Surgical Procedure, UnspecifiedNCT04855175
Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft
A study testing Synthetic Bone Allograft (ClearFit) and Autograft in people with Surgical Procedure, Unspecified, run by LifeBridge Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- Synthetic Bone Allograft (ClearFit) and Autograft
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 14 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- Synthetic Bone Allograft (ClearFit), Autograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Synthetic Bone Allograft (ClearFit)Device
Patients in this arm will receive ClearFit (synthetic bone allograft)
AutograftOther
Patients in this arm will use patient's own bone
| Study group | Role | What they receive |
|---|---|---|
| Autograft group | Active comparator | The autologous group will receive bone harvested from the patient's own body Receives: Other: Autograft |
| Allograft group (ClearFit) | Active comparator | The allograft group will receive a synthetic bone known as ClearFit Receives: Device: Synthetic Bone Allograft (ClearFit) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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
Assess change in pain; ranking pain on a scale of 1 (least amount of pain)-10 (greatest amount of pain)
Measured: 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)
Assess change in disability; 6 item questionnaire; scores range from 0(minimal d disability)-60 (bed bound)
Measured: 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)
Assess change in quality of life; 36-item questionnaire, 0 (favorable health state life)-100 (poor health state)
Measured: 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
Patient Satisfaction questionnaire; 5 questions; scores range from 0(unsatisfied) - 22(completely satisfied)
Measured: at the 2 week visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2021
- Study start10 Feb 2021
- Primary completion14 Feb 2022
- Study completion14 Feb 2022
Why it stopped: Sponsor termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to one of two treatment groups.
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- LifeBridge Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Ashley, MD, PhD, MBA, Principal investigator, Sinai Hospital of Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04855175
- Sponsor's protocol ID
- 1682010
- Status last verified
- Jan 2025
- First submitted
- 9 Apr 2021
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Coelho F, Oliveira AM, Paiva WS, Freire FR, Calado VT, Amorim RL, Neville IS, de Andrade AF, Bor-Seng-Shu E, Anghinah R, Teixeira MJ. Comprehensive cognitive and cerebral hemodynamic evaluation after cranioplasty. Neuropsychiatr Dis Treat. 2014 May 2;10:695-701. doi: 10.2147/NDT.S52875. eCollection 2014.
PubMed 24833902Di Stefano C, Rinaldesi ML, Quinquinio C, Ridolfi C, Vallasciani M, Sturiale C, Piperno R. Neuropsychological changes and cranioplasty: A group analysis. Brain Inj. 2016;30(2):164-71. doi: 10.3109/02699052.2015.1090013. Epub 2015 Dec 8.
PubMed 26647093Honeybul S, Janzen C, Kruger K, Ho KM. The impact of cranioplasty on neurological function. Br J Neurosurg. 2013 Oct;27(5):636-41. doi: 10.3109/02688697.2013.817532. Epub 2013 Jul 25.
PubMed 23883370Shahid AH, Mohanty M, Singla N, Mittal BR, Gupta SK. The effect of cranioplasty following decompressive craniectomy on cerebral blood perfusion, neurological, and cognitive outcome. J Neurosurg. 2018 Jan;128(1):229-235. doi: 10.3171/2016.10.JNS16678. Epub 2017 Mar 3.
PubMed 28298042Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J. What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24.
PubMed 25534126Sundseth J, Sundseth A, Berg-Johnsen J, Sorteberg W, Lindegaard KF. Cranioplasty with autologous cryopreserved bone after decompressive craniectomy: complications and risk factors for developing surgical site infection. Acta Neurochir (Wien). 2014 Apr;156(4):805-11; discussion 811. doi: 10.1007/s00701-013-1992-6. Epub 2014 Feb 4.
PubMed 24493001Martin KD, Franz B, Kirsch M, Polanski W, von der Hagen M, Schackert G, Sobottka SB. Autologous bone flap cranioplasty following decompressive craniectomy is combined with a high complication rate in pediatric traumatic brain injury patients. Acta Neurochir (Wien). 2014 Apr;156(4):813-24. doi: 10.1007/s00701-014-2021-0. Epub 2014 Feb 16.
PubMed 24532225Klinger DR, Madden C, Beshay J, White J, Gambrell K, Rickert K. Autologous and acrylic cranioplasty: a review of 10 years and 258 cases. World Neurosurg. 2014 Sep-Oct;82(3-4):e525-30. doi: 10.1016/j.wneu.2013.08.005. Epub 2013 Sep 13.
