Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients

Medicrea

Status: Completed

Conditions: Lumbar or Thoraco-lumbar Adult Deformity

Treatments: Device: Polyaxial posterior spinal fusion system

Study type: Observational

Funder types: Industry

Identifiers

NCT01635322

0309

Details and patient eligibility

About

The purpose of this study is to evaluate the correlation between the restoration of the sagittal balance and the improvement of the Quality of Life for patients with adult scoliosis, treated with a polyaxial system (PASS® LP system) during the 2 years after a spinal fusion surgery.

Enrollment: 54 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

• Lumbar or thoraco-lumbar Adult Deformity requiring posterior spinal instrumentation and fusion like:

  • Scoliosis
  • Kyphosis
  • Kyphoscoliosis

• Patient with a Cobb angle ≥ 30° and/or confirmed sagittal imbalance defined as sagittal vertical axis (SVA) more or equal to 5cm and/or a loss of lumbar lordosis versus the pelvic incidence

• Patient ≥ 21 years old

• Surgery that requires 4 or more levels to be operated

• Patient with complete pre-operative radiographic data: antero-posterior and lateral standing full spine x-rays (from hips to C2) and lateral bending x-rays (standing)

• Patient able to complete a self-administered questionnaire

• Patient able to sign a consent form

Exclusion criteria

• Patient operated with posterior spinal fusion without PASS LP device
• Patients who required a Vertebral Column Resection technique surgery
• Neuromuscular scoliosis or diseases and any neuro-related pathology
• Spinal cord abnormalities with any neurologic symptoms or signs
• Primary abnormalities of bones (e.g. osteogenesis imperfecta)
• Recent significant trauma
• Patient is involved in current medical litigation
• Metabolic spinal pathology
• Pathologic obesity (BMI > 40)
• Patients with infection (in particularly osteomyelitis)
• Patient < 21 years old
• Pregnancy or intended to get pregnant during the next 3 years
• Insulin-dependent diabetes
• All other contra-indications given in the PASS® LP System instructions for use
• Patient unable to sign an informed consent form
• Patient unable to complete a self-administered questionnaire

Trial design

54 participants in 1 patient group

Lumbar or thoraco-lumbar Adult Deformity

Description:

Lumbar or thoraco-lumbar Adult Deformity

Treatment:

Device: Polyaxial posterior spinal fusion system