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P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial

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Abstract

Treatment of non-unions and delayed unions often requires osteogenic material. Recently, a biomimetic bone matrix that simulates the cellular environment of hard tissue, identified as P-15, was introduced to the orthopaedic community. A total of 22 patients with mal-union or delayed union fractures was treated from June 2000 to October 2003 with P15- bone graft substitute (P15-BGS) in the site of fracture and mostly with internal fixation. Patients were examined by independent radiographic analysis. Assessment criteria included time elapsed until bone bridging and time to full consolidation. In addition, histological assessment of the callus was done at the time of recovery of metal implants in five patients. Full consolidation was achieved in 90% (20 out of 22) of the patients treated with P15-BGS. The average time for full consolidation was 4.2 months. Histological assessment of the fracture callus in five of the patients confirmed the positive clinical and radiographic results. P15-BGS appears to offer a safe, economical and clinically useful alternative to autograft in the repair of ununited fractures. These results compare favourably with those in the published literature as an alternative to autograft.

Résumé

le traitement des pseudarthroses ou des retards de consolidation nécessite le plus souvent l’utilisation de matériel ostéogénique. Récemment un nouveau composant stimulant l’environnement cellulaire osseux a été développé (P-15TM) et introduit en orthopédie. 22 patients présentant un retard de consolidation après fracture ont été traités entre juin 2000 et octobre 2003 avec ce substitut P15 (P15-BGS), implanté au niveau du site de la pseudarthrose et le plus souvent associé à une fixation interne. Les patients ont été évalués par une analyse radiographique indépendante. Les critères étudiés ont été le temps nécessaire à obtenir un pont d’ossification et le temps complet de la consolidation. De plus, une évaluation histologique du cal a été pratiquée chez 5 patients hospitalisés pour une ostéosynthèse secondaire. La consolidation complète a été obtenue dans 90% des cas (20 sur 22), patients traités avec P15-BGS. Le temps moyen de consolidation a été de 4,2 mois. Les examens histologiques chez ces 5 patients ont confirmé le bon résultat clinique et histologique. P15-BGS apparaît comme une possibilité relativement sûre, économique et utile cliniquement. Il s’agit d’une bonne alternative à l’autogreffe dans la réparation des pseudarthroses. Ces résultats comparés à la littérature confirment qu’il s’agit d’une alternative à l’autogreffe.

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Authors and Affiliations

  1. Department of Surgery, University of Valencia, El Bachiller 17, 46010, Valencia, Spain

    Francisco Gomar

  2. M.E. Muller Foundation, Barcelona, Spain

    Rafael Orozco

  3. Department of Orthopaedics, Hospital Santa María Madre, Orense, Spain

    Jose Luis Villar

  4. Polytechnical University, Madrid, Spain

    Federico Arrizabalaga

Authors
  1. Francisco Gomar
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  2. Rafael Orozco
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  3. Jose Luis Villar
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  4. Federico Arrizabalaga
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Correspondence to Francisco Gomar.

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Gomar, F., Orozco, R., Villar, J.L. et al. P-15 small peptide bone graft substitute in the treatment of non-unions and delayed union. A pilot clinical trial. International Orthopaedics (SICO 31, 93–99 (2007). https://doi.org/10.1007/s00264-006-0087-x

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  • DOI: https://doi.org/10.1007/s00264-006-0087-x

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