1. Use of OP1: present situation

1.1 Tibial pseudoarthrosis. The work by Friedlander can be considered golden standard about the clinical application. It is a prospective, randomized clinical trial comparing OP-1 with fresh bone autograft. Results of the two techniques are similar under the clinical and radiographical point of view(1). Some cases of very serious pseudoarthrosis treated with OP1 have demonstrated an high percentual of clinical recovery(2). In the I Orthopaedic Clinic of Turin University pseudoarthrosis are treated with Ilizarov technique, not with the autologous transplantation, so Friedlander’s results are not discriminant for the our work.

1.2 Australian study of 163 patients with amputation risk was done an attempt with OP1 application, before of his commercialisation. In these cases the drug demonstrated to be very efficacious(3).

1.3 Concerning the fresh fractures, experience is limited to prospective, randomised, multicenter clinical trial. The conclusions are a reduction of consolidation delay and the number of reoperation in the OP1 treated group versus the not treated one(4).

2. In the I Orthopaedic Clinic of Turin University (UOSD Muscle-Skeletal Traumatology and External Fixation) guide lines for OP1 application are:

2.1 Delayed union of the docking point in pseudoar-throsis of long bones treated with the Ilizarov technique. OP1 is also used if traditional techniques are not suitable for application

2.2 Traditional techniques failure

2.3 First treatment in very difficult cases of limb reconstruction and bone nonunion

3. From 30/09/2002 till 27/09/2004, 19 patients have been treated with OP1. Middle age is 38 years (range 22–65). Before last intervention, middle number of operation is 6,5 (range 3–26) with middle time treatment of 4 years (range 1–31). 12 healed, 5 are under treatment and 2 are failure (osteomyelitis relapse). 10 tibias, 7 femurs, 1 humerus and 1 forearm were treated. The middle time of healing was 4 months (range 2–6).

Healing has been evaluated by clinical and radiographical point of view (handly evaluation of stability, function recuperation and image of bone consolidation). Radiographic images of bone consolidation are not strictly correlated with clinical stability and function recovery.

4. Conclusion:

4.1 The series is strictly observational. However results are satisfying, given the complexity of treated cases. More prospective randomised double blind clinical studies, and drug cost decrease are necessary to extend the indications for OP1 application.