Study on the Effect of Ultra-early Autologous Cranioplasty on Neurological Function Recovery

NCT07183540 | Not Yet Recruiting DMC

• 1 other identifier: YE2025NW-140
• Study Type: interventional
• Target: 582
• Locations: 1 country
• Sites: 7

Brief Summary

To compare the neurological recovery and complication rate of autogenous cranioplasty(CP) within 6 weeks after decompressive craniectomy (DC) with that of autogenous cranioplasty within 3\~6 months after DC.

Conditions

Cranial Defect

Keywords

Decompressive craniectomy and Cranioplasty; operation opportunity; ultra-early; Autologous skull

Outcome Measures

Primary Outcomes (1)

• modified Rankin Scale (mRS) 0-2

  The proportion of patients with a modified Rankin Scale (mRS) score of ≤ 2

  at 180 (± 7) days

Secondary Outcomes (11)

• mRS≤2 and mRS ≤3

  90 (±7) days after CP

• mRS ≤3

  180 (±7) days after CP

• Mini-Mental State Examination (MMSE) score

  90 days (±7 days) and 180 days (±7 days) after CP surgery

• Glasgow Outcome Score (GOS)

  90 days (±7 days) and 180 days (±7 days) after CP surgery

• hydrocephalus or Cerebrospinal fluid shunt surgery rate

  90 days (±7 days) and 180 days (±7 days) after CP surgery

Other Outcomes (1)

• Overall mortality rate

  180 (±7) days after CP surgery

Study Arms (2)

experimental group

EXPERIMENTAL

The autologous skull repair surgery will be completed within 6 weeks after the DC operation.

Procedure: operation opportunity-within 6 weeks after the DC operation.

control group

ACTIVE COMPARATOR

The surgery should be completed within 90 to 180 days after DC.

Procedure: operation opportunity-within 90 to 180 days after the DC operation.

Interventions

operation opportunity-within 6 weeks after the DC operation. PROCEDURE

The autologous skull repair surgery will be completed within 6 weeks after the DC operation.

experimental group

operation opportunity-within 90 to 180 days after the DC operation. PROCEDURE

The autologous skull repair surgery should be completed within 90 to 180 days after DC.

control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Decompressive craniectomy due to craniocerebral trauma, cerebral ischemia and cerebral hemorrhage.
• Age 18 - 80 years.
• The first time for cranial repair.
• unilateral skull defect.
• Compliant with recommended decompressive bone flap surgery and autogenous decompressive bone flap after bone flap collection
• signed the informed consent.

You may not qualify if:

• Poor healing of skin flap (active infection, non-healing, necrosis, sinus, thin or poor blood supply, etc.).
• Fracture of bone flap ≥2 pieces, partial open fracture
• Intracranial infection before operation.
• Severe bone metabolic diseases.
• Long-term use of immunosuppressants.
• Pregnant or lactating women.
• Coagulation disorders.
• Severe cardiopulmonary insufficiency.
• It is estimated that the CP process cannot be completed within 6 weeks after the bone plate decompression surgery.
• Skull defect size less than 25cm².
• Life expectancy less than 1 year.
• mRS greater than 1 before primary disease.
• Diabetic patients.
• Patients who are unable to cooperate with follow-up assessment (e.g. mental illness).

Sponsors & Collaborators

• The Affiliated Hospital Of Guizhou Medical University: lead

Study Sites (7)

Anshun People's Hospital (Ward One)

Anshun, Guizhou, 561000, China

Location

Anshun People's Hospital (Ward Two)

Anshun, Guizhou, 561000, China

Location

The First People's Hospital of Bijie City

Bijie, Guizhou, China

Location

Guizhou Provincial Workers' Hospital

Guiyang, Guizhou, China

Location

Qianfengdong Prefecture People's Hospital

Kaili, Guizhou, China

Location

Zunyi Medical University Affiliated Hospital

Zunyi, Guizhou, China

Location

Neijiang First People's Hospital

Neijiang, Sichuan, China

Location

Related Publications (16)

• Morton RP, Abecassis IJ, Hanson JF, Barber JK, Chen M, Kelly CM, Nerva JD, Emerson SN, Ene CI, Levitt MR, Chowdhary MM, Ko AL, Chesnut RM. Timing of cranioplasty: a 10.75-year single-center analysis of 754 patients. J Neurosurg. 2018 Jun;128(6):1648-1652. doi: 10.3171/2016.11.JNS161917. Epub 2017 Aug 11.

  PMID: 28799868 BACKGROUND

• Eaton JC, Greil ME, Nistal D, Caldwell DJ, Robinson E, Aljuboori Z, Temkin N, Bonow RH, Chesnut RM. Complications associated with early cranioplasty for patients with traumatic brain injury: a 25-year single-center analysis. J Neurosurg. 2022 Jan 21;137(3):776-781. doi: 10.3171/2021.11.JNS211557. Print 2022 Sep 1.

  PMID: 35061995 BACKGROUND

• Mirabet V, Garcia D, Yague N, Larrea LR, Arbona C, Botella C. The storage of skull bone flaps for autologous cranioplasty: literature review. Cell Tissue Bank. 2021 Sep;22(3):355-367. doi: 10.1007/s10561-020-09897-2. Epub 2021 Jan 9.

