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

Talar Avascular Necrosis: Surgical Angiogenesis Compared to Core Decompression With Osseous Auto Grafting

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.

Study Overview

• Status: Unknown
• Conditions: Avascular Necrosis of Bone
• Intervention / Treatment: Procedure: core decompression

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria F Struckmann, MD; Phone Number: 0049-17663158299; Email: vfs@me.com
• Study Contact Backup: Name: Thomas Kremer, PhD, MD; Phone Number: 0049-162-68108913; Email: thomas.kremer@bgu-ludwigshafen.de

Study Locations

• Germany
  • Rheinland-Pfalz
    • Ludwigshafen, Rheinland-Pfalz, Germany, 67071
      • Recruiting
      • BG Trauma Center Ludwigshafen
      • Contact: Victoria F Struckmann, MD; Phone Number: 0049-176-63158299; Email: vfs@me.com
      • Contact: Thomas Kremer, PhD, MD; Phone Number: 0049-621-68108913; Email: thomas.kremer@bgu-ludwigshafen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pain reduction	3, 6, 12 months post operation

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: BG Trauma Center Ludwigshafen
• Investigators: Study Chair: Ulrich Kneser, Phd, MD, BG Trauma Center Ludwigshafen

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): November 1, 2015
• Study Completion (Anticipated): November 1, 2016

Study Registration Dates

• First Submitted: November 12, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 17, 2014

Study Record Updates

• Last Update Posted (Estimate): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 15, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: avascular necrosis, talus, medial femoral condyle
• Additional Relevant MeSH Terms: Pathologic Processes; Musculoskeletal Diseases; Bone Diseases; Necrosis; Osteonecrosis
• Other Study ID Numbers: BGU - 01/14