
Secondary Outcome Measure Information:
Title
Revascularization of the talus in the MRI
Description
by ARCO-Criteria
Time Frame
6, 12 month post operation
Title
Lower Extremity Functional Scale
Time Frame
pre operation; 3, 6, 12 month post operation
Title
American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score
Time Frame
pre operation; 3, 6, 12 month post operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with talar avascular necrosis without response to non-surgical treatment (immobilization) and with need for surgical intervention (Ficat and Arlet stage II and III; Berndt and Harty stage II and III)
Exclusion Criteria:
talar avascular necrosis stage I (without need for surgical intervention)
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Victoria F Struckmann, MD
Phone
0049-17663158299
Email
vfs@me.com
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Kremer, Phd, MD
Phone
0049-162-68108913
Email
thomas.kremer@bgu-ludwigshafen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Kremer, Phd, MD
Organizational Affiliation
BG Trauma Center Ludwigshafen
Official's Role
Study Director
Facility Information:
Facility Name
BG Trauma Center Ludwigshafen
City
Ludwigshafen
State/Province
Rheinland-Pfalz
ZIP/Postal Code
67071
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victoria F Struckmann, MD
Phone
0049-176-63158299
Email
vfs@me.com
First Name & Middle Initial & Last Name & Degree
Thomas Kremer, PhD, MD
Phone
0049-621-68108913
Email
thomas.kremer@bgu-ludwigshafen.de
12. IPD Sharing Statement
Citations:
PubMed Identifier
3155745
Citation
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.
Results Reference
background
PubMed Identifier
13849029
Citation
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.
Results Reference
background
PubMed Identifier
7934797
Citation
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.
Results Reference
result
PubMed Identifier
2643938
Citation
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.
Results Reference
result
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Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression
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