PubMed 24036124Moreira-Gonzalez A, Jackson IT, Miyawaki T, Barakat K, DiNick V. Clinical outcome in cranioplasty: critical review in long-term follow-up. J Craniofac Surg. 2003 Mar;14(2):144-53. doi: 10.1097/00001665-200303000-00003.
PubMed 12621283Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133.
PubMed 19612971Walcott BP, Kwon CS, Sheth SA, Fehnel CR, Koffie RM, Asaad WF, Nahed BV, Coumans JV. Predictors of cranioplasty complications in stroke and trauma patients. J Neurosurg. 2013 Apr;118(4):757-62. doi: 10.3171/2013.1.JNS121626. Epub 2013 Feb 8.
PubMed 23394335Korhonen TK, Tetri S, Huttunen J, Lindgren A, Piitulainen JM, Serlo W, Vallittu PK, Posti JP. Predictors of primary autograft cranioplasty survival and resorption after craniectomy. J Neurosurg. 2018 May 11;130(5):1672-1679. doi: 10.3171/2017.12.JNS172013. Print 2019 May 1.
PubMed 29749908Malcolm JG, Mahmooth Z, Rindler RS, Allen JW, Grossberg JA, Pradilla G, Ahmad FU. Autologous Cranioplasty is Associated with Increased Reoperation Rate: A Systematic Review and Meta-Analysis. World Neurosurg. 2018 Aug;116:60-68. doi: 10.1016/j.wneu.2018.05.009. Epub 2018 May 16.
PubMed 29753896van de Vijfeijken SECM, Munker TJAG, Spijker R, Karssemakers LHE, Vandertop WP, Becking AG, Ubbink DT; CranioSafe Group. Autologous Bone Is Inferior to Alloplastic Cranioplasties: Safety of Autograft and Allograft Materials for Cranioplasties, a Systematic Review. World Neurosurg. 2018 Sep;117:443-452.e8. doi: 10.1016/j.wneu.2018.05.193. Epub 2018 Jun 5.
PubMed 29879511Schoekler B, Trummer M. Prediction parameters of bone flap resorption following cranioplasty with autologous bone. Clin Neurol Neurosurg. 2014 May;120:64-7. doi: 10.1016/j.clineuro.2014.02.014. Epub 2014 Feb 24.
PubMed 24731578
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cranioplasty Using Native Bone Autograft Versus Synthetic Bone Allograft
- ClinicalTrials.gov ID
- NCT04855175
- Acronym / sponsor ID
- 1682010
- Conditions
- Surgical Procedure, Unspecified
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor termination
- Enrolment
- 1 participants (actual)
- Lead sponsor
- LifeBridge HealthUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 14 Feb 2022 (actual)
- First posted
- 22 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to one of two treatment groups.
| Arm | Type | Receives |
|---|---|---|
| Autograft group | Active comparator | Other: AutograftThe autologous group will receive bone harvested from the patient's own body |
| Allograft group (ClearFit) | Active comparator | Device: Synthetic Bone Allograft (ClearFit)The allograft group will receive a synthetic bone known as ClearFit |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Synthetic Bone Allograft (ClearFit)Patients in this arm will receive ClearFit (synthetic bone allograft) | Device | Allograft group (ClearFit) |
| AutograftPatients in this arm will use patient's own bone | Other | Autograft group |
Primary outcome
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
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
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
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
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
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
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
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)
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
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)
4 secondary outcomes
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
To assess change in disability using the Oswestry Disability Index (ODI)
Time frame: 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
To assess overall patient satisfaction of two standard of care cohorts: autograft versus allograft (ClearFit)Patient Satisfaction
Time frame: at the 2 week visit
Results and safety
The study was stopped early (reason given: Sponsor termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2025.
- Background: PubMed 24833902Coelho F, Oliveira AM, Paiva WS, Freire FR, Calado VT, Amorim RL, Neville IS, de Andrade AF, Bor-Seng-Shu E, Anghinah R, Teixeira MJ. Comprehensive cognitive and cerebral hemodynamic evaluation after cranioplasty. Neuropsychiatr Dis Treat. 2014 May 2;10:695-701. doi: 10.2147/NDT.S52875. eCollection 2014.
