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

Sponsor

BG Trauma Center Ludwigshafen (Other)

Overall Status

Unknown status

CT.gov ID

NCT02291900

Collaborator

(none)

Enrollment

Location

Arms

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 femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

Condition or Disease	Intervention/Treatment	Phase
Avascular Necrosis of Bone	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 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 Auto Grafting

Study Start Date :

Feb 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Nov 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Pain reduction [3, 6, 12 months post operation]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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 Chair: Ulrich Kneser, Phd, MD, BG Trauma Center Ludwigshafen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

BG Trauma Center Ludwigshafen

ClinicalTrials.gov Identifier:

NCT02291900

Other Study ID Numbers:

BGU - 01/14

First Posted:

Nov 17, 2014

Last Update Posted:

Nov 18, 2014

Last Verified:

Nov 1, 2014

Keywords provided by BG Trauma Center Ludwigshafen

avascular necrosis, talus, medial femoral condyle

Additional relevant MeSH terms:

Osteonecrosis

Necrosis

Study Results

No Results Posted as of Nov 18, 2014