Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft

April 20, 2021 updated by: LifeBridge Health

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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. In many centers, the bone flap removed in DC is customarily kept deep frozen at -70°C until reimplantation during cranioplasty (CP). The cranium is repaired during CP by returning the previously removed autologous bone flap or by placing an artificial implant in the defect area. 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-CP1-4. Thus, CP has a great potential for improving the patient's quality of life. Although widely regarded as a routine operation, CP often involves serious complications, such as postoperative hemorrhages, surgical site infection (SSI), and, most importantly, resorption of the autologous bone flap5-8.

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. The reported prevalence of BFR with autologous CPs has varied significantly, from 1.4% to 32.0%, with infection rates ranging from 4.6% to 16.4%9-12.

CP is a common procedure for cranial reconstruction in the setting of trauma, stroke, skull neoplasm, osteomyelitis, or after procedures that are approached via craniectomy such as microvascular decompression or acoustic neuroma.

Recently there have been two major areas of interest presenting in the literature. First, there have been at least 6 manuscripts published on retrospective data comparing autologous bone versus synthetic prosthetic for CP13-18. Each has shown benefit for synthetic prosthetics. However, the community is resistant to implement a treatment pattern where synthetic bone is a "first line" choice for CP. Therefore, a prospective randomized controlled trial is needed to understand with high confidence the option that is most beneficial for patients.

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.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Recruiting
        • Sinai Hospital of Baltimore
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Autograft group
The autologous group will receive bone harvested from the patient's own body
Other: Autograft
Patients in this arm will use patient's own bone
Active Comparator: Allograft group (ClearFit)
The allograft group will receive a synthetic bone known as ClearFit
Device: Synthetic Bone Allograft (ClearFit)
Patients in this arm will receive ClearFit (synthetic bone allograft)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit)
Time Frame: intraoperatively
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)
Time Frame: post-operatively through study completion, an average of 1 year
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)
Time Frame: 2 weeks post-operation
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)
Time Frame: 6 weeks post-operation
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)
Time Frame: 3 months post-operation
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)
Time Frame: 6 months post-operation
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)
Time Frame: 1 year post-operation
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)
Time Frame: 24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
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)
Time Frame: 24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
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)
Time Frame: 24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, 1-year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess change in pain using the Visual Analogue Scale (VAS) Pain scale
Time Frame: 24 hours post operation, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Assess change in pain; ranking pain on a scale of 1 (least amount of pain)-10 (greatest amount of pain)
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)
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Assess change in disability; 6 item questionnaire; scores range from 0(minimal d disability)-60 (bed bound)
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)
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, and 1 year
Assess change in quality of life; 36-item questionnaire, 0 (favorable health state life)-100 (poor health state)
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
Time Frame: at the 2 week visit
Patient Satisfaction questionnaire; 5 questions; scores range from 0(unsatisfied) - 22(completely satisfied)
at the 2 week visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBridge Health

Investigators

  • Principal Investigator: William Ashley, MD, PhD, MBA, Sinai Hospital of Baltimore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 10, 2021

Primary Completion (Anticipated)

February 10, 2024

Study Completion (Anticipated)

February 10, 2024

Study Registration Dates

First Submitted

April 9, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2021

Last Update Submitted That Met QC Criteria

April 20, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • IRB#1682010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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