INTRODUCTION The human skull is a unique bony structure that plays an essential role in the distinctive appearance of an individual. It also acts as a protective vault for the central nervous system. However, this sophisticated structure can be disrupted by multiple disease processes, such as trauma and malignancies, which lead to cranial defects. Every year, approximately 69 million individuals worldwide suffer from traumatic head injuries, which represent an enormous economic burden on medical services [1], and the foremost cause of death and disability [2] Skull bone defects can be caused by trauma, infection of the calvarial bone, and craniectomy for cerebral decompression procedures, and can result in cosmetic or functional problems. This loss of bone compromises the skull’s function as a brain guard and leaves the brain vulnerable to further physical trauma [3]. In addition, the absence of a sizeable calvarial bone results in several physiological and psychological complications. The skull shape contributes significantly to physical appearance (i.e. any defect in this area will result in extreme disfigurement). Pruzinsky illustrated that individuals with major craniofacial abnormalities might experience social withdrawal and develop psychological and emotional distress [4]. Among the other complications of absent cranial bony coverage is the ‘syndrome of trephine’, described in 1939 by Grant and Norcross.6 Patients experience a cluster of symptoms, including headache, insomnia, behavioural changes, vertigo, tinnitus and fatigue [5,6]. The ‘sinking scalp flap syndrome’ has also been used to describe focal motor deficits in patients who undergo craniectomy and have a persistent hemi-cranial defect. It is also known as motor trephine syndrome [7]. Due to the many complications of cranial defects, cranial reconstruction is performed. Cranioplasty is a critical surgical intervention performed to repair cranial defects following trauma or neurosurgical procedures. Materials utilized for cranial reconstruction include bone, auto/allografts, distinct biomaterials, and osteoinductive growth factors. Several alloplastic materials have recently been suggested for use as replaceable substitutes when there is a skull defect [8]. In trauma cases, natural bone is not always available for reconstruction due to factors like bone loss, severe fractures, or infection. This limitation makes the use of alloplastic materials highly advantageous in cranioplasty. These materials, such as polymethyl methacrylate (PMMA), hydroxyapatite, polyetheretherketone (PEEK), and metallic mesh, offer effective and reliable alternatives for cranial reconstruction [9,10]. Over the last century, non-biological prostheses have become common for bone tissue repair. In early craniofacial surgeries, metals like silver, gold, and titanium were widely used. However, metallic implants face issues such as stress shielding, corrosion, and cytotoxicity from ion release. Additionally, they interfere with imaging techniques, hindering post-operative monitoring. To address these issues, bioceramics like hydroxyapatite (HA) and tri-calcium phosphate (TCP) were explored due to their bioactivity and similarity to bone. However, their brittleness limits their use. Combining bioceramics with other materials and developing polymer-based implants like PEEK and PMMA offers advantages such as biocompatibility, mechanical strength, and radiolucency, facilitating better post-operative imaging. Moreover, the advent of digital design technologies has greatly simplified the process, allowing for precise, patient-specific implants. Digital tools have reduced the technical sensitivity of the procedure, enabling surgeons to create custom-fitted cranial implants that match the patient’s anatomy with greater accuracy and efficiency. Digital technologies have revolutionized the design and fabrication of cranial implants, offering precision and patient-specific solutions. However, the material used for cranial implants significantly impacts both the clinical and functional outcomes of the procedure. Commonly used materials such as titanium, polymethyl methacrylate (PMMA), and polyetheretherketone (PEEK) each present unique advantages and limitations in terms of biocompatibility, strength, and infection rates. This study aims to investigate the comparative effectiveness of various implant materials used in cranioplasty for patients with post-traumatic brain injury (TBI), specifically examining both clinical results and functional recovery outcomes. LITERATURE REVIEW Hamböck et al. (2020) conducted a study to evaluate the impact of implant materials and patient age on long-term outcomes following secondary cranioplasty in patients with severe traumatic brain injury. The study, emphasized the significance of implant material and age in determining clinical success, with titanium implants showing superior outcomes. This research addressed a critical gap in understanding the combined influence of patient-specific factors on cranioplasty outcomes. Kim et al. (2021), in their study examined predictive