Neck stabilization using the PERLA® Occipital fixation system
| ISRCTN | ISRCTN82579275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82579275 |
| Secondary identifying numbers | P69_CLD002 |
- Submission date
- 23/11/2022
- Registration date
- 15/12/2022
- Last edited
- 11/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
This is a post-market study to confirm the performance and safety of the PERLA Occipital-Cervical-Thoracic system in the treatment of head-neck instability due that can be due to trauma, autoimmune disease, oncologic (cancer) or congenital (present from birth) reasons.
This treatment results in severe restriction of head movement after surgery. Therefore, this method should be restricted to patients with head-neck instability as a last resort.
The medical devices to stabilise the head-neck junction are composed of occipital plates, rods, and a screw system such as the PERLA Occipital-Cervical-Thoracic system.
Head-neck fixation is the treatment of choice in most cases of traumatic occipito-cervical dislocation. It is recommended in the most recent guidelines from the American Association of Neurological Surgeons (AANS)/Congress of Neurological Surgeons (CNS) Joint Guidelines Committee.
Who can participate?
Patients who received the PERLA Occipital plate at the participating centers
What does the study involve?
The site will review the medical charts of patients who received the investigated device. Those patients who are eligible for the study will be contacted to invite them to participate in the study. After reading the information letter, the patients should let their surgeon know if they agree/consent before any data collection. Clinical and x-ray data will be collected for preoperative, surgical, and postoperative clinical visits performed as the site standard of care.
What are the possible benefit and risks of participating?
As a retrospective study of real-world evidence data collection, there are no direct benefits or risks.
Where is the study run from?
Three hospitals or clinic in France, Germany and Austria
When is the study starting and how long is it expected to run for?
June 2022 to July 2024
Who is funding the study?
Spineart (Switzerland)
Who is the main contact?
clinic@spineart.com
Contact information
Scientific
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland
| Phone | +33 (0)225701200 |
|---|---|
| dbermingham@spineart.com |
Study information
| Study design | Real-world evidence retrospective multicentric international single-arm post-market clinical follow-up study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Retrospective study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format. Please use contact details to request a participant information sheet. |
| Scientific title | Occipitocervical spine stabilization using PERLA® posterior occipito-cervico-thoracic fixation. A post-market clinical follow-up study |
| Study acronym | PERLA Occipital plate |
| Study objectives | N/A. Non-probability sample size, due to the very low number of patients treated. The study is to confirm the performance and safety of the Perla Occipital plate for the treatment of instabilities in the craniocervical junction by collecting real-world evidence. |
| Ethics approval(s) | 1. France: Since it’s a fully retrospective study, only a registration on the Health Data Hub platform is needed; no contact details, website: https://www.health-data-hub.fr/projets; submission date 26/10/2022, ref: F20221026145427 2. Germany: Approved 20/03/2023, Ethik-Kommission der Bayerischen Landesärztekammer (EK der BLÄK, Mühlbaurstraße 16, 81677 München, Germany; +49 (0)89 4147 283; ethikkommission@blaek.de), ref: 22126 3. Austria: Approved 15/03/2024, Medizinische Universität Graz (Neue Stiftingtalstr.6, West, Q/04, 8010 Graz, Austria; +43 (0)316 385 13928; ethikkommission@medunigraz.at), ref: 36-121 ex 23/24 |
| Health condition(s) or problem(s) studied | Acute or chronic cranio-cervical junction instability due to, but not limited to: Trauma: Atlanto-occipital dislocation, occipital condyle fracture, atlas, and axis fractures; Inflammation/autoimmune disease: Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, inflammatory bowel disease-associated arthropathy, tuberculosis, osteomyelitis; Neoplasm: Metastasis, chordoma, Ewing tumor, osteoblastoma, osteochondroma, hemangioma, aneurysmal bone cyst; Congenital: Chiari malformation with basilar invagination, Down’s syndrome, Klippel–Feil syndrome, Morquio’s syndrome, os odontoideum; Iatrogenic: After odontoidectomy, failed previous attempts at C1–C2 fusion, after the far lateral approach with occipital condyle resection. |
