ApaTech is touting positive results for a pair of clinical trials of its Actifuse synthetic bone graft that it says indicate the product is as good or better than iliac bone crest grafts for spinal fusion procedures.
The orthobiologics maker, which has its United States headquarters in Foxborough, said the first study, of 38 patients with lumbar stenosis, showed that patients who underwent spinal fusion procedures using the product experienced a fusion rate of 81 percent and a 68 percent reduction in post-operative pain after two years. Ninety-five percent of patients reported good or excellent satisfaction results.
The second study, of 69 patients with degenerative lumbar spine disease who underwent spinal fusions using Actifuse, showed that 81 percent had radiographic evidence of bridging bone growth a year after surgery. Fifty-seven percent of patients said their back pain was relieved and 67 percent said their leg pain got better.
The authors of both studies concluded that the procedures with Actifuse offered good alternatives to standard ICBG treatments, according to the company.
In iliac crest bone grafts, bone from patients’ hips is taken to use as a graft to fuse vertebrae. The Actifuse product is a silicon-based orthobiologic agent that stimulates bone growth.