factors for surgical site infections (SSIs) after cranioplasty, including the use of 3D-printed implants. The study identified critical factors influencing infection rates and provided insights for improving implant design and surgical protocols. The findings highlighted the importance of patient-related factors and surgical techniques in minimizing SSIs and improving postoperative outcomes. Koller et al. (2020) performed a retrospective descriptive study comparing cranioplasty failure rates between novel 3D-printed calcium phosphate implants and traditional materials. The study revealed higher success rates and reduced complications with the 3D-printed implants, showcasing their potential as a viable alternative for cranial reconstruction. This work underscored the need for advancements in biomaterials and manufacturing techniques to optimize cranioplasty outcomes. Patra, Kale (Pisulkar), and Iratwar (2021) conducted an observational study on the clinical outcomes of cranioplasty using various prosthetic materials in traumatic brain injury patients. The research analyzed the performance of different materials, emphasizing the role of material properties in postoperative success. The study contributed to the growing body of evidence supporting the importance of personalized material selection in cranioplasty. Yang et al. (2019) designed a protocol for a multicenter, assessor-blinded, randomized controlled trial to compare titanium mesh and polyetheretherketone (PEEK) cranioplasty. The study aims to evaluate the clinical effectiveness, safety, and patient satisfaction associated with these two commonly used materials. This trial is expected to provide high-quality evidence for material selection in cranioplasty, addressing a significant gap in clinical practice guidelines. RESEARCH GAP Despite advances in digital design for cranial implants, there is limited research on the comparative effectiveness of different materials in terms of both clinical and functional outcomes in post-traumatic brain injury patients. Most studies focus on individual materials without comprehensive head-to-head comparisons or long-term evaluations of functional recovery and complication rates. RESEARCH QUESTION What are the comparative clinical, functional, and patient-reported outcomes in post-traumatic brain injury patients undergoing cranioplasty using digitally fabricated cranial implants made from different materials such as titanium, PMMA, and PEEK? How do the clinical, functional, and patient-reported outcomes compare among post-traumatic brain injury patients undergoing cranioplasty with digitally fabricated cranial implants made from titanium, PMMA, and PEEK materials?" HYPOTHESIS – There will be significant differences in clinical, functional and patient reported outcomes among patients receiving cranial implants made from different materials (titanium, PMMA, and PEEK) in cranioplasty procedures. Specifically, it is hypothesized that at least one material will demonstrate superior outcomes regarding post-operative complications, functional recovery, and overall patient satisfaction. Additionally, the implementation of digitally designed, patient-specific implants is expected to enhance surgical results across all material types. AIM To compare the clinical, functional and patient reported outcomes of digitally designed cranial implants made from different materials (titanium, PMMA, and PEEK) in cranioplasty for patients with post-traumatic brain injuries. OBJECTIVES 1. To assess infection rates, implant failure, and overall clinical success of cranioplasty performed with different implant materials (titanium, PMMA, and PEEK), evaluated postoperatively at 1-, 3-, and 6-months using CT scan imaging. 2. To evaluate the neurological and functional recovery of patients undergoing cranioplasty with titanium, PMMA, and PEEK implants, employing validated assessment tools; the Glasgow Coma Scale (GCS) and the Functional Independence Measure (FIM) during postoperative assessments at 1, 3, and 6 months. 3. To examine patient-reported outcomes related to quality of life and satisfaction following cranioplasty, utilizing validated measures; the SF-36 Quality of Life Questionnaire (SFQOL36) at postoperative intervals of 1, 3, and 6 months. 4. To compare the clinical and functional outcomes of cranioplasty across the three implant materials—titanium, PMMA, and PEEK—during postoperative evaluations at 1, 3, and 6 months. STUDY TYPE/DESIGN A randomized controlled trial comparing three different cranial implant materials (titanium, PMMA, and PEEK). INCLUSION AND EXCLUSION - Inclusion Criteria: · Patients aged 18 to 45 years who have cranial defect larger than 3 cm in diameter; resulting from traumatic brain injury and require cranioplasty. · No previous history of infection at the site designated for cranioplasty. · Patients with stable medical conditions and no contraindications for surgery or the materials used. · Patients who are willing to participate in the study and provide informed consent. Exclusion Criteria: · Patients unfit for cranioplasty · Patients presenting with infection before cranioplasty · Patients with prior cranial surgeries using non-customized implants. STUDY SITE The study will be conducted at the Department of Neurosurgery, AVBRH, Sawangi (M) Wardha. SAMPLE SIZE - STUDY PARTICIPANTS - Participants will include male and female patients who have sustained traumatic brain injuries and require cranioplasty for the repair of cranial defects. Each participant will be randomly assigned to one of three implant material groups (titanium, PMMA, or PEEK). Polymethylmethacrylate (PMMA Implant ) |
