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

NCT01944345 | Completed Results

• 1 other identifier: 2012-001, Ver3
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50

  ODI/NDI Score Range: 0-50 0-4 No disability 5-14 Mild disability 15-24 Moderate disability 25-34 Severe disability \>34 Complete disability

  Pre-operative and Post-operative 12 months post-operative

• Change in VAS Pain

  VAS Pain comparison Preoperative vs post-operative of greater than or equal to 6. VAS PAIN SEVERITY SCALE ranges from 0-10. A score of zero (0) means 'no pain' and a ten (10) means 'worst imaginable pain'

  Pre-operative and Post-operative 12 months

Secondary Outcomes (1)

• Radiological Assessment

  Post-operative follow up

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing spinal fusion using VariLift lumbar or cervical devices must be screened by the investigating surgeon for eligibility into the registry using the primary diagnosis parameters and the inclusion/exclusion criteria. In addition physicians must follow the associated VariLift Instructions for Use.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wenzel Spine: lead

Study Sites (3)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Foundation Surgical Hospital

San Antonio, Texas, 78229, United States

Location

Methodist Hospital

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Spondylolisthesis; Lymphoma, Follicular; Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director, Quality & Regulatory Affairs
• Organization: Wenzel Spine, Inc.

bnowatzke@wenzelspine.com

5123148271

Study Officials

• Warren Neely, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 17, 2013
• Study Start: June 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: May 17, 2016
• Results First Posted: April 14, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)