Effectiveness of recombinant human bone morphogenetic protein-7 in the management of congenital pseudoarthrosis of the tibia: a randomised controlled trial.
OBJECTIVE
Despite the popularity and an increased use of bone morphogenetic protein to improve bone healing in patients with congenital pseudoarthrosis of the tibia (CPT), no previous study has compared its efficacy against any other procedure.


METHODS
We randomised 20 consecutive patients (mean age 4.1 years) with CPT (Crawford type IV) associated with neurofibromatosis type 1(NF1) and no previous history of surgery into two groups. Group 1 received recombinant human bone morphogenetic protein-7 (rhBMP-7) along with intramedullary Kirschner (K)-wire fixation and autologous bone grafting; group 2 received only K wire and grafting. Outcome measures were time to achieve union, Johnston grade, tibial length and the American Orthopaedic Foot and Ankle Society (AOFAS) score, which were evaluated preoperatively and at five year follow-up.


RESULTS
Study results showed that patients in group 1 achieved primary bone union at a mean of 14.5 months [standard error (SE) 5.2], whereas group 2 took a mean of 17.11 months (SE 5.0). However, the log-rank test showed no difference in healing times between groups at all time points (P = 0.636). There was a statistically significant pre- to post operative improvement (P < 0.05) within groups for the other outcome measures.


CONCLUSIONS
In a five year follow-up, these results suggest that rh-BMP-7 and autologous bone grafting is no better than autologous grafting alone.
Department of PM&R, SVNIRTAR, Olatpur, P.O.Bairoi, Cuttack Dt., Odisha, 754010, India, sakti2663@yahoo.com.
Sakti Prasad
SP
Das
Shankar
S
Ganesh
Sudhakar
S
Pradhan
Deepak
D
Singh
Ram Narayan
RN
Mohanty
D055419:Bone Morphogenetic Protein 7 / Q000627:therapeutic use*; D016025:Bone Transplantation / Q000379:methods*; D001864:Bone Wires; D002648:Child; D002675:Child, Preschool; D005260:Female; D005500:Follow-Up Studies; D005592:Fracture Fixation / Q000295:instrumentation / Q000379:methods; D017102:Fracture Healing / Q000187:drug effects; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D011446:Prospective Studies; D011542:Pseudarthrosis / Q000151:congenital* / Q000628:therapy*; D011994:Recombinant Proteins / Q000627:therapeutic use; D013978:Tibial Fractures / Q000151:congenital* / Q000628:therapy*; D016896:Treatment Outcome
D055419:Bone Morphogenetic Protein 7; D011994:Recombinant Proteins