Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter...

Area of Science:

• Maxillofacial Surgery
• Biomaterials Science
• Health Economics

Background:

• Biodegradable fixation systems offer potential advantages over traditional titanium implants by reducing the need for secondary removal surgeries, thereby minimizing patient discomfort and healthcare costs.
• Titanium plates are commonly used in maxillofacial reconstruction, but their removal can lead to additional surgical procedures and associated expenses.

Purpose of the Study:

• To conduct a cost-effectiveness comparison between biodegradable and titanium fixation systems in Maxillofacial surgery.
• To evaluate the economic and clinical outcomes of using biodegradable versus titanium implants for various maxillofacial procedures.

Main Methods:

• A multicenter randomized controlled trial (RCT) involving 230 patients undergoing procedures such as bilateral sagittal split osteotomy (BSSO), Le Fort-I osteotomy, or bi-maxillary osteotomy, as well as fracture treatments.
• Patients were randomized to either a titanium (KLS Martin) or a biodegradable (Inion CPS) fixation group.
• Cost analysis was performed from a societal perspective, with bone healing at 8 weeks and plate removal at 2 years as key health outcomes for the incremental cost-effectiveness ratio (ICER).

Main Results:

• A significant number of patients (25/117) randomized to the biodegradable group required intra-operative switching to the titanium system.
• Both Intention-To-Treat (ITT) and Treatment-Received (TR) analyses indicated superior health outcomes with titanium plates and screws.
• Cost-effectiveness varied between analyses: the TR analysis favored the biodegradable group, while the ITT analysis favored the titanium group due to the handling of intra-operative switches.

Conclusions:

• The titanium system is the preferable choice over the biodegradable system for routine maxillofacial procedures, including mandibular, Le Fort-I, and zygomatic fractures, as well as BSSO, Le Fort-I osteotomies, and bimaxillary osteotomies.
• Intra-operative switches from biodegradable to titanium systems influenced the cost-effectiveness results, highlighting the importance of considering treatment adherence and modifications.
• Titanium fixation demonstrates a more favorable cost-effectiveness profile in the standard treatment of complex maxillofacial reconstructions and trauma.