E04.525.190NCT01282645
Case Series to Evaluate Patient Specific Implants (PSI) in Polyether Ether Ketone (PEEK) Performance After 2 Years
An observational study of E04.525.190 and Craniotomy, run by Synthes GmbH at 30 sites in 15 countries.
Trial summary
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- E04.525.190, Craniotomy, Craniectomy
- What is being tested?
- PSI in PEEK
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- 30 sitesin 15 countries
- Study dates
- Jul 2011to Jan 2012
- Phase
- Observational
- 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
Study population: In 30 clinics worldwide, all patients who received a PSI in PEEK at least 2 years ago, who fullfil the in-and exclusion criteria, will be asked to participate
Who may be able to join
- Males or females age 18 years or over at the time of inclusion into the study
- Received a Synthes PSI® made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
- Ability to obtain written informed consent from the recipient or the recipient's legal guardian
- Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
Who cannot join
- Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
Trial locations and contacts
30 sites in 15 countries.
30 sites in 15 countries
Germany5 sites
Universitätsklinikum Aachen
Aachen
HELIOS-Klinikum Emil von Behring
Berlin
Universitätsklinikum Düsseldorf
Düsseldorf
Clemenshospital Münster
Heidelberg
Universitätsklinikum Heidelberg
Heidelberg
Switzerland5 sites
Inselspital
Bern
Hôpital Cantonal Universitaire
Geneva
Centre Hospitalier Universitaire Vaudois
Lausanne
Kantonsspital St- Gallen
Sankt Gallen
Universitätsspital Zürich
Zurich
Colombia4 sites
Hospital San José
Bogotá
Hospital Universitario San Ignacio
Bogotá
Instituto Roosevelt
Bogotá
Hospital Universitario del Valle
Santiago de Cali
Spain3 sites
Hospital 12 de Octubre
Madrid
Ramon y Cajal Hospital
Madrid
Clinica Universitaria Navarra
Pamplona
Chile2 sites
Hospital San Pablo de Coquimbo
Coquimbo
Hospital de Trabajador de Santiago
Santiago
United Kingdom2 sites
Queen Victoria Hospital
East Grinstead
The Walton Center
Liverpool
About this study
Official title: A Retrospective Case Series to Evaluate the Long Term Outcome of the Use of Synthes Patient Specific Implants (PSI®) Made of Polyether Ether Ketone (PEEK) for the Treatment of Cranial Defects in Patients With a Mature Skeleton
The primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Being tested
- PSI in PEEK
- Keywords
- Cranial defect, PSI, patient specific implant, PEEK, polyether ether ketone, craniectomy, craniotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSI in PEEKDevice
Also called Patient Specific Implant in Polyether Ether Ketone
A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect
| Study group | Role | What they receive |
|---|---|---|
| PSI in PEEK | All study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect Receives: Device: PSI in PEEK |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device related adverse events
Percentage of patients with the following device related adverse events:
- infection
- rejection
- dislocation
- fracture
Measured: 0-24 months post initial implantation
Secondary outcomes (9)
Explantation
Explantation, as a result of a device-related adverse event or for another reason
Measured: 0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)
Cosmetic result
Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, immediately after the surgery or until the patient was discharged from the hospital (any timepoint available)
Measured: surgery - at discharge
Cosmetic result
Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)
Measured: at the study visit, which is at least 24 months after implantation
Clinical result
Evaluation of the clinical result by the surgeon by means of a VAS 0-100, immediately after the surgery or until the patient was discharged from the hospital (any timepoint available)
Measured: surgery - at discharge
Clinical result
Evaluation of the cosmetic result by the surgeon by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)
Measured: At the study visit, which is at least 24 months after implantation
Pressure sensitivity
Evaluation of the pressure sensitivity by the patient (or next of kin appreciation in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)
Measured: At the study visit, which is at least 24 months after implantation
Heat / cold sensitivity
Evaluation of the heat/cold sensitivity by the patient (or next of kin appreciation in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)
Measured: At the study visit, which is at least 24 months after implantation
Cosmetic result
Evaluation of the cosmetic result by the patient (or next of kin in case of severe disability) by means of a VAS 0-100, during the study visit, at least 24 months after implantation (see inclusion criteria)
Measured: At the study visit, which is at least 24 months after implantation
Event-free survival
Number of months of event-free survival, in terms of device related adverse events:
- Infection (superficial and/or deep) [Time frame 0 months - study visit]
- Rejection of the implant [Time frame 0 months - study visit]
