Clinical Trial: Talar Avascular Necrosis: Surgical Angiogenesis vs. Core Decompression

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

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

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.

Detailed Summary:

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 befor
Sponsor: BG Trauma Center Ludwigshafen

Current Primary Outcome: Pain reduction [ Time Frame: pre operation; 3, 6, 12 months post operation ]

measured by visual anloge scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: BG Trauma Center Ludwigshafen

Dates:
Date Received: November 10, 2014
Date Started: February 2014
Date Completion: November 2016
Last Updated: November 12, 2014
Last Verified: November 2014