NCT01019109

Brief Summary

The purpose of this study is to find out the outcomes of using the PASS LP System to correct idiopathic scoliosis. This system is a unique set of spinal instrumentation used to surgically correct the rotation and deformity of the spine that is caused by scoliosis. Also, this study wants to find out the effects this system has on the physical appearance and quality of life for patients with scoliosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 21, 2018

Status Verified

March 1, 2018

Enrollment Period

6.2 years

First QC Date

November 20, 2009

Last Update Submit

March 20, 2018

Conditions

Idiopathic Scoliosis

Keywords

scoliosis

Outcome Measures

Primary Outcomes (1)

  • Tridimensional radiographic correction of the scoliosis in coronal, sagittal and transverse planes

    Preoperative, 6 weeks, 6 months, 1 year and 2 Years

Secondary Outcomes (2)

  • Functional and aesthetic outcomes

    Preoperative, 6 months and 2 years

  • Perioperative and postoperative complications

    Continuous during follow-up

Study Arms (2)

Titanium rod

Titanium rods used as a part of PSF construct

Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.

CoCr Rod

Cobalt Chrome rods used as a part of PSF construct

Device: Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.

Interventions

Posterior Spinal Fusion Device: Titanium rod arm used titanium rods, and CoCr rod arm used Cobalt Chrome rods as a part of the construct.DEVICE

PASS LP Implant System is designed to contribute to correction and surgical stabilization of the thoracic, lumbar and sacral spine only. These implants are designed to stabilize the spine during normal development of solid bony consolidation which takes about 18 months. The internal fixation devices are composed of screws, hooks,rods, plates, cross links, connection and locking devices. The range of different sizes and shapes of the implants allows the surgeon to adapt to the pathology and morphology of each of his patients.

Also known as: PASS® LP Spinal System, Low Profile Polyaxial Spine System, Pedicular Screw System
CoCr RodTitanium rod

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Surgeon's Practice/Clinic

You may qualify if:

  • Idiopathic scoliosis requiring posterior spinal instrumentation and fusion
  • Male and female

You may not qualify if:

  • Neuromuscular or degenerative scoliosis
  • Spinal cord abnormalities with any neurologic symptoms or signs
  • Spinal cord lesions requiring neurosurgical interventions, such as hydromyelia requiring Arnold Chiari decompression
  • Primary muscle diseases, such as muscular dystrophy
  • Neurologic diseases (e.g. Charcot-Marie Tooth, Guillain-Barre syndrome, cerebral palsy, or spina bifida, Neurofibroma)
  • Primary abnormalities of bones (e.g. osteogenesis imperfecta)
  • Congenital scoliosis
  • Scoliosis requiring anterior release
  • Previous spinal surgery
  • Patient who is unable to complete a self-administered patient questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

LSU Health Sciences Center

New Orleans, Louisiana, 70112, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • Dennis Devito, M.D.

    Children's Healthcare of Atlanta, GA

    PRINCIPAL INVESTIGATOR

  • Andrew King, M.D.

    LSU Health Sciences Center-New Orleans, LA

    PRINCIPAL INVESTIGATOR

  • Mark Willits, M.D.

    Nationwide Children's Hospital- Columbus, OH

    PRINCIPAL INVESTIGATOR

  • Afshin Aminian, MD

    Chilren's Hospital of Orange County

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 20, 2009

First Posted

November 25, 2009

Study Start

May 1, 2010

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 21, 2018

Record last verified: 2018-03

Locations

US(3)