Fusion Assessment Clinical Trial (FACT)

Flexuspine

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Procedure: Spinal fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT00736398

01000-T02

Details and patient eligibility

About

This is an observational study to assess clinical outcomes in patients who undergo spinal fusion. Patients who are already scheduled for spinal fusion will enroll in the study. Information about prior therapies will be collected, and then patients will be followed to see how they do after spinal fusion. This study will help researchers better understand the natural course of patients who patients who undergo spinal fusion surgery.

Enrollment: 50 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Lumbar DDD
• Candidate for spinal fusion
• Provide written informed consent

Exclusion criteria

• Prior lumbar spinal fusion
• Metabolic bone disease
• Morbid obesity
• Systemic infection or active malignancy
• Pregnancy

Trial design

50 participants in 1 patient group

Observation

Description:

Spinal fusion

Treatment:

Procedure: Spinal fusion