A Novel Reconstruction Device for Osteonecrotic Femoral Head Efficacy Evaluation: A Randomized-controlled Feasibility Trial

Abstract

BackgroundNumerous surgical treatments to preserve hip replacements have several controversies and none of these procedures are universally accepted nor have compelling evidence for osteonecrosis of the femoral head (ONFH). With developing a novel approach osteonecrotic device surgical procedure to support the regeneration of necrotic bone and articular cartilage in vivo, this will be the first randomized-controlled feasibility study to determine its safety in ONFH patients in comparison to the core decompression surgical procedure.MethodA total of 20 patients were enrolled and randomized; 10 in the osteonecrotic device group and 10 in the core decompression group. After their baseline data has been collected and their surgical procedure has been completed, the following postoperative data are then continued to 6 weeks, 3 months, 6 months, one year, and two years’ before the start of their surgery. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and visual analogue scale (VAS) were collected. ResultsAll surgical procedures were performed uneventfully with no perioperative complications. Immediate pain relief in twenty patients of both groups were observed from WOMAC and VAS, however, the osteonecrotic device group had significantly lower scores throughout all periods of the follow up overall.ConclusionOsteonecrotic device procedure is a safe surgical procedure that can provide a minimally invasive endoscopic approach for direct visual examination to the lesion site. Trial registrationClinicaltrials.gov, NCT04103944. Registered 26 September 2019 - Retrospectively registered, https://clinicaltrials.gov/ct2/show/NCT04103944