- Dislocation of the implant [Time frame 0 months - study visit]
- Fracture of the implant [Time frame 0 months - study visit]
Measured: 0 months - at the study visit, which is at least 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJul 2011
- Primary completionJan 2012 (estimated)
- Study completionJan 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for E04.525.190Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synthes GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Frédéric Lauwers, MD, Principal investigator, Centre Hospitalier Universitaire de Toulouse, Toulouse, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282645
- Sponsor's protocol ID
- STU-CMF-C-16-204-01
- Status last verified
- Mar 2013
- First submitted
- 24 Jan 2011
- Last updated
- 22 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Case Series to Evaluate the Long Term Outcome of the Use of Synthes Patient Specific Implants (PSI®) Made of Polyether Ether Ketone (PEEK) for the Treatment of Cranial Defects in Patients With a Mature Skeleton
- ClinicalTrials.gov ID
- NCT01282645
- Acronym / sponsor ID
- STU-CMF-C-16-204-01
- Conditions
- E04.525.190, Craniotomy, Craniectomy
- Keywords
- Cranial defect, PSI, patient specific implant, PEEK, polyether ether ketone, craniectomy, craniotomy
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Synthes GmbHIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Jan 2012 (estimated)
- Study completion
- Jan 2012 (estimated)
- First posted
- 25 Jan 2011 (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 primary objective of this retrospective study is to evaluate the percentage of patients with device related adverse events (infection, rejection, dislocation, fracture of the implant) in the first 24 months after implantation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PSI in PEEK | – | Device: PSI in PEEKAll study subjects have received a Patient Specific Implant (PSI) made of PEEK to repair a cranial defect |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In 30 clinics worldwide, all patients who received a PSI in PEEK at least 2 years ago, who fullfil the in-and exclusion criteria, will be asked to participate
Key inclusion criteria (4 listed)
- Males or females age 18 years or over at the time of inclusion into the study
- Received a Synthes PSI® made of PEEK intended for replacement of bony voids in the cranial/craniofacial skeleton at least 24 months before inclusion in the study
- Ability to obtain written informed consent from the recipient or the recipient's legal guardian
- Ability to comply with the procedures described in the protocol, including responding to simple questionnaires either by the recipient in person or by a next relative (spouse, parent) who lives with the recipient
Key exclusion criteria (1 listed)
- Patient was contraindicated to receive a PSI made of PEEK at the time of implantation
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 |
|---|---|---|
| PSI in PEEKAlso: Patient Specific Implant in Polyether Ether KetoneA Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect | Device | PSI in PEEK |
Primary outcome
Device related adverse events
Time frame: 0-24 months post initial implantation
Percentage of patients with the following device related adverse events: * infection * rejection * dislocation * fracture
9 secondary outcomes
Explantation
Time frame: 0 months - study visit at least 24 months after implantation (or scheduled up to 3 months after the study visit)
Cosmetic result
Time frame: surgery - at discharge
Cosmetic result
Time frame: at the study visit, which is at least 24 months after implantation
Clinical result
Time frame: surgery - at discharge
Clinical result
Time frame: At the study visit, which is at least 24 months after implantation
Pressure sensitivity
Time frame: At the study visit, which is at least 24 months after implantation
Heat / cold sensitivity
Time frame: At the study visit, which is at least 24 months after implantation
Cosmetic result
Time frame: At the study visit, which is at least 24 months after implantation
Event-free survival
Time frame: 0 months - at the study visit, which is at least 24 months after implantation
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2013.
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.
Frédéric Lauwers, MD principal investigator
Centre Hospitalier Universitaire de Toulouse, Toulouse, France
30 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of E04.525.190 and Craniotomy, run by Synthes GmbH at 30 sites in 15 countries.
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 1 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: withdrawn, as of the sponsor's last update on 22 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in Germany, Switzerland, Colombia, Spain, Chile and 10 more countries. 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 withdrawn before enrolling participants, so there are no results.
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?
Device related adverse events (time frame: 0-24 months post initial implantation). 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 22 Mar 2013.