Skull DefectsPhase 3NCT00923793
Comparison of Individual Computer Aided Design/Manufactured (CAD/CAM) - Based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty
A Phase 3 study testing Titanium implant (CranioConstruct™) and Hydroxylapatite (CustomBone) in people with Skull Defects and Cranioplasty, run by University of Leipzig at 1 site in Germany.
Trial summary
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Defects, Cranioplasty
- What is being tested?
- Titanium implant (CranioConstruct™) and Hydroxylapatite (CustomBone)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Apr 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skull defects without the possibility to be covered with the missing own bone
- Size of the defect ≥ 16 cm2
- Age ≥ 18
- Written informed consent of the patient
Who cannot join
- Active tumor
- ASA 4 classification
- Allergic disposition to ceramic or titanium
- Concomitant participation in other clinical trials
- Pregnant or nursing women
- Expected low compliance
- HIV positive
- Active drug abuses
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universität Leipzig KöR Medizinische Fakultät Klinik für Neurochirurgie
Leipzig, Saxony, 04107
About this study
Official title: Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.
Read the detailed description
Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.
- Conditions
- Skull Defects, Cranioplasty
- Being tested
- Titanium implant (CranioConstruct™), Hydroxylapatite (CustomBone)
- Keywords
- skull defects, Hydroxylapatite implant, Titanium implant, calotte defects without the possibility to be covered with the missing own bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Titanium implant (CranioConstruct™)Device
Also called CranioConstruct™
One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered.
Hydroxylapatite (CustomBone)Device
Also called CustomBone
Six to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered.
| Study group | Role | What they receive |
|---|---|---|
| Titanium | Active comparator | Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit. Receives: Device: Titanium implant (CranioConstruct™) |
| Hydroxylapatite | Experimental | Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed. Receives: Device: Hydroxylapatite (CustomBone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
Measured: 6 months
Secondary outcomes (6)
Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.
Measured: 6 months
Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms.
Measured: 48 hours post-operative
Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.
Measured: 6 months
Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.
Measured: 6 months
Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.
Measured: 6 months
Description of osteointegration with CT and bone scan six months post-operative in both groups
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Recruitment was stopped, due to slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Skull DefectsStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Universitätsklinikum Leipzig
- Responsible party
- Principal investigator, Dirk Lindner, University of Leipzig
- Investigators
- Dirk Lindner, Dr. med., Study director, Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00923793
- Sponsor's protocol ID
- CustomBone vs. Titanium
- Status last verified
- May 2015
- First submitted
- 17 Jun 2009
- Last updated
- 21 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Eufinger H, Weihe S, Scherer P, Rasche C, Wehmöller M. Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000. Int. J. CARS 2006; 1: 197-203
Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Muns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg. 2017 Jan;126(1):175-183. doi: 10.3171/2015.10.JNS151245. Epub 2016 Feb 26.
PubMed 26918471
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Individual CAD/CAM-based Implants Consisting on Hydroxylapatite and Titanium to be Used in Cranioplasty - a Randomized Multicenter Clinical Trial
- ClinicalTrials.gov ID
- NCT00923793
- Acronym / sponsor ID
- CustomBone vs. Titanium
- Conditions
- Skull Defects, Cranioplasty
- Keywords
- skull defects, Hydroxylapatite implant, Titanium implant, calotte defects without the possibility to be covered with the missing own bone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment was stopped, due to slow recruitment rate
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Universitätsklinikum Leipzig
- Study start
- Jun 2009
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 18 Jun 2009 (estimated)
- 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.
The purpose of this study is to compare the results of cranioplasty with CAD/CAM (computer aided design/manufactured) based Hydroxylapatite and Titanium implants in respect to infections, re-operations, antibiotic treatment or removal of the implant.
Detailed description
Both implant materials for cranioplasty, Hydroxylapatite and Titanium, are CE certified medical devices used in common practices. This study is intended to get prospective data in addition to the empirical and retrospective existing ones to enable the decision on which implant material should be preferably employed in future.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Titanium | Active comparator | Device: Titanium implant (CranioConstruct™)Titanium implant for cranioplasty. Titanium implants are used since 10 years in Germany because of their high biocompatibility and accuracy of fit. |
| Hydroxylapatite | Experimental | Device: Hydroxylapatite (CustomBone)Hydroxylapatite (CustomBone) implant Hydroxylapatite implants are used since about 3 years in Germany. As this material is very similar to human bone structure an improved osteointegration has been observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Skull defects without the possibility to be covered with the missing own bone
- Size of the defect ≥ 16 cm2
- Age ≥ 18
- Written informed consent of the patient
Key exclusion criteria (8 listed)
- Active tumor
- ASA 4 classification
- Allergic disposition to ceramic or titanium
- Concomitant participation in other clinical trials
- Pregnant or nursing women
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 |
|---|---|---|
| Titanium implant (CranioConstruct™)Also: CranioConstruct™One to three weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Titanium implant is ordered. | Device | Titanium |
| Hydroxylapatite (CustomBone)Also: CustomBoneSix to eight weeks before operation the skull defect is well defined using Computer tomography. Based on these results the Hydroxylapatite implant is ordered. | Device | Hydroxylapatite |
Primary outcome
Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation.
Time frame: 6 months
6 secondary outcomes
Comparison of the rate of re-operations with and without ex-plantation of the implant in both arms.
Time frame: 6 months
Comparison of post-operative computer tomography (CT) (native and bone 5 mm) within 48 h in respect to bleeding, dislocation and further complications after cranioplasty in both arms.
Time frame: 48 hours post-operative
Comparison of health-related quality of life after cranioplasty in both arms using the SF36-questionnaire.
Time frame: 6 months
Comparison between both groups referring to cosmetic result, period of hospitalization, costs, intra-operative features.
Time frame: 6 months
Comparison of temperature sensitivity (cold/heat) six months after implantation in both groups.
Time frame: 6 months
Description of osteointegration with CT and bone scan six months post-operative in both groups
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Recruitment was stopped, due to slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- BackgroundEufinger H, Weihe S, Scherer P, Rasche C, Wehmöller M. Management of cranial and craniofacial bone defects with prefabricated individual titanium implants: follow-up and evaluation of 166 patients with 169 titanium implants from 1994 to 2000. Int. J. CARS 2006; 1: 197-203
- Derived from this study: PubMed 26918471Lindner D, Schlothofer-Schumann K, Kern BC, Marx O, Muns A, Meixensberger J. Cranioplasty using custom-made hydroxyapatite versus titanium: a randomized clinical trial. J Neurosurg. 2017 Jan;126(1):175-183. doi: 10.3171/2015.10.JNS151245. Epub 2016 Feb 26.
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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.
Dirk Lindner, Dr. med. study director
Universität Leipzig KöR Medizinische Falkutät Klinif für Neurochirurgie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Titanium implant (CranioConstruct™) and Hydroxylapatite (CustomBone) in people with Skull Defects and Cranioplasty, run by University of Leipzig at 1 site in Germany.
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 4 inclusion and 8 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 21 May 2015. 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 Germany. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Recruitment was stopped, due to slow recruitment rate). 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?
Comparison of the rate of local and/or systemic infections (acute/chronic) in both study arms within the first 6 months after operation. (time frame: 6 months). 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 NCT00923793, which also lists 2 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 21 May 2015.