An Observational Prospective Clinical Study for the Evaluation of a Collagen-Hydroxyapatite Composite Scaffold in Hip Revision Surgery

Abstract

One of the greatest challenges of hip revision surgery is the need to restore extensive bone loss by creating a stable reconstruction with long-term durability. The present observational, investigator-initiated prospective study was carried out to evaluate the clinical and radiological results of the use of a commercial biomimetic collagen–hydroxyapatite composite biomaterial (RegenOss) applied in hip revision surgery. Thirty-three patients who underwent hip revision were included in this study, and 29 received up to 2 years of follow-up. The acetabulum was reconstructed using an uncemented hemispherical shell both with or without an iliac fixation stem. Functional recovery was assessed according to the Harris Hip Score (HHS) at the pre-hospitalisation check-up, and at 6-, 12-, and 24-month follow-ups. Radiological evaluation consisting of X-ray analyses (6, 12, and 24 month follow-ups) and CT scan exams (within 10 weeks post-surgery and at 12-month follow-up) were performed to evaluate the reduction in bone defect and new bone regeneration. All the patients reported a complete recovery and a considerable improvement in functional outcome assessed by the HHS, which was significantly higher at all the follow-ups than at pre-hospitalisation. Moreover, radiological assessments revealed good scaffold integration. Overall, collected data suggest that RegenOss is a valid and safe alternative to restoring acetabular bone loss in revision hip arthroplasty.

Safety of a Porous Hydroxyapatite Bone Substitute in Orthopedics and Traumatology: A Multi-Centric Clinical Study

“…In agreement with the studies by the authors mentioned above, there is the work of Cimatti P. et al [ 22 ], which takes into consideration the use of these devices in hip revision surgery. The authors of this study performed a 2-year follow-up on 29 patients undergoing revision hip prosthesis surgery, using a collagen–hydroxyapatite composite biomaterial device for the management of bone loss at the acetabular level.…”

“Metal-bone” scaffold for accelerated peri-implant endosseous healing

“…However, intraoperatively, it is often observed that the original prosthesis remains intact, with complications primarily arising due to inadequate bonding between the prosthesis and surrounding bone tissue. Using new prostheses in revision surgery not only results in the wastage of medical materials but also imposes an economic burden on patients and their families ( Cimatti et al, 2022 ). Currently, there is no definitive research comparing the efficacy of retaining the original prosthesis versus using a new one in revision surgery.…”