MATERIAL WITH STANDARDIZATION- The materials utilized for the implants will include titanium, PMMA, and PEEK. METHDOLOLOGY WITH JUSTIFICATION- Each cranioplasty procedure will be performed by experienced neurosurgeons at the Department of Neurosurgery, AVBRH Hospital, Sawangi (M) Wardha. Clinical information will be gathered from patients or their family members after obtaining written informed consent. Ethical approval for the study will be obtained from the Institutional Ethics Committee prior to its commencement. · Preoperative Assessment: Thin-slice computed tomography (CT) scans and 3-dimensional cranial reconstructions will be performed for each patient with skull defects to gather detailed anatomical data. · Implant Fabrication: Customized cranial implants made of titanium (Ti), PEEK, or PMMA will be manufactured by specialized company based on the radiographic data obtained from the preoperative scans. · Implant Placement: Once the implant is placed at the surgical site, it will be secured to the peripheral calvarial bone using either a PEEK connector or titanium screws. A subcutaneous drain with negative-pressure suction will be placed for two days post-surgery to manage fluid accumulation and aid in the healing process. I. Evaluation of clinical outcome: Clinical outcomes will be assessed by monitoring postoperative parameters; wound healing, infection rate, implant stability, and complications (e.g., implant rejection or resorption). Evaluation will be done by physical examination and CT scan imaging to ensure implant integration and stability. The data will be collected during follow-up visits at 1-, 3-, and 6-months post-surgery for patients in all three groups. II. Evaluation of functional outcome: Functional outcomes will be assessed using neurological scales; the Glasgow Outcome Scale (GOS), and the Functional Independence Measure (FIM), to evaluate cognitive, motor, and overall functional recovery. Baseline preoperative data will be collected and compared with postoperative results at 1, 3, and 6 months to analyse improvements in functional status and recovery in patients undergoing cranioplasty for all three groups. III. Evaluation of patient reported outcome: Patient-reported outcomes will be assessed using the validated SF-36 (Short Form Health Survey) questionnaire to evaluate quality of life, comfort, and aesthetic satisfaction with the cranial implant. Surveys will be conducted preoperatively as a baseline and at 1, 3, and 6 months postoperatively to measure improvements in patient-perceived outcomes. IV. Comparison of clinical, functional and patient reported outcome for different materials: To objectively assess the three materials used in the study, comparative analysis will be made using clinical case data and postoperative follow-up information collected at 1, 3, and 6 months. FLOWCHART KNOWLEDGE GENERATION (IN ANTICIPATION)- This study will generate new insights into the comparative clinical performance and functional outcomes associated with different cranial implant materials. The findings could guide surgeons in choosing the optimal material for cranioplasty in post-traumatic brain injury patients, improving long-term outcomes and patient satisfaction. TRANSLATORY COMPONENT (CONCEPTUALIZED) The findings of this study have the potential to significantly influence future guidelines for material selection in cranioplasty by systematically comparing the clinical and functional outcomes of titanium, PMMA, and PEEK implants. This research aims to provide robust evidence to guide clinicians in choosing the most effective materials for individual patients, ensuring that treatment decisions are informed by solid clinical data. Furthermore, the study could encourage the adoption of advanced, patient-specific cranial implants tailored to each patient’s unique anatomy, optimizing surgical outcomes through customized solutions. Additionally, the insights gained from this research may facilitate collaborations with medical device manufacturers to refine digital design technologies and integrate cutting-edge manufacturing processes into clinical practice. This could lead to the creation of more effective and easily producible implants, while also developing comprehensive patient-specific treatment protocols that consider individual anatomy and injury severity. Ultimately, the translational component of this study aims to bridge the gap between research and clinical practice, enhancing the standard of care in neurosurgery and improving long-term patient outcomes.
|