Clinical evaluation after surgery using the PERLA® TL system for the treatment of spinal deformities.

Evaluation of clinical and radiographic outcomes following spinal surgery using the Perla® TL posterior osteosynthesis system for the treatment of spinal deformities over a period of up to 24 months.

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17063858

Enrollment

100

Registered

2025-01-16

Start date

2025-03-19

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

The Perla® TL / Perla® TL MIS, including various types of implant, is suitable for the stabilisation of spinal segments in the surgical treatment of chronic instabilities or deformities of the thoracic, lumbar, and sacral spine of Adolescent Idiopathic Scoliosis (AIS) and Adult Spinal Deformities (ASD) Musculoskeletal Diseases

Interventions

This is a prospective, international, multicentric post-market clinical follow-up study (PMCF) on patients receiving Perla® TL to treat spinal deformities. The study is divided into 2 independent non-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients must meet all the below inclusion criteria (for screening): 1. Patients scheduled for surgery with the Perla® TL system to treat spinal deformities (ASD or AIS) 2. Patients who are willing and able to comply with follow-up visits and fill out questionnaires 3. Written voluntary informed consent signed by the patients and if applicable, their legal representative (for minors) Per-operative inclusion criteria (for enrolment): Patients with the surgery completed with the Perla® TL system

Exclusion criteria

Exclusion criteria: 1. Adult deprived of their freedom by administrative or legal decision or under guardianship 2. Patients with a contraindication as per IFU

Design outcomes

Primary

Measure	Time frame
The clinical benefit of the Perla® TL system will be demonstrated on the Performance Analysis Set by evaluating the Patient Reported Outcomes (PROs) at 12 months post-operatively using the Oswestry Disability Index (ODI) self-reported questionnaire for the ASD (Group 1) and the SRS-22 (Scoliosis Research Society) for the AIS (Group 2). For Group 1 (ASD): The benefit will be confirmed by comparing the ODI scores between preoperative (V1) with scores of 2-6 months visit (V4) and 12 months visit (V5) post-operative. For Group 2 (AIS): The benefit will be evaluated by comparing the SRS-22 questionnaire scores between pre-operative (V1) with scores of 2-6 months visit (V4) and 12 months visit (V5) post-operative.	—

Measure

Time frame

The clinical benefit of the Perla® TL system will be demonstrated on the Performance Analysis Set by evaluating the Patient Reported Outcomes (PROs) at 12 months post-operatively using the Oswestry Disability Index (ODI) self-reported questionnaire for the ASD (Group 1) and the SRS-22 (Scoliosis Research Society) for the AIS (Group 2). For Group 1 (ASD): The benefit will be confirmed by comparing the ODI scores between preoperative (V1) with scores of 2-6 months visit (V4) and 12 months visit (V5) post-operative. For Group 2 (AIS): The benefit will be evaluated by comparing the SRS-22 questionnaire scores between pre-operative (V1) with scores of 2-6 months visit (V4) and 12 months visit (V5) post-operative.

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Secondary

Measure	Time frame
1. To confirm the performance of the Perla® TL system within 24 months post-operatively by quantitatively comparing and assessing the radiological images (Coronal Cobb Angle, Coronal Alignment, Thoracic Kyphosis angle, Lumbar Lordosis angle, Pelvic Incidence, Sacral Slope, Pelvic Tilt, Sagittal Vertical Axis and Odontoid to Hip Axis angle) of the pre-operative visit (V1), discharge (V3), 2-6 months visit (V4), 12 months visit (V5) and 24 months visit (V6). 2. To confirm the clinical benefit of the Perla® TL system within 24 months post-operatively by quantitatively comparing the scores of the PRO questionnaires VAS (back and leg), EQ-5D, Spinal Appearance Questionnaire "SAQ" (only AIS group) and the SRS-22r (only AIS group) or ODI (only ASD group) from baseline (V1) and all post-operative visits (V6). 3. The safety will be assessed by analysing the number of different types of Adverse Event incidences during the study.	—

Measure

Time frame

1. To confirm the performance of the Perla® TL system within 24 months post-operatively by quantitatively comparing and assessing the radiological images (Coronal Cobb Angle, Coronal Alignment, Thoracic Kyphosis angle, Lumbar Lordosis angle, Pelvic Incidence, Sacral Slope, Pelvic Tilt, Sagittal Vertical Axis and Odontoid to Hip Axis angle) of the pre-operative visit (V1), discharge (V3), 2-6 months visit (V4), 12 months visit (V5) and 24 months visit (V6). 2. To confirm the clinical benefit of the Perla® TL system within 24 months post-operatively by quantitatively comparing the scores of the PRO questionnaires VAS (back and leg), EQ-5D, Spinal Appearance Questionnaire "SAQ" (only AIS group) and the SRS-22r (only AIS group) or ODI (only ASD group) from baseline (V1) and all post-operative visits (V6). 3. The safety will be assessed by analysing the number of different types of Adverse Event incidences during the study.

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Countries

France, Spain

Contacts

Public ContactDervilla Bermingham

dbermingham@spineart.com+41 0225701261

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026