European Journal of Cardiovascular Medicine

Cranioplasty is a neurosurgical procedure aimed at restoring the contour, integrity, and protective function of the skull following decompressive craniectomy (DC), a life-saving intervention often required for patients with raised intracranial pressure secondary to traumatic brain injury (TBI), malignant middle cerebral artery (MCA) infarctions, subdural hematomas (SDH), or intracerebral hemorrhage (ICH) [1,2]. The indications for decompressive craniectomy have expanded significantly, with DC being widely adopted for refractory intracranial hypertension management [3].

While cranioplasty is considered a secondary reconstructive step, it holds substantial therapeutic significance. Beyond cosmetic restoration, it contributes to improved cerebral hemodynamics, cerebrospinal fluid (CSF) dynamics, metabolic regulation, and neurological recovery [4–6]. However, the optimal timing of cranioplasty remains a subject of ongoing debate. Early cranioplasty (typically within 3 months of DC) may facilitate earlier neurological rehabilitation and reduce complication rates such as hydrocephalus and syndrome of the trephined [7–9]. Conversely, delayed or late cranioplasty (beyond 3 months) is often preferred in cases with infection risk, poor wound healing, or unresolved cerebral edema, though it may be associated with prolonged operative time, increased blood loss, and suboptimal cognitive recovery [10,11].

Several studies have attempted to elucidate the effect of cranioplasty timing on outcomes such as operative time, intraoperative blood loss, postoperative complications, and functional neurological improvement [12,13]. Nonetheless, findings have been inconsistent, and most studies have lacked uniform criteria for defining “early” versus “late” intervention. Furthermore, standardized tools for assessing neurological outcomes—such as the Glasgow Coma Scale (GCS), Glasgow Outcome Scale (GOS), Mini-Mental State Examination (MMSE), and Barthel Index (BI)—have not been consistently applied across studies [14].

This prospective comparative study aims to evaluate the impact of timing of cranioplasty (early vs. late) on key intraoperative parameters (blood loss, operative time), postoperative recovery (hospital stay, complications), and neurological function, using validated assessment tools. The goal is to provide evidence-based guidance on the ideal timing of cranioplasty to optimize both surgical and neurological outcomes.

Study Design

This was a prospective, comparative, single-institutional study conducted between January 2020 and June 2021 in the Department of Neurosurgery at G. R. Medical College and J.A. Group of Hospitals, Gwalior (Madhya Pradesh), India, a recognized tertiary care center. The study was approved by the Institutional Ethics Committee, and written informed consent was obtained from all participants prior to enrollment.

Sample Size

A total of 30 patients undergoing cranioplasty were included in the study. These were equally divided into two groups:

• Early Cranioplasty Group (n = 15): Underwent cranioplasty within 3 months of decompressive craniectomy.
• Late Cranioplasty Group (n = 15): Underwent cranioplasty after 3 months of decompressive craniectomy.

Inclusion Criteria

Patients with craniectomy defects secondary to raised intracranial pressure due to conditions such as:

1. Traumatic Brain Injury (TBI)
2. Intracerebral Hematoma (ICH)
3. Subdural Hematoma (SDH)
4. Ischemic Stroke

Exclusion Criteria

1. Craniectomy defects following tumor surgery or infected bone flap.
2. Patients unwilling to undergo cranioplasty surgery.

Data Collection and Clinical Assessment

Demographic and clinical data were collected, including:

1. Age, sex, laterality of craniectomy, and indication for decompressive craniectomy
2. Neurological assessments were conducted at admission and at 3-month follow-up using:
3. Glasgow Coma Scale (GCS)
4. Glasgow Outcome Scale (GOS)
5. Mini-Mental State Examination (MMSE)
6. Barthel Index (BI)

Intraoperative and Postoperative Parameters

• Blood loss was estimated by counting soaked gauze pads (each gauze assumed to hold 8–10 mL blood), measuring suction container contents (excluding saline), and postoperative drain output.
  • Operative time was recorded from incision to closure.
  • Hospital stay was calculated from the day of cranioplasty to discharge.
  • Postoperative CT scans were performed in all cases to assess cranioplasty site integrity and complications.

All patients were followed up for 3 months to evaluate neurological recovery and detect complications such as hydrocephalus, seizures, subdural hematoma, or delayed infection.

Operative Technique

Standard surgical technique was followed for all patients:

• Preoperative antibiotics were administered.
• Incisions followed previous scars to preserve scalp vascularity.
• Scar tissue dissection was performed carefully to avoid dural injury.
• Cranioplasty was performed using one of the following materials:

Autologous bone flap (preserved in the abdominal subcutaneous layer)

Methyl methacrylate

Titanium mesh

In cases with persistent cerebral herniation, intraoperative CSF drainage or ventriculoperitoneal shunt placement was considered. Implants were fixed using titanium plates and screws. Subgaleal drains were placed in all cases.

Cranioplasty Materials

-        Autologous Bone Flap: Harvested from the abdomen, washed with betadine and hydrogen peroxide, and reused.

-        Methyl Methacrylate: Molded intraoperatively using vacuum mixing systems; care taken to prevent overheating and ensure proper fit.

-        Titanium Mesh: Preformed or contoured intraoperatively; secured using standard hardware.

