Skull DefectPEEKCPNCT05291754
3D Printed PEEK Implants for Cranioplasty
A study testing PEEK Cranioplasty in people with Skull Defect, run by Skane University Hospital at 1 site in Sweden.
Trial summary
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Defect
- What is being tested?
- PEEK Cranioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- 26 Nov 2021to 26 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Scheduled for cranioplasty
- Informed consent
Who cannot join
- No informed consent
- Implant size greater than 12x12 cm
Trial locations and contacts
1 site in 1 country.
About this study
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. The primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to compare complication rates with conventional methods such as autologous bone and polymethylmetacrylate (PMMA).
Read the detailed description
Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma, infection or decompressive craniectomy. Although some patients can tolerate cranial defects for varied periods of time, cranioplasty is mostly indicated due to the increased risk of additional brain trauma, local pain or impaired CSF circulation but also aesthetic and psychological issues. The gold standard for repair since many years is cranioplasty with autologous bones . However, sometimes it not feasible to use the patient's autologous bone due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the autologous bone grafts several different materials have been used, or are in use, as titanium meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous polyethylene. Some of these have gathered increased interest due to advancements in technology for manufacture of these materials, and also the possibility to create custom made implants or moulds.
The present study aims to assay safety and feasibility of in house 3D printed medical grade PEEK implants in research persons with acquired skull defects.
The implants will be manufactured after 3D rendering from CT images of the skull defects, sterilised and aseptically inserted in the defects by means of a surgical intervention.
A safety interim analysis will be performed after inclusion of 10 patients.
- Conditions
- Skull Defect
- Being tested
- PEEK Cranioplasty
- Keywords
- PEEK, Cranioplasty, 3D printer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEK CranioplastyDevice
3D printed PEEK skull implant
| Study group | Role | What they receive |
|---|---|---|
| Cranioplasty PEEK | Other | Not described Receives: Device: PEEK Cranioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performed PEEK implants
Percentage of performed PEEK implants out of included patients.
Measured: At end of surgical procedure, up to 2 months after inclusion
Safety of PEEK implants
Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants.
Measured: 1 year
Secondary outcomes (2)
Exposure time of PEEK implants compared to PMMA implants.
Compare exposure time for PEEK implant during surgery with historical PMMA implants made in 3D printed mold.
Measured: During surgical procedure, up to 2 months after inclusion.
Complications of PEEK implants
Complications after PEEK implants other than those leading to extraction of implant will be compared to historical PMMA and autologous bone implants.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start26 Nov 2021
- Primary completion26 Dec 2025
- Study completion26 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull DefectStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, non randomised and single arm
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Region Skane, Lund University
- Responsible party
- Principal investigator, Peter Siesjö, Skane University Hospital
- Investigators
- Einar Heiberg, MD, PhD, Study director, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05291754
- Sponsor's protocol ID
- Ver1.2
- Acronym
- PEEKCP
- Status last verified
- Oct 2025
- First submitted
- 26 Nov 2021
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Printed PEEK Implants for Cranioplasty
- ClinicalTrials.gov ID
- NCT05291754
- Acronym / sponsor ID
- PEEKCP / Ver1.2
- Conditions
- Skull Defect
- Keywords
- PEEK, Cranioplasty, 3D printer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Collaborators
- Region Skane, Lund University
- Study start
- 26 Nov 2021 (actual)
- Primary completion
- 26 Dec 2025 (actual)
- Study completion
- 26 Mar 2026 (estimated)
- First posted
- 23 Mar 2022 (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.
This study is a non-randomised and single center study with patients needing an artificial skull bone eg cranioplasty. 40 patients will be implanted with in house manufactured polyether ether ketone (PEEK) implants using a fused filament fabrication 3D printer. The primary aim is to ascertain safety and feasibility of the procedure. The secondary aim is to compare complication rates with conventional methods such as autologous bone and polymethylmetacrylate (PMMA).
Detailed description
Cranioplasty is the surgical repair of a congenital or cranial defects after head trauma, infection or decompressive craniectomy. Although some patients can tolerate cranial defects for varied periods of time, cranioplasty is mostly indicated due to the increased risk of additional brain trauma, local pain or impaired CSF circulation but also aesthetic and psychological issues. The gold standard for repair since many years is cranioplasty with autologous bones . However, sometimes it not feasible to use the patient's autologous bone due to infections, trauma, bone graft resorption and donor-site morbidity. To replace the autologous bone grafts several different materials have been used, or are in use, as titanium meshes, hydroxyapatite cement and plastic resins as polymethyl methacrylate (PMMA) and porous polyethylene. Some of these have gathered increased interest due to advancements in technology for manufacture of these materials, and also the possibility to create custom made implants or moulds.
The present study aims to assay safety and feasibility of in house 3D printed medical grade PEEK implants in research persons with acquired skull defects.
The implants will be manufactured after 3D rendering from CT images of the skull defects, sterilised and aseptically inserted in the defects by means of a surgical intervention.
A safety interim analysis will be performed after inclusion of 10 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, non randomised and single arm
| Arm | Type | Receives |
|---|---|---|
| Cranioplasty PEEK | Other | Device: PEEK Cranioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for cranioplasty
- Informed consent
Key exclusion criteria (2 listed)
- No informed consent
- Implant size greater than 12x12 cm
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 |
|---|---|---|
| PEEK Cranioplasty3D printed PEEK skull implant | Device | Cranioplasty PEEK |
Primary outcome
Performed PEEK implants
Time frame: At end of surgical procedure, up to 2 months after inclusion
Percentage of performed PEEK implants out of included patients.
Safety of PEEK implants
Time frame: 1 year
Survival percentage of PEEK implants. Will be compared to historical PMMA and autologous bone implants.
2 secondary outcomes
Exposure time of PEEK implants compared to PMMA implants.
Time frame: During surgical procedure, up to 2 months after inclusion.
Complications of PEEK implants
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
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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.
Einar Heiberg, MD, PhD study director
Skane University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEK Cranioplasty in people with Skull Defect, run by Skane University Hospital at 1 site 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 21 Jan 2026. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Performed PEEK implants (time frame: At end of surgical procedure, up to 2 months after inclusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2026.