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Safety, efficacy found for i-Factor bone graft in FDA IDE study
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Researchers of this multicenter pivotal FDA investigational device exemption trial found the i-Factor Bone Graft manufactured by Cerapedics Inc. met all four FDA-mandated non-inferiority success criteria, and demonstrated efficacy and safety in patients who underwent single-level anterior cervical discectomy and fusion for cervical radiculopathy.
Researchers conducted the prospective, randomized, controlled, multicenter clinical trial at 22 sites to investigate the safety and efficacy of the bone graft compared with autograft. They randomly placed patients into an autograft or i-Factor cohort. Patients then underwent a single-level anterior cervical discectomy and fusion (ACDF) for cervical radiculopathy. In total, 154 patients were placed in the autograft cohort and 165 were placed in the bone graft cohort. Study success was defined as non-inferiority in fusion, adverse events, neurological success endpoints and Neck Disability Index (NDI) scores at 12-month follow-up. Patients were evaluated preoperatively then postoperatively at 6 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and each year after that.
At 1-year follow-up, successful fusion was found in 88.9% of bone graft patients and 85.8% of autograft patients. Average NDI improvement was 28.7 and 27.4 in the bone graft and autograft groups, respectively. Neurological success was 93.71% in the bone graft cohort and 93% in the autograft cohort. Also, researchers found 83.64% of patients in the bone graft group had one or more adverse events compared with 82.47% of patients in the autograft group.
“To achieve overall success, a patient had to achieve success in all of the individual co-primary endpoints. i-Factor subjects demonstrated higher overall success rates compared with control subjects (68.75% and 56.94%, respectively, P = 0.0382). Improvement in VAS pain and SF-36v2 scores and [mental component summary] MCS scores was similar between i-Factor and autograft groups. There was no difference in improvement in the two groups relative to each other,” researchers wrote in the study. – by Robert Linnehan
Disclosures: Arnold reports no relevant financial disclosures. Please see the full study for a list of all other authors’ relevant financial disclosures.
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