Clinical Studies of Anterior Cervical Fusion with PEEK Cages: Comparing Iliac Graft and a Macroporous Biphasic Calcium Phosphate

Abstract:

The objective of the study was to compare clinical efficiency of the fusion after reconstruction with an anatomically shaped PEEK cage associated with a iliac crest autograft or MBCP in the treatment of cervical disc disease in randomized clinical trial. A multicente randomized, comparative and prospective study on 58 patients, with a 12 months follow up are reported. They underwent anterior cervical decompression and fusion being randomized for autologous graft or MBCP. Patients presenting purely degenerative disc disease were implanted with a PEEK cage filled with iliac crest autograft or MBCP. Pain and functionality as well as patients satisfaction were assessed through VAS, Neck Disability Index (NDI) and Patient Satisfaction index were recorded until 24 month follow-up. Radiological evaluation included plain and dynamic short X-rays at each stage of the follow up. The patients satisfaction rates was of 82% in the autograft group versus 96% in the MBCP group. Pain at the donor site was significantly more important in the autograft group at 3 weeks, 3 months and 1 year follow-up. No implant failures were recorded. Previously goat preclinical study was performed. Micro CT, light microscopy and shistomorphometry were related to the high performance of the MBCP insert for filling cage fusion, completing the clinical assessment of our clinical study. The use of MBCP insert is safe and avoids potential graft site morbidity and pain in comparison with an autologous graft procedure.

• Periodical: Key Engineering Materials (Volumes 529-530)
• Pages: 261-265
• DOI: https://doi.org/10.4028/www.scientific.net/KEM.529-530.261
• Online since: November 2012
• Authors: Guy Daculsi, H. Pascal-Moussellard
• Keywords: Biphasic Calcium Phosphate (BCP), Cervical Fusion Cage, Clinical Study, Insert, Micro Macroporous

References

[1] A.O. Ransford et al., J Bone Joint Surg Br 80(1) (1998) 13-18.

[2] R. Cavagna et al., Med Impl 9 (1999) 403-412.

[3] J . Delecrin et al., Spine 25 (2000) 563-569.

[4] T. Shima et al., J. Neurosurg. 51 (1979) 533-538.

[5] J.M. Toth et al., Spine 20(20) (1995) 2203-2210.

[6] D.Y. Cho, Surgical Neurology 63 (2005) 497-504.

[7] H.C. Chuang, Surgical Neurology 65 (2006) 464-471.

[8] Pascal Mousselard H. Biomatériaux et cages cervicales, PhD bthesis, Nantes University, (2004).

[9] Pascal-Mousselard et al., Les cages intervertébrales cervicales: analyse critique de la littérature. 2005, 147: 8-17.