  PMID: 33423107 BACKGROUND

• Piedra MP, Ragel BT, Dogan A, Coppa ND, Delashaw JB. Timing of cranioplasty after decompressive craniectomy for ischemic or hemorrhagic stroke. J Neurosurg. 2013 Jan;118(1):109-14. doi: 10.3171/2012.10.JNS121037. Epub 2012 Nov 9.

  PMID: 23140156 BACKGROUND

• Malcolm JG, Rindler RS, Chu JK, Chokshi F, Grossberg JA, Pradilla G, Ahmad FU. Early Cranioplasty is Associated with Greater Neurological Improvement: A Systematic Review and Meta-Analysis. Neurosurgery. 2018 Mar 1;82(3):278-288. doi: 10.1093/neuros/nyx182.

  PMID: 28419358 BACKGROUND

• Huang YH, Lee TC, Yang KY, Liao CC. Is timing of cranioplasty following posttraumatic craniectomy related to neurological outcome? Int J Surg. 2013;11(9):886-90. doi: 10.1016/j.ijsu.2013.07.013. Epub 2013 Aug 7.

  PMID: 23933129 BACKGROUND

• Yamada A, Imai K, Nomachi T, Fujimoto T, Sakamoto H, Kitano S. Cranial distraction for plagiocephaly: quantitative morphologic analyses of cranium using three-dimensional computed tomography and a life-size model. J Craniofac Surg. 2005 Jul;16(4):688-93. doi: 10.1097/01.scs.0000168995.27882.66.

  PMID: 16077318 BACKGROUND

• Hokugo A, Sawada Y, Sugimoto K, Fukuda A, Mushimoto K, Morita S, Tabata Y. Preparation of prefabricated vascularized bone graft with neoangiogenesis by combination of autologous tissue and biodegradable materials. Int J Oral Maxillofac Surg. 2006 Nov;35(11):1034-40. doi: 10.1016/j.ijom.2006.06.003. Epub 2006 Sep 11.

  PMID: 16965895 BACKGROUND

• Martin MP, Olson S. Post-operative complications with titanium mesh. J Clin Neurosci. 2009 Aug;16(8):1080-1. doi: 10.1016/j.jocn.2008.07.087. Epub 2009 May 7.

  PMID: 19427221 BACKGROUND

• Gooch MR, Gin GE, Kenning TJ, German JW. Complications of cranioplasty following decompressive craniectomy: analysis of 62 cases. Neurosurg Focus. 2009 Jun;26(6):E9. doi: 10.3171/2009.3.FOCUS0962.

  PMID: 19485722 BACKGROUND

• Taub PJ, Rudkin GH, Clearihue WJ 3rd, Miller TA. Prefabricated alloplastic implants for cranial defects. Plast Reconstr Surg. 2003 Mar;111(3):1233-40. doi: 10.1097/01.PRS.0000046048.77472.23. No abstract available.

  PMID: 12621197 BACKGROUND

• Lilja-Cyron A, Andresen M, Kelsen J, Andreasen TH, Fugleholm K, Juhler M. Long-Term Effect of Decompressive Craniectomy on Intracranial Pressure and Possible Implications for Intracranial Fluid Movements. Neurosurgery. 2020 Feb 1;86(2):231-240. doi: 10.1093/neuros/nyz049.

  PMID: 30768137 BACKGROUND

• Winkler PA, Stummer W, Linke R, Krishnan KG, Tatsch K. Influence of cranioplasty on postural blood flow regulation, cerebrovascular reserve capacity, and cerebral glucose metabolism. J Neurosurg. 2000 Jul;93(1):53-61. doi: 10.3171/jns.2000.93.1.0053.

  PMID: 10883905 BACKGROUND

• Kuo JR, Wang CC, Chio CC, Cheng TJ. Neurological improvement after cranioplasty - analysis by transcranial doppler ultrasonography. J Clin Neurosci. 2004 Jun;11(5):486-9. doi: 10.1016/j.jocn.2003.06.005.

  PMID: 15177389 BACKGROUND

• Yamaura A, Makino H. Neurological deficits in the presence of the sinking skin flap following decompressive craniectomy. Neurol Med Chir (Tokyo). 1977;17(1 Pt 1):43-53. doi: 10.2176/nmc.17pt1.43. No abstract available.

  PMID: 74031 BACKGROUND

• Hutchinson PJ, Kolias AG, Timofeev IS, Corteen EA, Czosnyka M, Timothy J, Anderson I, Bulters DO, Belli A, Eynon CA, Wadley J, Mendelow AD, Mitchell PM, Wilson MH, Critchley G, Sahuquillo J, Unterberg A, Servadei F, Teasdale GM, Pickard JD, Menon DK, Murray GD, Kirkpatrick PJ; RESCUEicp Trial Collaborators. Trial of Decompressive Craniectomy for Traumatic Intracranial Hypertension. N Engl J Med. 2016 Sep 22;375(12):1119-30. doi: 10.1056/NEJMoa1605215. Epub 2016 Sep 7.

  PMID: 27602507 BACKGROUND

Central Study Contacts

Kaya Xu

CONTACT

13984843194; xkaya@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study was open-label, endpoint-blinded, i.e. only the patients themselves and the treating physicians knew the randomization assignment results, baseline was evaluated by investigators who did not know the actual patient assignment, and primary endpoint visits were conducted by trained third parties who did not know what treatment the patients received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 11, 2025
• First Posted: September 19, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)