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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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Conditions

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Lumbar or Thoraco-lumbar Adult Deformity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lumbar or thoraco-lumbar Adult Deformity

Polyaxial posterior spinal fusion system

Intervention Type DEVICE

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

Interventions

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Polyaxial posterior spinal fusion system

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

Intervention Type DEVICE

Other Intervention Names

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PASS® LP system

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No