Safety and performance of a novel synthetic biomimetic scaffold for iliac crest defect reconstruction during surgical treatment of pelvic girdle pain: a first-in-human trial.

Abstract

Introduction: Surgical treatment of pelvic girdle pain (PGP) involves arthrodesis of sacroiliac (SI) and pubic symphysis joints. Fusion of pubic symphysis involves the implantation of an autologous iliac crest tricortical graft harvested from the iliac crest. The objective was to assess the safety of a novel synthetic graft substitute (b.Bone) for iliac crest reconstruction and to evaluate the results of PGP surgical treatment.

Sources of data: Consecutive participants undergoing pelvic fusion and requiring iliac crest reconstruction were enrolled and followed-up for 12 months in a prospective first-in-human clinical investigation. Adverse events were documented, and health-related quality of life was evaluated using EuroQol-5D-5L questionnaire. Iliac crest defect healing was evaluated by the Modified Lane and Sandhu radiological scoring system. In addition, relevant published peer-reviewed scientific articles identified from PubMed.

Areas of agreement: The EQ-5D-5L scores improved steadily reaching the highest point at 365 days. By 365 days complete healing of the bone defect was observed.

Areas of controversy: The management of PGP remains challenging with mixed results reported in the literature.

Growing points: While there is lack of consensus on how to manage PGP, the present study shows improved outcomes at one year following surgery. The synthetic b.Bone scaffold is a safe option with good healing outcomes for iliac crest defect reconstruction.

Areas timely for developing research: Although b.Bone synthetic scaffold found to be safe, further studies reporting on surgical treatment of PGP are required to confirm the findings in comparative trials.