Clinical trial NCT01635322: Sagittal Plane Correction With Pass-LP Device in Adult Deformity Patients
Official title: The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar or Thoraco-lumbar Adult Deformity
Keywords: deformity
adult
lumbar
thoraco-lumbar
Sagittal vertebral Alignement (SVA)
Oswestry Disability Index (ODI)
Lead sponsor: Medicrea International
Sponsor class: INDUSTRY
First posted: 2012-07-09
Enrollment: 54
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult with a lumbar or thoraco-lumbar spine deformity

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Correlation between correction of SVA and improvement ODI
timeFrame: preop, 3 months, 6 months, 12 months, 24 months
Secondary outcomes:
measure: Correction of the sagittal parameters
timeFrame: preop, 24 months
measure: improvement of Quality of life
timeFrame: preop, 3 months, 6 months, 12 months, 24 months
measure: Complications associated with the device
timeFrame: preop, 3 months, 6 months, 12 months, 24 months
measure: Complications associated with the surgery
timeFrame: preop, 3 months, 6 months, 12 months, 24 months
measure: Coronal correction
timeFrame: preop, 3 months, 6 months, 12 months, 24 months
measure: Vertebra rotation
timeFrame: preop, 24 months
measure: Adjacent levels degeneration
timeFrame: preop, 24 months
measure: Fusion
timeFrame: preop, 24 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: UC Denver
state: Colorado
city: Lyon
country: France
facility: Santy orthopedic center
Study officials:
affiliation: University of Colorado, Denver
name: Evalina BURGER, MD
role: PRINCIPAL_INVESTIGATOR
References: