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

Completed

Conditions studied: Lumbar or Thoraco-lumbar Adult Deformity

In brief

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.

Key facts

Study ID

NCT01635322

Run by

Medicrea International

People needed

54

Starts

2012-07-01

Expected to finish

2016-11-01

Last updated by the study team

2017-03-28

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Denver — Denver, Colorado, United States
• Santy orthopedic center — Lyon, France

Full record on ClinicalTrials.gov

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