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

Intervertebral Disc Degeneration Clinical Trial

Official title:

VariLift Lumbar and Cervical Patient Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01944345
• Other study ID #: 2012-001, Ver3
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: October 5, 2015
• Start date: June 2013
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Wenzel Spine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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, immediate post-op, 3, 6, and 12 months post-operative.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patient is undergoing a procedure with unilateral or bilateral placement of VariLift

• This is the first surgery at the index level

• Patient has understood and signed the informed consent

• Patient is skeletally mature

Exclusion Criteria:

• Revision Surgery

• Is a Worker's Compensation Case

• Infection at the operative site

• Sustained trauma with instability

• Sustained fracture of the vertebra at any of the lumbar spinal levels

• Has a primary diagnosis of degenerative or isthmic spondylolisthesis greater than Grade 1

• Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or drug abuse)

• Has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the clinical study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy, metastasis to vertebrae, adult onset diabetes, active rheumatoid arthritis, etc.)

• Is an immunologically suppressed or receiving steroid in excess of usual doses

• Is obese (as defined by a Body Mass Index (BMI) of > 40 kg/m2 (BMI equals (weight in pounds x 703) / (height in inches x height in inches))

• Has disabling and daily narcotic dependency greater than 18 months

• Has a known malignancy

• Has a known allergy to metal implants

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Foundation Surgical Hospital	San Antonio	Texas
United States	Methodist Hospital	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Wenzel Spine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Oswestry Disability Index/Neck Disability Index		Pre-operative vs. Post-operative 6 weeks, 3, 6, and 12 months post-operative	No
Primary	Change in VAS Pain		Pre-operative vs. Post-operative 6 weeks, 3, 6, 12 months	No
Secondary	Radiological Assessment	Determination of fusion assessment, subsidence or migration of the device.	Post-operative follow up	No