The Perla® TL system is indicated in skeletally mature patients in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine, spondylolisthesis, spinal stenosis, tumor, trauma, and deformities. Musculoskeletal Diseases
Conditions
Interventions
As the primary function, the PERLA® TL system is intended to provide immobilization and stabilization of spinal segments. Sacropelvic is a complex junctional area owing to the complex regional anatomy
Sponsors
Spineart (Switzerland)
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients who meet all inclusion criteria will be enrolled: 1. Patients who received PERLA® TL system to immobilize and stabilize the spino-pelvic segments. 2. Informed Consent Form signed. 3. Patients followed for at least 22 months after their surgery
Exclusion criteria
Exclusion criteria: Patients who meet at least one exclusion criterion will be excluded: 1. Patient under 18 years old 2. Patient who had been deprived of their freedom by administrative or legal decision or who is under guardianship 3. Patient who does not speak/understand French
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Revision/reintervention rate due to device failure or pain, measured using data collected from the patient's medical record within the post-operative follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| The performance of spino-pelvic stabilization with the PERLA® TL System will be evaluated with the measurements of the following radiographic parameters on full spine x-ray or electro-optical system (EOS) x-ray, defined as below: 1. The correction of the sagittal lumbar lordosis (L1-S1) between the preoperative and postoperative follow-up visits 2. Pelvic incidence (PI) at the preoperative and postoperative follow-up visit 3. Pelvic tilt (PT) at the preoperative and postoperative follow-up visit 4. Sacral slope at the preoperative and postoperative follow-up visit 5. Sagittal vertical axis (SVA) at the preoperative and postoperative follow-up visit 6. Thoracic kyphosis (T4-T12) at the preoperative and postoperative follow-up visit 7. Coronal Cobb angle correction (in case of deformity) between the preoperative and postoperative follow-up visit 8. Interbody fusion at the level treated, as applicable (if interbody device implanted), at postoperative follow-up visit 9. Pelvic incidence - lombar lordosis (PI-LL) Mismatch at the preoperative and postoperative follow-up visit The clinical benefits of spino-pelvic stabilization with the PERLA® TL System were evaluated using Patient Reported Outcomes (PRO) with the following endpoints: 1. Pain reduction was measured using the Visual Analog Scale (VAS back and leg) self-reported questionnaire at the postoperative visits compared to the preoperative visit (as applicable) 2. Functional capacity improvement was measured using the Oswestry Disability Index (ODI) self-reported questionnaire at the postoperative visits compared to the preoperative visit (as applicable) | — |
Countries
France
Contacts
Public ContactHouria Belalilt
Outcome results
None listed