Trial Outcomes & Findings for Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation (NCT NCT02068768)

NCT ID: NCT02068768

Last Updated: 2019-07-05

Results Overview

Number of participants with fused disc space as measured radiographically

• Recruitment status: TERMINATED
• Target enrollment: 13 participants
• Primary outcome timeframe: 12 months after device implantation
• Results posted on: 2019-07-05

Participant Flow

Participant milestones

Measure	Operated Subjects Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Overall Study STARTED	13
Overall Study COMPLETED	6
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	Operated Subjects Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Overall Study Lost to Follow-up	5
Overall Study Early Termination by Sponsor	2

Baseline Characteristics

Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation

Baseline characteristics by cohort

Measure	Operated Subjects n=13 Participants Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Age, Continuous	54.5 Years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants
BMI (kg/m^2)	31.5 kg/m^2 n=5 Participants
Previous Lumbar Surgery	4 Participants n=5 Participants
Surgical Level L2-L3	3 Participants n=5 Participants
Surgical Level L3-L4	3 Participants n=5 Participants
Surgical Level L4-L5	6 Participants n=5 Participants
Surgical Level L2-L4	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months after device implantation

Population: Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis.

Number of participants with fused disc space as measured radiographically

Outcome measures

Measure	Operated Subjects n=3 Participants Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Fusion Rate	3 Participants

SECONDARY outcome

Timeframe: preop, 3 mo, 6 mo, 12 mo post op

Population: Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months

The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.

Outcome measures

Measure	Operated Subjects n=13 Participants Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Mean Oswestry Disability Index (ODI) Preop	53 score on a scale Interval 40.0 to 72.0
Mean Oswestry Disability Index (ODI) 3 months	46 score on a scale Interval 20.0 to 57.0
Mean Oswestry Disability Index (ODI) 6 months	45 score on a scale Interval 18.0 to 56.0
Mean Oswestry Disability Index (ODI) 12 months	37 score on a scale Interval 0.0 to 47.0

SECONDARY outcome

Timeframe: preop, 3 mo, 6 mo, 12 mo

Population: Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months

The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.

Outcome measures

Measure	Operated Subjects n=13 Participants Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Visual Analog Scale (VAS) of Back Pain Preop	77 units on a scale Interval 37.0 to 100.0
Visual Analog Scale (VAS) of Back Pain 3 months	42 units on a scale Interval 5.0 to 75.0
Visual Analog Scale (VAS) of Back Pain 6 months	29 units on a scale Interval 0.0 to 67.0
Visual Analog Scale (VAS) of Back Pain 12 months	23 units on a scale Interval 0.0 to 71.0

Adverse Events

Operated Subjects

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Operated Subjects n=13 participants at risk Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Avenue® L Interbody Fusion System (LDR Spine): PEEK, intervertebral cage for interbody fusion of the lumbar spine
Musculoskeletal and connective tissue disorders Back Pain	15.4% 2/13 • Number of events 3 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Metabolism and nutrition disorders Dehydration	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Musculoskeletal and connective tissue disorders Flank pain	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Nervous system disorders Headache	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Musculoskeletal and connective tissue disorders Hernia	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Vascular disorders Hypotension	7.7% 1/13 • Number of events 2 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Psychiatric disorders Insomnia	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Cardiac disorders Ischemia	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Musculoskeletal and connective tissue disorders Neck pain	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Musculoskeletal and connective tissue disorders Pain in extremity	15.4% 2/13 • Number of events 2 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Nervous system disorders Peripheral sensory neuropathy	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Investigations Seroma	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)
Infections and infestations Urinary tract infection	7.7% 1/13 • Number of events 1 • From time of surgery through 12 months post op All events deemed adverse in nature were reported. When available, a diagnosis was recorded versus a symptom. Events were assessed for relatedness to the device and include a brief description of treatment and outcome (ongoing or resolved)

Additional Information

Clinical Affairs

Zimmer Biomet Spine

Phone: 303-501-8571

Email: tammy.stinson2@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place