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Autograft vs Synthetic Allograft for Surgical Procedures

N/A

Waitlist Available

Led By William Ashley, MD, PhD, MBA

Research Sponsored by LifeBridge Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

All adult patients being considered for CP surgery by the investigating physician at the Life Bridge Health-Sinai Hospital of Baltimore

Patients who need cranial reconstruction

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year post-operation

Awards & highlights

Study Summary

This trial will compare two types of surgery for people with a certain medical condition. One type of surgery uses part of the patient's own bone, and the other type uses bone from a donor. The trial will look at how well each type of surgery works and what side effects each type has.

Who is the study for?

This trial is for English-speaking adults at Life Bridge Health-Sinai Hospital of Baltimore who require cranial reconstruction surgery. It's not for those with shattered skull fractures, skull tumors, or bone infections, nor can patients be chosen for a specific treatment group based on their clinical condition.Check my eligibility

What is being tested?

The study compares two methods of reconstructing the skull after emergency surgery to lower brain pressure: using the patient's own bone (autograft) or a synthetic material (allograft). The goal is to see which method leads to better overall outcomes.See study design

What are the potential side effects?

Since both autografts and synthetic allografts are standard care options approved by the FDA, they share similar risks associated with surgical procedures such as infection, bleeding, and reactions to anesthesia.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am an adult patient considered for CP surgery at Life Bridge Health-Sinai Hospital.

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I need surgery to repair or reconstruct my skull.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year post-operation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year post-operation

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year post-operation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

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

Secondary outcome measures

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

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

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

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Autograft groupActive Control1 Intervention

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

Group II: Allograft group (ClearFit)Active Control1 Intervention

The allograft group will receive a synthetic bone known as ClearFit

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

LifeBridge HealthLead Sponsor

28 Previous Clinical Trials

4,318 Total Patients Enrolled

William Ashley, MD, PhD, MBAPrincipal InvestigatorSinai Hospital of Baltimore

Media Library

Native Bone Autograft (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04855175 — N/A

Surgical Procedure Research Study Groups: Autograft group, Allograft group (ClearFit)

Surgical Procedure Clinical Trial 2023: Native Bone Autograft Highlights & Side Effects. Trial Name: NCT04855175 — N/A

Native Bone Autograft (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04855175 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any positions still available for participants in this research?

"The most recent update on clinicaltrials.gov reveals that this trial is still recruiting patients. This information is accurate as of 4/20/2021 and the study was originally posted on 2/10/2021."

Answered by AI

What goals does this clinical trial hope to achieve?

"This trial will seek to compare the surgical outcomes of two different standard care cohorts: autograft versus allograft (ClearFit). Assessments will be made over the course of a year post-operation. Additionally, patient satisfaction, disability, and pain levels will be monitored in order to generate secondary outcome data."

Answered by AI

If I wanted to, could I join this experiment?

"This trial has space for 50 individuals that are 18 years or older and have an upcoming surgical procedure. Additionally, those being considered for the study must meet the following two requirements: needing cranial reconstruction surgery as determined by a Life Bridge Health-Sinai Hospital of Baltimore physician and be willing to undergo CP surgery."

Answered by AI

How many people are signed up to be a part of this research project?

"That is accurate. The clinical trial in question, which is currently seeking participants, was originally posted on February 10th 2021 and most recently updated on April 20th 2021. 50 patients need to be enrolled from a single location."

Answered by AI