Neck stabilization using the PERLA® Occipital fixation system

ISRCTN	ISRCTN82579275
DOI	https://doi.org/10.1186/ISRCTN82579275
ClinicalTrials.gov (NCT)	Nil known
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	P69_CLD002
Sponsor	Spineart (Switzerland)
Funder	Spineart SA

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Mrs Dervilla Bermingham
Scientific

Chemin du Pré-Fleuri 3
Plan-les-Ouates
1228
Switzerland

Phone	+33 (0)225701200
Email	dbermingham@spineart.com

Study information

Primary study design	Observational
Study design	Real-world evidence retrospective multicentric international single-arm post-market clinical follow-up study
Secondary study design	Retrospective study
Study type	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
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Perla® Occipital System
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	There are no secondary outcome measures
Completion date	03/07/2024

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

HIA Sainte Anne - Toulon

2 Bd Sainte-Anne
Toulon
83000
France

Klinik für Orthopädie, Unfallchirurgie und Wirbelsäulentherapie Donau-Ries Klinik Donauwörth

Neudegger Allee 6
Donauwörth
86609
Germany

Landeskrankenhaus Hochsteiermark, Standort Bruck

Tragösser Str. 1
Bruck an der Mur
8600
Austria

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
IPD sharing plan	The dataset generated and analysed during the current study will be available upon request from clinic@spineart.com

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes

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.