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Completed

NCT Number: NCT01635322

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

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.

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Key information

Conditions

Lumbar or Thoraco-lumbar Adult Deformity Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Santy orthopedic center, Lyon, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyaxial posterior spinal fusion system

Device

posterior correction and fusion of the thoraco-lumbar or lumbar spine

Other names: PASS® LP system

Primary outcomes

  1. Correlation between correction of SVA and improvement ODI

    Time frame: preop, 3 months, 6 months, 12 months, 24 months

    The primary objective is to evaluate the correlation between:

    • the correction of the Sagittal Vertical Alignement (SVA), expressed in centimeters - SVA is the distance between C7 plumbline and the posterior of the superior endplate of S1)
    • the improvement of the Oswestry Disability Index (ODI) is the positive difference of the preoperative score and the postoperative score - expressed in % or a score (/50)

Secondary outcomes

  1. Correction of the sagittal parameters

    Time frame: preop, 24 months

    Sagittal parameters are evaluated by:

    • Cobb angle: Thoracic kyphosis measured from T5 to T12 and between the 2 inflexion points of the curve Lumbar lordosis measured from T12 to S1 and between the 2 inflexion points of the curve
    • Pelvic Incidence (PI)
    • Pelvic Tilt (PT)
    • Sacral Slope (SS)
    • Proximal junction Cobb angle
    • T1 spinopelvic inclination (T1-SPI)

  2. improvement of Quality of life

    Time frame: preop, 3 months, 6 months, 12 months, 24 months

    • The effect that the patient's pathology has on his/her daily life evaluated by the Scoliosis Research Society (SRS-22) questionnaire designed and recommended by the Scoliosis Research Society
    • Pain reduction for back and leg by the Visual Analogue Scale (VAS)
    • Patient satisfaction with the results of their operation using a simple questionnaire (Patient Satisfaction Index - PSI) which was designed and recommended by the North American Spine Society (NASS)

  3. Complications associated with the device

    Time frame: preop, 3 months, 6 months, 12 months, 24 months

    Per and Post-operative device complications:

    Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis

  4. Complications associated with the surgery

    Time frame: preop, 3 months, 6 months, 12 months, 24 months

    Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications

  5. Coronal correction

    Time frame: preop, 3 months, 6 months, 12 months, 24 months

    • A pre/post-operative comparison of regular Cobb angles
    • A pre/post-operative comparison of C7 plumb line (Coronal balance)
    • A pre/post-operative comparison of Apical Vertebra Translation (AVT)

  6. Vertebra rotation

    Time frame: preop, 24 months

    • A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis)
    • A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe

  7. Adjacent levels degeneration

    Time frame: preop, 24 months

    preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels

  8. Fusion

    Time frame: preop, 24 months

    standing X-Rays observations (osseous formation)

Sponsors and collaborators

Lead sponsor

Medicrea International

Industry

Registry information

Official study title

The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2012
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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