Backfill for iliac-crest donor sites: a prospective, randomized study of coralline hydroxyapatite.

We report on a prospective randomized study of coralline hydroxyapatite (CH) used as backfill for iliac-crest donor sites. Autogenous iliac-crest bone graft is routinely harvested for spinal fusion. Donor-site morbidity is underappreciated; the presumption is that donor sites regenerate. In this study, we assessed the biological viability of the backfill CH (Pro OsteonTM Implant 500 Hydroxyapatite Bone Void Filler; Interpore, Irvine, Calif) and compared donor-site morbidity after harvest. Twelve patients (11 men, 1 woman) were enrolled: 5 in the backfill group and 7 in the no-backfill group. As part of routine evaluations done preoperatively and 6 weeks, 3 months, 6 months, and 1 year postoperatively, plain radiographs and computed tomography (CT) scans were used to assess bone ingrowth, and technetium bone scans were used to assess biological activity. Postoperative pain analysis was also done. Ten patients (9 men, 1 woman) completed the study. Of the 4 completers in the backfill group, 3 (75%) showed bony ingrowth on plain radiographs and CT scans at 1 year; the fourth patient showed bony ingrowth only on plain radiographs. All 4 patients showed biological activity on bone scans and reported mild pain to no pain. Of the 6 completers in the no-backfill group, 1 (17%) showed bony ingrowth on plain radiographs and CT scans. No patient showed biological activity on bone scans at 1 year. CH aids in iliac-crest healing after bone-graft harvesting by acting as a biological osteoconductive matrix. Postoperative pain at the bone-graft site is potentially reduced. More studies of larger numbers of patients are needed to assess the true long-term benefits of this material in a clinical setting.

RCT Entities:   Population Interventions Outcomes