Evaluation of titanium cranioplasty and polyetheretherketone cranioplasty after decompressive craniectomy for traumatic brain injury: A prospective, multicenter, non-randomized controlled trial

INTRODUCTION: Cranioplasty following decompressive craniectomy is routinely performed to restore integrity of skull and improve neurological function. However, reconstructing the cranial defect brings many challenges to neurosurgeons and search for ideal implant materials is one of the most controversial issues. Although many studies have compared the outcomes of titanium and polyetheretherketone (PEEK) cranioplasty, yet no prospective study exists to guide the choice of titanium and PEEK materials. METHODS/DESIGN: A non-randomized, partially blinded, prospective cohort study is described that comprehensively compares the long-term outcomes of titanium cranioplasty versus PEEK cranioplasty. One hundred forty-five patients for each group will be recruited. Eligible patients are those with cranial defect due to traumatic brain injury (≥ 16 years), defect size is over 25 cm(2) and they must agree to participate in the trial. Each participant is evaluated before surgery, on discharge, 3, 6, and 12 months after cranioplasty. The primary outcome is the infection, implant failure and implant deformation requiring revision surgery within 12 months. Secondary outcomes include postoperative complication rate, neurological outcomes, motor function, and cosmetic outcome over a 6-month period. DISCUSSION: Search for ideal implant materials is throughout the history of cranioplasty. This study will provide robust evidence for the choice of cranioplasty materials. TRIAL REGISTRATION NUMBER: ChiCTR2000033406