Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression

Avascular Necrosis of Bone Clinical Trial

— TalarAVN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02291900
• Other study ID #: BGU - 01/14
• Status: Recruiting
• Phase: N/A
• First received: November 12, 2014
• Last updated: November 15, 2014
• Start date: February 2014
• Est. completion date: November 2016

Study information

• Verified date: November 2014
• Source: BG Trauma Center Ludwigshafen
• Contact: Victoria F Struckmann, MD
• Phone: 0049-17663158299
• Email: vfs[@]me.com
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Avascular Necrosis of Bone
• Necrosis
• Osteonecrosis

Intervention

Procedure:
• core decompression
retrograd drilling of the avascular talar necrosis, followed by osseous autograft

Locations

Country	Name	City	State
Germany	BG Trauma Center Ludwigshafen	Ludwigshafen	Rheinland-Pfalz

Sponsors (1)

Lead Sponsor	Collaborator
BG Trauma Center Ludwigshafen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain reduction		3, 6, 12 months post operation	No
Secondary	Lower Extremity Functional Scale		pre operation; 3, 6, 12 month post operation	No
Secondary	Revascularization (Association International de Recherche sur la Circulation Osseuse-Criteria)		6 and 12 month postoperative	No
Secondary	American Orthopaedic Foot and Ankle Society- Ankle and Hindfoot Score		pre operation; 3, 6, 12 month post operation	No