Skull defects after decompressive craniectomy due to traumatic brain injury or other intracranial diseases in patients undergoing first-time autologous cranioplasty, with emphasis on prevention of clinically relevant bone flap resorption (Oulu score =5) and associated cranial morphological changes.
Conditions
Interventions
Placebo group:Placebo (0.9% sodium chloride injection)
Zoledronic acid group:Zoledronic acid injection
Sponsors
Henan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Adults aged 18–70 years, regardless of sex; 2.Undergoing first-time autologous cranioplasty; 3.Presence of a unilateral skull defect; 4.Provision of written informed consent;
Exclusion criteria
Exclusion criteria: 1.Bone flap fragmentation into two or more pieces; 2.Preoperative intracranial infection; 3.Severe disorders of bone metabolism; 4.Presence of malignancy or receipt of immunosuppressive therapy; 5.History of prior bisphosphonate use; 6.Known hypersensitivity to bisphosphonates; 7.Renal insufficiency, defined as an eGFR <60 mL/min/1.73 m^2; 8.Pregnancy or lactation; 9.Hypocalcemia;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically relevant bone flap resorption rate at 24 months; | — |
Secondary
| Measure | Time frame |
|---|---|
| Oulu score;Continuous radiographic indicators (including bone flap thickness);Incidence, severity, and drug-relatedness of adverse events (AEs) and serious adverse events (SAEs);Time to revision/removal of the autologous bone flap;Acute-phase reactions: incidence and duration of fever and myalgia within 48 hours after infusion;Modified Rankin Scale (mRS) score;Any CTCAE grade =3 event;Laboratory safety indicators (including serum calcium, serum phosphorus, serum creatinine, and eGFR);Rate of revision/removal surgery related to the autologous bone flap;Bone flap resorption rate at each follow-up timepoint; | — |
Countries
China
Contacts
Public ContactRongjun Qian
Henan Provincial People's Hospital
Outcome results
None listed