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

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

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.

Study Overview

• Status: Completed
• Conditions: Lumbar or Thoraco-lumbar Adult Deformity
• Intervention / Treatment: Device: Polyaxial posterior spinal fusion system

• Study Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Santy orthopedic center
• United States
  • Colorado
    • Denver, Colorado, United States, 80045
      • UC Denver

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult with a lumbar or thoraco-lumbar spine deformity

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lumbar or thoraco-lumbar Adult Deformity	Device: Polyaxial posterior spinal fusion system; posterior correction and fusion of the thoraco-lumbar or lumbar spine; Other Names: PASS® LP system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correction of the sagittal parameters	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)	preop, 24 months
improvement of Quality of life	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)	preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the device	Per and Post-operative device complications: Screw pull-out Loosening, breakage and pseudarthrosis based on x-rays analysis	preop, 3 months, 6 months, 12 months, 24 months
Complications associated with the surgery	Peri-operative data: length of operative time, length of correction time, blood loss … Surgical complications	preop, 3 months, 6 months, 12 months, 24 months
Coronal correction	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)	preop, 3 months, 6 months, 12 months, 24 months
Vertebra rotation	A pre/post-operative comparison of Rotary Vertebra Subluxation (olisthesis); A pre/post-operative comparison of Apical Vertebra Rotation (AVR) - Nash Moe	preop, 24 months
Adjacent levels degeneration	preoperative and post-operative comparison of the disc height of the upper and lower adjacent levels	preop, 24 months
Fusion	standing X-Rays observations (osseous formation)	preop, 24 months

Collaborators and Investigators

• Sponsor: Medicrea International
• Investigators: Principal Investigator: Evalina BURGER, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: March 1, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: adult; lumbar; deformity; Oswestry Disability Index (ODI); thoraco-lumbar; Sagittal vertebral Alignement (SVA)
• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: 0309 (Klein Buendel, Inc.)