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

Sponsor
BG Trauma Center Ludwigshafen (Other)
Overall Status
Unknown status
CT.gov ID
NCT02289976
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
33
Duration (Months)
0.6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: core decompression
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated 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 Autografting
Study Start Date :
Feb 1, 2014
Anticipated Primary Completion Date :
Nov 1, 2014
Anticipated Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: femoral condyle

Core decompression of the talar avascular necrosis followed by free microvascular femoral condyle grafting

Procedure: core decompression
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
Active Comparator: core decompression

Core decompression and nonvascularized autograft from the iliac crest

Procedure: core decompression
Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control

Outcome Measures

Primary Outcome Measures

  1. Pain reduction [pre operation; 3, 6, 12 months post operation]

    measured by visual anloge scale

Secondary Outcome Measures

  1. Revascularization of the talus in the MRI [6, 12 month post operation]

    by ARCO-Criteria

  2. Lower Extremity Functional Scale [pre operation; 3, 6, 12 month post operation]

  3. American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score [pre operation; 3, 6, 12 month post operation]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 BG Trauma Center Ludwigshafen Ludwigshafen Rheinland-Pfalz Germany 67071

Sponsors and Collaborators

  • BG Trauma Center Ludwigshafen

Investigators

  • Study Director: Thomas Kremer, Phd, MD, BG Trauma Center Ludwigshafen

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
BG Trauma Center Ludwigshafen
ClinicalTrials.gov Identifier:
NCT02289976
Other Study ID Numbers:
  • BGU-01/14
First Posted:
Nov 13, 2014
Last Update Posted:
Nov 13, 2014
Last Verified:
Nov 1, 2014
Keywords provided by BG Trauma Center Ludwigshafen
talar avascular necrosis
osteochondrosis dissecans
femoral condyle
Additional relevant MeSH terms:
Osteonecrosis
Necrosis

Study Results

No Results Posted as of Nov 13, 2014