NCT01635322

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2012

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4.3 years

First QC Date

March 1, 2012

Last Update Submit

March 27, 2017

Conditions

Lumbar or Thoraco-lumbar Adult Deformity

Keywords

deformityadultlumbarthoraco-lumbarSagittal vertebral Alignement (SVA)Oswestry Disability Index (ODI)

Outcome Measures

Primary Outcomes (1)

  • Correlation between correction of SVA and improvement ODI

    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)

    preop, 3 months, 6 months, 12 months, 24 months

Secondary Outcomes (8)

  • Correction of the sagittal parameters

    preop, 24 months

  • improvement of Quality of life

    preop, 3 months, 6 months, 12 months, 24 months

  • Complications associated with the device

    preop, 3 months, 6 months, 12 months, 24 months

  • Complications associated with the surgery

    preop, 3 months, 6 months, 12 months, 24 months

  • Coronal correction

    preop, 3 months, 6 months, 12 months, 24 months

  • +3 more secondary outcomes

Study Arms (1)

Lumbar or thoraco-lumbar Adult Deformity

Lumbar or thoraco-lumbar Adult Deformity

Device: Polyaxial posterior spinal fusion system

Interventions

Polyaxial posterior spinal fusion systemDEVICE

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

Also known as: PASS® LP system
Lumbar or thoraco-lumbar Adult Deformity

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult with a lumbar or thoraco-lumbar spine deformity

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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

UC Denver

Denver, Colorado, 80045, United States

Location

Santy orthopedic center

Lyon, 69008, France

Location

MeSH Terms

Conditions

Congenital Abnormalities

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Evalina BURGER, MD

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2012

First Posted

July 9, 2012

Study Start

July 1, 2012

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(1)FR(1)