Trial Outcomes & Findings for Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device (NCT NCT01944345)

Results Overview

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

Recruitment status

COMPLETED

Target enrollment

69 participants

Primary outcome timeframe

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

Results posted on

2016-05-17

Participant Flow

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

Participant milestones

Participant milestones
Measure	Registry Patients Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Overall Study STARTED	69
Overall Study COMPLETED	69
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Registry Patients n=69 Participants Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	44 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	29 Participants n=5 Participants
Region of Enrollment United States	69 participants n=5 Participants
BMI < 40kg/m^2	69 participants n=5 Participants

PRIMARY outcome

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

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

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

Outcome measures

Outcome measures
Measure	Registry Patients n=69 Participants Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 NDI Score Pre-Surgery	20.07 Units on a scale 0-50 Standard Deviation 9.37
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 NDI Score at 12 Months	5.61 Units on a scale 0-50 Standard Deviation 8.15
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 ODI Score at Pre-Surgery	19.27 Units on a scale 0-50 Standard Deviation 5.33
Change in Oswestry Disability Index (ODI)/Neck Disability Index (NDI) Score Range 0-50 ODI Score at 12 Months	10.41 Units on a scale 0-50 Standard Deviation 7.20

PRIMARY outcome

Timeframe: Pre-operative and Post-operative 12 months

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

Outcome measures

Outcome measures
Measure	Registry Patients n=69 Participants Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Change in VAS Pain Cervical Preoperative	3.53 Units on a scale 0-10 Standard Deviation 1.01
Change in VAS Pain Cervical Postoperative	1.03 Units on a scale 0-10 Standard Deviation 0.38
Change in VAS Pain Lumbar Preoperative	5.85 Units on a scale 0-10 Standard Deviation 0.49
Change in VAS Pain Lumbar Postoperative	2.16 Units on a scale 0-10 Standard Deviation 0.25

SECONDARY outcome

Timeframe: Post-operative follow up

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

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

Outcome measures

Outcome measures
Measure	Registry Patients n=69 Participants Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Radiological Assessment Cervical Fusion at 12M	26 participants
Radiological Assessment Cervical Subsidence/Migration (>3mm)	0 participants
Radiological Assessment Lumbar Fusion at 12M	29 participants
Radiological Assessment Lumbar Subsidence/Migration (>3mm)	1 participants

Adverse Events

Registry Patients

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Registry Patients n=69 participants at risk Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
Social circumstances Other Not Device Related	31.9% 22/69 • Number of events 27 • Preoperative versus 12 months Postoperative Events were assessed with each follow-up appointment and as reported by participant.

Additional Information

Director, Quality & Regulatory Affairs

Wenzel Spine, Inc.

Phone: 5123148271

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60