Ultra-Early Cranioplasty versus Conventional Cranioplasty: A Retrospective Cohort Study at an Academic Level 1 Trauma Center.
Akal Sethi, Keanu Chee, Alia Kaakani...
https://pubmed.ncbi.nlm.nih.gov/36060455/Actively Recruiting
Led by Thomas Jefferson University · Updated on 2025-07-23
44
Participants Needed
1
Research Sites
N/A
Total Duration
This research aims to evaluate how the timing of cranioplasty affects postoperative complications and long-term recovery in patients who have undergone decompressive hemicraniectomy DHC due to acute traumatic injury, stroke, or intracranial hemorrhage. The study compares early cranioplasty performed within 8 weeks after DHC with the standard of care cranioplasty done after 3 months. It focuses on rates of complications such as infection, seizures, need for additional surgeries, and ventriculoperitoneal shunting. Participants are randomly assigned to receive either early cranioplasty or standard delayed cranioplasty following their initial DHC. Early cranioplasty is defined as the skull restoration surgery done within 8 weeks post-DHC, while the standard group undergoes the procedure after at least 3 months. Both procedures aim to restore the skull after DHC, which is a life-saving surgery to relieve brain pressure. During the study, researchers will assess functional outcomes at 6 and 12 months after DHC, examining neurological recovery, cognitive function, and quality of life. They will also monitor short-term complications such as seizures, hydrocephalus, infections, hospital length of stay, readmissions, and any returns to the operating room. Participants may be followed for up to a year to fully understand the effects of cranioplasty timing on recovery and complications.
CONDITIONS
Timing Impact of Early vs. Late Cranioplasty on Hemicraniectomy Outcomes
P
Pious Patel, MD
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Thomas Jefferson University
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Early cranioplasty (≤8 weeks after hemicraniectomy) | Standard-of-care cranioplasty (after 3 months) |
|---|---|---|
| What it is | Surgical restoration of the skull (cranioplasty) is performed within 8 weeks after decompressive hemicraniectomy to address acute cranial injuries. | The surgical procedure (cranioplasty) is carried out after a minimum of 3 months following decompressive hemicraniectomy for acute brain injury. |
| Role in the trial | Participants randomized to receive the skull repair within 8 weeks after their initial life-saving surgery. | Participants randomized to undergo cranioplasty no earlier than 3 months after their initial brain surgery. |
| Primary use | Restoring skull integrity and appearance after critical decompressive surgery, with intent to improve neurological outcome and protection. | Restoration of cranial defect at a later stage after stabilization, aiming for functional and protective benefits. |
| How it is performed | Cranioplasty is conducted surgically under general anesthesia within 8 weeks, following assessment of skull shape and patient medical condition. | Surgery under general anesthesia is done at or after 3 months, once infection risks are minimized and the patient is deemed ready for delayed reconstruction. |
| Evidence status | Published studies, including systematic reviews, suggest early cranioplasty can result in greater neurological improvement but may have increased risk for certain complications. | Delayed cranioplasty is supported by current practice and literature, aiming to allow full stabilization but may be associated with slower or less pronounced neurologic recovery. |
| Important risks | Risks include surgical site infection, seizures, hydrocephalus, and need for reoperation; some studies suggest the possibility of higher complication rates if done too early. | Delayed timing is associated with lower early-infection risk but can increase duration of skull defect and related complications; late performance is not free from surgical risks. |
| Important limitations | Optimal timing is still debated; patient selection, infection risk, and early post-injury complications can vary, and high-quality prospective evidence remains limited. | Delaying cranioplasty provides a stable clinical window but may slow neurological recovery, and individual patient factors may warrant earlier intervention. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants undergo cranioplasty surgery either early (within 8 weeks after decompressive hemicraniectomy) or as standard care (after 3 months).
1 surgery visit
Duration - Up to 12 months
Participants are monitored for postoperative complications and functional outcomes after cranioplasty.
Multiple visits including assessments at 1 month, 6 months, and 12 months post-cranioplasty
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Akal Sethi, Keanu Chee, Alia Kaakani...
https://pubmed.ncbi.nlm.nih.gov/36060455/James G Malcolm, Rima S Rindler, Jason K Chu...
https://pubmed.ncbi.nlm.nih.gov/28419358/Jessica C Eaton, Madeline E Greil, Dominic Nistal...
https://pubmed.ncbi.nlm.nih.gov/35061995/Pious D Patel, Omaditya Khanna, M Reid Gooch...
https://pubmed.ncbi.nlm.nih.gov/37166197/Thomas Jefferson University
Lead Sponsor