Neck stabilization using the PERLA® Occipital fixation system

Occipitocervical spine stabilization using PERLA® posterior occipito-cervico-thoracic fixation. A post-market clinical follow-up study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN82579275

Enrollment

Registered

2022-12-15

Start date

2023-03-09

Completion date

Unknown

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute or chronic cranio-cervical junction instability due to, but not limited to: Trauma: Atlanto-occipital dislocation, occipital condyle fracture, atlas, and axis fractures

Interventions

Any patient who has received a Perla Occipital system in the participating center will be asked for the data collection of their retrospective data.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
There are no secondary outcome measures	—

Countries

Austria, France, Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jun 21, 2026