Prospective, Multi-Center Adult Spinal Deformity Outcomes Database Registry (PON)

Shay Bess

Status: Active, not recruiting

Conditions: Spinal Deformity

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00738439

1-08-1850

Details and patient eligibility

About

The clinical, radiographic, and HRQL outcomes will be compared in operative and nonoperative adult spinal deformity patients.

Enrollment: 1,999 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees
• Sagittal Vertical Axis (SVA) > 5cm
• Pelvic Tilt > 25 degrees
• Thoracic kyphosis > 60 degrees
• Age 18 or greater at the time of enrollment.

Exclusion criteria

• Diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital)
• Age <18 yrs at time of surgery or initial consultation

Trial design

1,999 participants in 2 patient groups

Operative

Description:

Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees requiring surgery.

Nonoperative

Description:

Diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees not requiring surgery.