Scoring Scales Used

• Glasgow Coma Scale (GCS): Assessed eye, verbal, and motor responses.
• Glasgow Outcome Scale (GOS): Ranged from death to good recovery.
• Barthel Index (BI): Evaluated independence in activities of daily living.
• Mini-Mental State Examination (MMSE): Measured cognitive function out of a maximum score of 30.

Statistical Analysis

Data were analyzed using SPSS version 20.0. A p-value < 0.05 was considered statistically significant.

• Unpaired t-test was used to compare outcomes between the two groups.
• Paired t-test was used to compare admission and follow-up scores within the same group.
• Pearson correlation test was used to assess associations between clinical parameters.

Table 1: Gender-wise Distribution of Patients

Observation: Male predominance, particularly in the late cranioplasty group, reflects higher risk of traumatic injuries among males due to increased involvement in outdoor and vehicular activities.

Table 2: Age Distribution

Table 3: Age Group Distribution

Table 4: Indications for Decompressive Craniectomy

Table 5: Material Used for Cranioplasty

Table 6: Dural Tear Incidence

Table 7: Operative Time

Table 8: Hospital Stay

1. Duration (Days)

1. Mean Hospital Stay

Table 9: Blood Loss

Table 10: Post-operative Complications

Table 11: Functional Outcome Scores

Barthel Index (BI)

MMSE Score

GCS Score

GOS Score

Table 12: Statistical Significance (Unpaired t-test)

*Statistically significant (p < 0.05)

Cranioplasty following decompressive craniectomy (DC) is more than a cosmetic procedure; it plays a pivotal role in restoring cerebral physiology, improving neurological function, and preventing complications such as sinking skin flap syndrome and hydrocephalus [1,2]. The timing of cranioplasty—whether performed early (within 3 months) or late (after 3 months)—has been an area of active investigation due to its potential impact on surgical morbidity, recovery time, and long-term outcomes.

In the present study, early cranioplasty (n = 15) was associated with significantly lower operative time (1.23 ± 0.26 hrs vs. 2.07 ± 0.65 hrs; p < 0.05), blood loss (209.33 ± 33.48 mL vs. 346.67 ± 44.51 mL; p < 0.05), and hospital stay (8.67 ± 2.94 days vs. 12.07 ± 3.10 days; p < 0.05) compared to the late cranioplasty group. These findings are consistent with prior reports, which suggest that delayed cranioplasty is associated with more extensive scarring, dural adherence, and brain tissue retraction—making surgical dissection more challenging and increasing the risk of dural tears and bleeding [3,4].

In our study, the incidence of dural tears was markedly higher in the late group (33.3% vs. 6.7%), reaffirming that surgical complexity increases over time due to fibrotic changes and scar maturation [5]. This mirrors results from Malcolm et al. [6], who observed increased operative complications with delayed intervention.

Regarding neurological outcomes, both groups demonstrated improvement across all functional scales (GCS, GOS, MMSE, and Barthel Index). However, the early cranioplasty group showed greater improvements at the 3-month follow-up, although statistical significance was not reached for most neurological parameters. This trend supports studies by Shahid et al. [7] and Di Stefano et al. [8], who reported earlier and more substantial cognitive recovery in patients undergoing early reconstruction due to restoration of cerebral blood flow and normalization of intracranial pressure dynamics.

Our findings also align with Stone et al. [9] and Xu et al. [10], who performed meta-analyses confirming that early cranioplasty leads to better functional outcomes and fewer complications in select patient populations. However, early cranioplasty must be cautiously considered in patients with unresolved cerebral edema, infection, or systemic instability—conditions where delayed intervention may be justified [11].

An important observation in our study was the difference in complication patterns. While infections were minimal in both groups, seizures were more frequent in the late group during follow-up (4 patients), although not statistically analyzed due to small sample size. Previous literature suggests that delayed cranioplasty may increase seizure risk due to prolonged cortical irritation and impaired autoregulation [12].

The choice of cranioplasty material also varied, with autologous bone being more common in the early group and bone cement more frequently used in the late group. This is expected, as prolonged storage of bone flaps (especially in the abdomen) can increase the risk of resorption or contamination, necessitating synthetic substitutes [13].

Despite the small sample size, our study reinforces the growing consensus that early cranioplasty (within 3 months) is generally safer, faster, and associated with improved early neurological recovery. The results emphasize the importance of individualized patient selection, adequate infection control, and standardized perioperative protocols to minimize risks regardless of timing.

This study demonstrates that early cranioplasty (within 3 months of decompressive craniectomy) is associated with significantly lower intraoperative blood loss, shorter operative time, and reduced hospital stay compared to late cranioplasty. Although the differences in neurological outcome scores (GCS, GOS, MMSE, and Barthel Index) between the two groups were not statistically significant, early cranioplasty showed a trend toward better functional recovery. Additionally, the early group experienced fewer surgical complications, particularly dural tears.

These findings suggest that, in the absence of contraindications such as infection or unresolved cerebral edema, early cranioplasty is a safe and effective strategy that may facilitate better surgical and neurological outcomes. Timing should be individualized based on patient condition, but early reconstruction can be considered favorable in most clinical scenarios

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