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

Completed

• Conditions: Lumbar or Thoraco-lumbar Adult Deformity
• Interventions: Device: Polyaxial posterior spinal fusion system

• Registration Number: NCT01635322
• Lead Sponsor: Medicrea International

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-01
• Study Start: 2012-07
• Study First Submitted QC: 2012-07-06
• Study First Posted: 2012-07-09
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-27
• Last Update Posted: 2017-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lumbar or thoraco-lumbar Adult Deformity	Polyaxial posterior spinal fusion system	Lumbar or thoraco-lumbar Adult Deformity

Primary Outcome Measures

Name	Time	Method
Correlation between correction of SVA and improvement ODI	preop, 3 months, 6 months, 12 months, 24 months	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

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

Trial Locations

Locations (2)

UC Denver; 🇺🇸 Denver, Colorado, United States

Santy orthopedic center; 🇫🇷 Lyon, France