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

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

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.

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

Contacts and Locations

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:

• 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

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: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain reduction	measured by visual anloge scale	pre operation; 3, 6, 12 months post operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revascularization of the talus in the MRI	by ARCO-Criteria	6, 12 month post operation
Lower Extremity Functional Scale		pre operation; 3, 6, 12 month post operation
American Orthopaedic Foot and Ankle Society (AOFAS-) Ankle-Hindfoot-Score		pre operation; 3, 6, 12 month post operation

Collaborators and Investigators

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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

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

Study Registration Dates

• First Submitted: November 10, 2014
• First Submitted That Met QC Criteria: November 12, 2014
• First Posted (Estimate): November 13, 2014

Study Record Updates

• Last Update Posted (Estimate): November 13, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

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