Defect of Skull OssificationNCT01899807

Bone Reconstruction of the Skull Using a Metal Ceramic Implant After Previously Failed Reconstruction

A study testing OssDsign AB in people with Defect of Skull Ossification and Other Specified Skull or Face Bone Anomaly, run by Karolinska University Hospital at 2 sites in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

The purpose of this study is to evaluate a new ceramic metal bone graft substitute for hemi craniectomies. The frequency of infections and rupture of skin will be studied, which is a reoccurring problem with currently used bone graft substitutes in this subject population. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Defect of Skull Ossification, Other Specified Skull or Face Bone Anomaly, Cranial Dysostosis Nec
What is being tested?: OssDsign AB
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 2 sitesSweden
Study dates: Jun 2013to Mar 2016
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Obtained informed consent.
Males or females, ≥18 years of age
Subject with cranial defect size > 25 cm2.
History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
Willing and able to comply with all study procedures and restrictions.
The 5 subjects participating in bone regeneration analysis (PET/CT scans) has to be 50 years or older

Who cannot join

Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
Pregnant or nursing women.
Perioperative appearance of previously not identified tumor or infection in the reconstruction area.

Trial locations and contacts

2 sites in 1 country.

Sweden2 sites

Dept. of Neurosurgery, Sahlgrenska University Hospital
Gothenburg, 413 45
Dept. of Neurosurgery, Karolinska Universitetssjukhuset
Stockholm

Other trials in Sweden

About this study

Official title: Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series

Conditions: Defect of Skull Ossification, Other Specified Skull or Face Bone Anomaly, Cranial Dysostosis Nec, Hemicraniectomy
Being tested: OssDsign AB

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OssDsign ABDevice

Study groups in NCT01899807
Study group	Role	What they receive
Single Arm	Other	Not described Receives: Device: OssDsign AB

What is being measured

The primary outcome is the main question the study is designed to answer.

Rate of adverse events
The primary endpoint, rate of adverse events, will be measured by clinical evidence of infection and/or manifested rupture of skin around the implant, within 12 months, that necessitates explantation.
Measured: From the date of intervention up to 12 months post intervention

Secondary outcomes (4)

Percentage subjects with an adverse event
Measured: From the date of intervention up to 14 days, 3 months, 6 months follow-up
Quality of life scores
SF-12 and EQ5D 3L will be used
Measured: Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area
The bone tracer (18 F fluoride) will be used to measure bone regeneration.
Measured: The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
Subject mean MOCA
Subject cognitive impairment is measured by Montreal Cognitive Assessment (MOCA) (the subject will be given a score after completing the assessment)
Measured: 3 months and 12 months follow-up compared to baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2013Mar 2016

First posted15 Jul 2013 (estimated)
Study startJun 2013
Primary completionMar 2016 (estimated)
Study completionMar 2016 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Defect of Skull OssificationStudies of the same condition, open and under way.
More trials run by Karolinska University HospitalThe sponsor's other registered studies.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01899807
Sponsor's protocol ID: OQ-CR-001
Status last verified: Mar 2015
First submitted: 2 Jul 2013
Last updated: 31 Mar 2015
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cranial Reconstruction With Patient-specific Titanium Mesh/Mosaic-designed Calcium Phosphate-implant - A Multi Center Center, Single Arm, Non-comparative Prospective Case Series
ClinicalTrials.gov ID: NCT01899807
Acronym / sponsor ID: OQ-CR-001
Conditions: Defect of Skull Ossification, Other Specified Skull or Face Bone Anomaly, Cranial Dysostosis Nec, Hemicraniectomy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 11 participants (actual)
Lead sponsor: Karolinska University HospitalUniversity, hospital or other
Study start: Jun 2013
Primary completion: Mar 2016 (estimated)
Study completion: Mar 2016 (estimated)
First posted: 15 Jul 2013 (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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Single Arm	Other	Device: OssDsign AB

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Obtained informed consent.
Males or females, ≥18 years of age
Subject with cranial defect size > 25 cm2.
History of previous cranial implant failure and where the latest cranial reconstruction failed within 12 months. (This means that the patient demonstrates a non-reconstructed cranial defect after removal of implant or exhibit an implant failure, e.g. local infection and/or protrusion through the skin.)
Willing and able to comply with all study procedures and restrictions.

Key exclusion criteria (3 listed)

Malignancy adjacent to the reconstruction area, including brain and calvaria, with on-going or planned surgical intervention.
Pregnant or nursing women.
Perioperative appearance of previously not identified tumor or infection in the reconstruction area.

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
OssDsign AB	Device	Single Arm

Primary outcome

Rate of adverse events
Time frame: From the date of intervention up to 12 months post intervention
The primary endpoint, rate of adverse events, will be measured by clinical evidence of infection and/or manifested rupture of skin around the implant, within 12 months, that necessitates explantation.

4 secondary outcomes

Percentage subjects with an adverse event
Time frame: From the date of intervention up to 14 days, 3 months, 6 months follow-up
Quality of life scores
Time frame: Assessed during the 3 month- and 12 month follow-up visit post intervention, compared to the screening visit: 3-0 weeks prior to intervention
PET/CT analysis with bone tracer, confirms bone regeneration activity within the reconstruction area
Time frame: The PET/CT scan will be taken at 12 months post intervention and it will be compared with 2 weeks post intervention
Subject mean MOCA
Time frame: 3 months and 12 months follow-up compared to baseline

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2015.

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.

Lars Kihlström, MD, MBA principal investigator

Department of Neurosurgery, Karolinska University Hospital

Kalle Lundgren, MD, PhD principal investigator

Karolinska University Hospital

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing OssDsign AB in people with Defect of Skull Ossification and Other Specified Skull or Face Bone Anomaly, run by Karolinska University Hospital at 2 sites in Sweden.

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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 31 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Sweden. 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?

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?

Rate of adverse events (time frame: From the date of intervention up to 12 months post intervention). 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 NCT01899807.

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 31 Mar 2015.