Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

NCT04855175 | Terminated FDA Device

• 1 other identifier: 1682010
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Elevated intracranial pressure (ICP) is a common neurosurgical emergency that may arise from several conditions, which cause an intracranial mass effect. In the case of conservatively refractory ICP elevation, one viable treatment option is ICP-lowering surgery, i.e., decompressive craniectomy (DC) in which a large portion of the skull bone is removed and the dura mater opened, creating more room for the brain tissue to expand and thus reducing the ICP. A successful CP will restore the contour of the cranium, protect the brain, and ensure a natural ICP, and some patients also show neurological improvement post-CP. Thus, CP has a great potential for improving the patient's quality of life. Bone flap resorption (BFR) implies weakening and loosening of the autologous bone flap after reimplantation and is regarded as a late CP complication involving nonunion of the bone flap with the surrounding bone margins and cavity formation in the flap itself, which eventually necessitates removal of the bone flap and a new CP using a synthetic implant. These additional operations increase costs and necessitate further hospital stays, while rendering the patient vulnerable to additional complications. Prior research performed as part of the FDA approval process has shown the ASPCI's to be a safe and effective means of performing cranial reconstruction, the anticipated risks do not differ from the risks faced by a patient undergoing either option as they are both currently considered standards of care. This study will evaluate the overall patient outcomes of cranial reconstruction surgery using native bone autograft as compared to using synthetic bone allograft.

Conditions

Surgical Procedure, Unspecified

Outcome Measures

Primary Outcomes (10)

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  intraoperatively

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  post-operatively through study completion, an average of 1 year

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  2 weeks post-operation

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  6 weeks post-operation

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  3 months post-operation

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  6 months post-operation

• To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Asses for infection, hematomas, fractures, mobilization and scar retraction, wound site infection, UTI, pneumonia, delayed internal bleeding, reoperation, and hardware failure

  1 year post-operation

• To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Barthel index consisting of 10 questions - score range 0 (completely dependent)- 20 (completely independent)

  24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year

• To assess change in surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Karnofsky scale (0-100); 0 indicating death and 100 indicating no additional help is needed

  24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year

• To assess change the surgical and post-operative outcomes (function) of two standard of care cohorts: autograft versus allograft (ClearFit)

  Glasgow Outcome Scale (GOS) on a scale of 1(death)- 5 (good recovery)

  24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year

Secondary Outcomes (4)

• To assess change in pain using the Visual Analogue Scale (VAS) Pain scale

  24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year

• To assess change in disability using the Oswestry Disability Index (ODI)

  2 weeks, 6 weeks, 3 months, 6 months, and 1 year

• To assess change in quality of life using the Health and Quality of life improvement (SF-36)

  2 weeks, 6 weeks, 3 months, 6 months, and 1 year

• To assess overall patient satisfaction of two standard of care cohorts: autograft versus allograft (ClearFit)Patient Satisfaction

  at the 2 week visit

Study Arms (2)

Autograft group

ACTIVE COMPARATOR

The autologous group will receive bone harvested from the patient's own body

Other: Autograft

Allograft group (ClearFit)

ACTIVE COMPARATOR

The allograft group will receive a synthetic bone known as ClearFit

Device: Synthetic Bone Allograft (ClearFit)

Interventions

Synthetic Bone Allograft (ClearFit) DEVICE

Patients in this arm will receive ClearFit (synthetic bone allograft)

Allograft group (ClearFit)

Autograft OTHER

Patients in this arm will use patient's own bone

Autograft group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients being considered for CP surgery by the investigating physician at the Life Bridge Health-Sinai Hospital of Baltimore
• Able to read and speak English, or have LAR who reads and speaks English
• Patients who need cranial reconstruction

You may not qualify if:

• Patients affected by comminuted skull fractures,
• Patients affected by osteomyelitis,
• Patients with skull neoplasm and therefore not be candidates for autologous CP
• Patients who would need to be allocated to one group over the other due to clinical presentation

Sponsors & Collaborators

• LifeBridge Health: lead

Study Sites (1)

Sinai Hospital of Baltimore

Baltimore, Maryland, 21215, United States

Location

Related Publications (24)

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MeSH Terms

Interventions

Transplantation, Autologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• William Ashley, MD, PhD, MBA

  Sinai Hospital of Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two treatment groups.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 22, 2021
• Study Start: February 10, 2021
• Primary Completion: February 14, 2022
• Study Completion: February 14, 2022
• Last Updated: January 22, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)