| Intervention | Any patient who has received a Perla Occipital system in the participating center will be asked for the data collection of their retrospective data. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Perla® Occipital System |
| Primary outcome measure | 1. Spinal stability assessed by measuring the COBB angle on radiological images. The stability will be achieved by a maximum change of 5° of the COBB angle of the first postoperative follow-up (up to 4 months) interim (4-10 months) and last follow-up (after 10 months) radiological exams compared to the immediate postoperative radiological exams 2. Fusion (solid, fibrous, non-union) assessed with radiological images at interim postoperative follow-up (4-10 months) and last follow-up (after 10 months) 3. Clinical and neurological assessment will be evaluated with the Modified Japanese Orthopaedic Association (mJOA) scale. The mJOA scores at immediate postoperation, first follow-up (up to 4 months) interim (4-10 months) and last follow up (after 10 months) will be compared to the pre-operative score. Additionally, score groups analysis over time will be assessed (scores 0-11; 12-14; 15-18). 4. Absence of adjacent segment disease will be assessed with clinical and radiological assessments at interim postoperative follow-up (4-10 months) and last follow-up (after 10 months) 5. Safety evaluation: The incidence of AEs related to the device and/or procedure will be recorded from the surgery through the last post-operative follow-up visit. All perioperative and postoperative adverse device effects (ADEs) (including serious adverse device effects [SADEs] and unanticipated serious adverse device effects [USADEs]) will be assessed for the relationship to device and procedure, seriousness, incidence, and time to resolution or re-operation. The incidence of re-intervention at the index level will be assessed. The incidence of device deficiencies that might have led to a SADE will be recorded from the surgery through the last post-operative follow-up visit. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/06/2022 |
| Completion date | 03/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 20 |
| Total final enrolment | 15 |
| Key inclusion criteria | 1. Patients who received the PERLA® Occipital system to treat a cranio-cervical instability of any cause and indicated for occipito-cervical fusion 2. Non-opposition/consent for retrospective data collection |
| Key exclusion criteria | Current exclusion criteria as of 19/02/2024: Does not meet the inclusion criteria. Previous exclusion criteria: Less than 6 months of post-operative follow-up |
| Date of first enrolment | 09/03/2023 |
| Date of final enrolment | 26/05/2024 |
Locations
Countries of recruitment
- Austria
- France
- Germany
Study participating centres
Toulon
83000
France
Donauwörth
86609
Germany
Bruck an der Mur
8600
Austria
Sponsor information
Industry
Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland
| Phone | +33 (0)225701200 |
|---|---|
| clinic@spineart.com | |
| Website | https://www.spineart.com/ |
"ROR" |
https://ror.org/05sz2c652 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 31/12/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The dataset generated and analysed during the current study will be available upon request from clinic@spineart.com |
Editorial Notes
11/04/2025: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment start date was changed from 02/01/2023 to 09/03/2023.
3. The recruitment end date was changed from 31/05/2024 to 26/05/2024.
4. The overall study end date was changed from 31/12/2024 to 03/07/2024.
5. Total final enrolment added.
19/02/2024: The following changes were made to the study record:
1. The public title was changed from 'Neck stabilization using the PERLA® fixation system' to 'Neck stabilization using the PERLA® Occipital fixation system'.
2. The exclusion criteria were updated.
3. The study participating centre Landeskrankenhaus Hochsteiermark, Standort Leoben was replaced with Landeskrankenhaus Hochsteiermark, Standort Bruck.
4. Ethics approval details added.
5. The recruitment end date was changed from 31/12/2024 to 31/05/2024.
16/02/2023: The study setting has been changed from ‘Other’.
20/01/2023: Trial website added.
15/12/2022: Trial's existence confirmed by the Health Data Hub.
