Introduction: The COFLEX-F system was born to create vertebral arthrodesis inducing a block of movement in the articular district through the simple and safe positioning of the device between the spinous processes. The device features special perforated tabs that anchor firmly to the spinous process and by which you can enter dedicated rivets fastening the device in place. The main body has a characteristic shape of a "U" which allows the possible insertion of preformed bone substitute complex, creating a bone bridge between the spinous processes, lateral processes and posterior elements. In the study the bone substitute complex is composed bone substitute (Finceramica, Faenza, Italy), patient bone and hemotological elements.
Methods: 32 patients with lumbar stenosis (L1-L5)were enrolled from 1 June 2011 to 01 January 2013. The patients were subject to the following analyzes and questionnaires:
• The personal data and identification of the clinical picture of the patient.
• Descriptive data of the surgical procedure.
• VAS - pre-operative, post-operative, at six and twelve months .
• ODI - pre-operative, post-operative, at six and twelve months .
• CT scan - pre-operative, post-operative, six and twelve months.
Results: The results show at 18 month follow-up good outcome in 28 of the 32 patients clinically improved VAS and ODI scores.
Conclusions: The result obtained shows how the system COFLEX-F is capable of inducing an arthrodesis a very comparable to that obtainable with systems of pedicle screws and rods
In the light of the study in vitro and of the above considerations it is possible to assert that the use of the system COFLEX-F in combination of bone substitutes complex is from a biomechanical point of view vertebral arthrodesis with a clinical advantages for the patient and economically for the clinic.
Patient Care: Use of the system in combination of bone substitutes complex is a biomechanically proven vertebral arthrodesis with a clinical advantages for the patient outcome.
Learning Objectives: Identify an effective evaluation of the capacity of COFLEX-F to create a fusion at the operated level in combination of bone substitutes complex.
References: Biomechanical differences of Coflex-F and pedicle screw fixation combined with TLIF or ALIF--a finite element study.
Comput Methods Biomech Biomed Engin. 2011 Nov ;14(11):947-56. doi: 10.1080/10255842.2010.501762. Epub 2011 May 24 .