NCT01944345

Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device

VariLift Lumbar and Cervical Patient Registry

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 69 (actual)
• Sponsor: Wenzel Spine · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.

Detailed description

The registry is design to collect data prospectively on patients undergoing spinal fusion using the VariLift-L, VariLift-A, or VariLift-C device patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered. Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.

Conditions

• Prolapsed Lumbar Disc
• Prolapsed Cervical Disc
• Intervertebral Disc Degeneration
• Spondylolisthesis, Grade 1
• Intervertebral Disc Displacement

Timeline

• Start date: 2013-06-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-09-17
• Last updated: 2016-05-17
• Results posted: 2016-04-14

Locations

3 sites across 1 country: United States