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Trial record 2 of 108 for:    ADULT SCOLIOSIS

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medicrea International
ClinicalTrials.gov Identifier:
NCT01635322
First received: March 1, 2012
Last updated: November 18, 2014
Last verified: July 2012
  Purpose

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.


Condition Intervention
Lumbar or Thoraco-lumbar Adult Deformity
Device: Polyaxial posterior spinal fusion system

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Relationship Between Sagittal Plane Correction and Quality of Life in Adult Deformity Patients Treated With Posterior Instrumentation

Further study details as provided by Medicrea International:

Primary Outcome Measures:
  • Correlation between correction of SVA and improvement ODI [ Time Frame: preop, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • Correction of the sagittal parameters [ Time Frame: preop, 24 months ] [ Designated as safety issue: No ]

    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)

  • improvement of Quality of life [ Time Frame: preop, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    • 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)

  • Complications associated with the device [ Time Frame: preop, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: Yes ]

    Per and Post-operative device complications:

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


  • Complications associated with the surgery [ Time Frame: preop, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: Yes ]
    Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications

  • Coronal correction [ Time Frame: preop, 3 months, 6 months, 12 months, 24 months ] [ Designated as safety issue: No ]
    • 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)

  • Vertebra rotation [ Time Frame: preop, 24 months ] [ Designated as safety issue: No ]
    • A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis)
    • A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe

  • Adjacent levels degeneration [ Time Frame: preop, 24 months ] [ Designated as safety issue: No ]
    preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels

  • Fusion [ Time Frame: preop, 24 months ] [ Designated as safety issue: No ]
    standing X-Rays observations (osseous formation)


Estimated Enrollment: 125
Study Start Date: July 2012
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Lumbar or thoraco-lumbar Adult Deformity
Lumbar or thoraco-lumbar Adult Deformity
Device: Polyaxial posterior spinal fusion system
posterior correction and fusion of the thoraco-lumbar or lumbar spine
Other Name: PASS® LP system

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult with a lumbar or thoraco-lumbar spine deformity

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01635322

Locations
United States, Colorado
UC Denver
Denver, Colorado, United States, 80045
France
Santy orthopedic center
Lyon, France, 69008
Sponsors and Collaborators
Medicrea International
Investigators
Principal Investigator: Evalina BURGER, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: Medicrea International
ClinicalTrials.gov Identifier: NCT01635322     History of Changes
Other Study ID Numbers: 0309
Study First Received: March 1, 2012
Last Updated: November 18, 2014
Health Authority: United States: Institutional Review Board
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Conseil National de l'Ordre des Médecins
France: French Data Protection Authority

Keywords provided by Medicrea International:
deformity
adult
lumbar
thoraco-lumbar
Sagittal vertebral Alignement (SVA)
Oswestry Disability Index (ODI)

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 20, 2014