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

• Sponsor: Wenzel Spine (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01944345
• Collaborator: (none)
• Enrollment: 69
• Locations: 3
• Duration (Months): 27
• Patients Per Site: 23
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prolapsed Lumbar Disc; Prolapsed Cervical Disc; Intervertebral Disc Degeneration; Spondylolisthesis, Grade 1; Intervertebral Disc Displacement

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.

Study Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 69 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: VariLift Lumbar and Cervical Patient Registry
• Study Start Date: Jun 1, 2013
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Outcome Measures

Primary Outcome Measures

1. Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 [Pre-operative and Post-operative 12 months post-operative]

   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

2. Change in VAS Pain [Pre-operative and Post-operative 12 months]

   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'

Secondary Outcome Measures

1. Radiological Assessment [Post-operative follow up]

   Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
2	Foundation Surgical Hospital	San Antonio	Texas	United States	78229
3	Methodist Hospital	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Wenzel Spine

Investigators

• Principal Investigator: Warren Neely, MD, The Methodist Hospital Research Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Wenzel Spine
• ClinicalTrials.gov Identifier: NCT01944345
• Other Study ID Numbers: 2012-001, Ver3
• First Posted: Sep 17, 2013
• Last Update Posted: May 17, 2016
• Last Verified: Apr 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Spondylolisthesis; Intervertebral Disc Degeneration; Intervertebral Disc Displacement

Study Results

Participant Flow

Recruitment Details	Multi-site recruitment with up to 1000 patients to be enrolled for entire study across all hospital or ASC sites.

Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Period Title: Overall Study
STARTED	69
COMPLETED	69
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Overall Participants	69
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	44 63.8%
>=65 years	25 36.2%
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	40 58%
Male	29 42%
Region of Enrollment (participants) [Number]
United States	69 100%
BMI < 40kg/m^2 (participants) [Number]
Number [participants]	69 100%

Outcome Measures

1. Primary Outcome

Title	Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50
Description	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
Time Frame	Pre-operative and Post-operative 12 months post-operative

Outcome Measure Data

Analysis Population Description

Combined cervical and lumbar patients: 30 cervical, 39 lumbar. Mean ODI/NDI was calculated for all patients at preop and 12 month.

Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Measure Participants	69
NDI Score Pre-Surgery	20.07 (9.37)
NDI Score at 12 Months	5.61 (8.15)
ODI Score at Pre-Surgery	19.27 (5.33)
ODI Score at 12 Months	10.41 (7.20)

2. Primary Outcome

Title	Change in VAS Pain
Description	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'
Time Frame	Pre-operative and Post-operative 12 months

Outcome Measure Data

Analysis Population Description

Total subjects: 30 Cervical subjects, 39 Lumbar subjects. VAS PAIN SEVERITY SCALE ranges from 0-10. Zero = no pain, 10 - worst imaginable pain

Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Measure Participants	69
Cervical Preoperative	3.53 (1.01)
Cervical Postoperative	1.03 (0.38)
Lumbar Preoperative	5.85 (0.49)
Lumbar Postoperative	2.16 (0.25)

3. Secondary Outcome

Title	Radiological Assessment
Description	Determination of fusion assessment, subsidence or migration of the device and confirmed radiographic dated
Time Frame	Post-operative follow up

Outcome Measure Data

Analysis Population Description

26 (of 30) Cervical Patients 30 (of 39) Lumbar Patients

Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Measure Participants	69
Cervical Fusion at 12M	26 37.7%
Cervical Subsidence/Migration (>3mm)	0 0%
Lumbar Fusion at 12M	29 42%
Lumbar Subsidence/Migration (>3mm)	1 1.4%

Adverse Events

Time Frame	Preoperative versus 12 months Postoperative
Adverse Event Reporting Description	Events were assessed with each follow-up appointment and as reported by participant.
Arm/Group Title	Registry Patients
Arm/Group Description	Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
All Cause Mortality
	Registry Patients
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Registry Patients
	Affected / at Risk (%)	# Events
Total	0/69 (0%)
Other (Not Including Serious) Adverse Events
	Registry Patients
	Affected / at Risk (%)	# Events
Total	22/69 (31.9%)
Social circumstances
Other Not Device Related	22/69 (31.9%)	27

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.