The osteoinductive properties of demineralised
bone matrix have been demonstrated in animal studies. However, its therapeutic
efficacy has yet to be proven in humans. The clinical properties
of AlloMatrix, an injectable calcium-based demineralised bone matrix
allograft, were studied in a prospective randomised study of 50
patients with an isolated unstable distal radial fracture treated
by reduction and Kirschner (K-) wire fixation. A total of 24 patients
were randomised to the graft group (13 men and 11 women, mean age
42.3 years (20 to 62)) and 26 to the no graft group (8 men and 18
women, mean age 45.0 years (17 to 69)). At one, three, six and nine weeks, and six and 12 months post-operatively,
patients underwent radiological evaluation, assessments for range
of movement, grip and pinch strength, and also completed the Disabilities
of Arm, Shoulder and Hand questionnaire. At one and six weeks and
one year post-operatively, bone mineral density evaluations of both
wrists were performed. No significant difference in wrist function and speed of recovery,
rate of union, complications or bone mineral density was found between
the two groups. The operating time was significantly higher in the
graft group (p = 0.004). Radiologically, the reduction parameters
remained similar in the two groups and all AlloMatrix extraosseous leakages
disappeared after nine weeks. This prospective randomised controlled trial did not demonstrate
a beneficial effect of AlloMatrix demineralised