- Background: PubMed 26647093Di Stefano C, Rinaldesi ML, Quinquinio C, Ridolfi C, Vallasciani M, Sturiale C, Piperno R. Neuropsychological changes and cranioplasty: A group analysis. Brain Inj. 2016;30(2):164-71. doi: 10.3109/02699052.2015.1090013. Epub 2015 Dec 8.
- Background: PubMed 23883370Honeybul S, Janzen C, Kruger K, Ho KM. The impact of cranioplasty on neurological function. Br J Neurosurg. 2013 Oct;27(5):636-41. doi: 10.3109/02688697.2013.817532. Epub 2013 Jul 25.
- Background: PubMed 28298042Shahid AH, Mohanty M, Singla N, Mittal BR, Gupta SK. The effect of cranioplasty following decompressive craniectomy on cerebral blood perfusion, neurological, and cognitive outcome. J Neurosurg. 2018 Jan;128(1):229-235. doi: 10.3171/2016.10.JNS16678. Epub 2017 Mar 3.
- Background: PubMed 25534126Stieglitz LH, Fung C, Murek M, Fichtner J, Raabe A, Beck J. What happens to the bone flap? Long-term outcome after reimplantation of cryoconserved bone flaps in a consecutive series of 92 patients. Acta Neurochir (Wien). 2015 Feb;157(2):275-80. doi: 10.1007/s00701-014-2310-7. Epub 2014 Dec 24.
- Background: PubMed 24493001Sundseth J, Sundseth A, Berg-Johnsen J, Sorteberg W, Lindegaard KF. Cranioplasty with autologous cryopreserved bone after decompressive craniectomy: complications and risk factors for developing surgical site infection. Acta Neurochir (Wien). 2014 Apr;156(4):805-11; discussion 811. doi: 10.1007/s00701-013-1992-6. Epub 2014 Feb 4.
- Background: PubMed 24532225Martin KD, Franz B, Kirsch M, Polanski W, von der Hagen M, Schackert G, Sobottka SB. Autologous bone flap cranioplasty following decompressive craniectomy is combined with a high complication rate in pediatric traumatic brain injury patients. Acta Neurochir (Wien). 2014 Apr;156(4):813-24. doi: 10.1007/s00701-014-2021-0. Epub 2014 Feb 16.
- Background: PubMed 24036124Klinger DR, Madden C, Beshay J, White J, Gambrell K, Rickert K. Autologous and acrylic cranioplasty: a review of 10 years and 258 cases. World Neurosurg. 2014 Sep-Oct;82(3-4):e525-30. doi: 10.1016/j.wneu.2013.08.005. Epub 2013 Sep 13.
- Background: PubMed 12621283Moreira-Gonzalez A, Jackson IT, Miyawaki T, Barakat K, DiNick V. Clinical outcome in cranioplasty: critical review in long-term follow-up. J Craniofac Surg. 2003 Mar;14(2):144-53. doi: 10.1097/00001665-200303000-00003.
- Background: PubMed 19612971Chang V, Hartzfeld P, Langlois M, Mahmood A, Seyfried D. Outcomes of cranial repair after craniectomy. J Neurosurg. 2010 May;112(5):1120-4. doi: 10.3171/2009.6.JNS09133.
- Background: PubMed 23394335Walcott BP, Kwon CS, Sheth SA, Fehnel CR, Koffie RM, Asaad WF, Nahed BV, Coumans JV. Predictors of cranioplasty complications in stroke and trauma patients. J Neurosurg. 2013 Apr;118(4):757-62. doi: 10.3171/2013.1.JNS121626. Epub 2013 Feb 8.
- Background: PubMed 29749908Korhonen TK, Tetri S, Huttunen J, Lindgren A, Piitulainen JM, Serlo W, Vallittu PK, Posti JP. Predictors of primary autograft cranioplasty survival and resorption after craniectomy. J Neurosurg. 2018 May 11;130(5):1672-1679. doi: 10.3171/2017.12.JNS172013. Print 2019 May 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William Ashley, MD, PhD, MBA principal investigator
Sinai Hospital of Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Synthetic Bone Allograft (ClearFit) and Autograft in people with Surgical Procedure, Unspecified, run by LifeBridge Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor termination). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the surgical and post-operative outcomes (complications) of two standard of care cohorts: autograft versus allograft (ClearFit) (time frame: intraoperatively). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04855175, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2025.