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

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

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

Locations

United States, Colorado
UC Denver	Recruiting
Denver, Colorado, United States, 80045
Contact: Cooley, MD Robert.cooley@ucdenver.edu
Principal Investigator: Burger, MD
Sub-Investigator: Patel, MD
Sub-Investigator: Cain, MD
France
Santy orthopedic center	Recruiting
Lyon, France, 69008
Contact: Fiere, MD fiere.vincent@gmail.com
Principal Investigator: Fiere, MD

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:	September 11, 2012
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 May 21, 2013