Trial Outcomes & Findings for Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion (NCT NCT02018445)

NCT ID: NCT02018445

Last Updated: 2020-02-18

Results Overview

There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 36 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-02-18

Participant Flow

During the study in which each patient undergoes posterolateral fusion (PLF). During PLF, each spinal level is treated with two graft materials, the symptomatic posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral non-symptomtic posterolateral gutter is treated with the control arm (local autograft).

Participant milestones

Measure	All Patients Posterolateral fusion study in which each patient undergoes posterolateral fusion (PLF). During the PLF, each spinal level is treated with two graft materials, the symptomatic posterolateral gutter is treated with study arm (Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Overall Study STARTED	36
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion

Baseline characteristics by cohort

Measure	All Patients n=43 Spinal Levels
Age, Continuous	67.4 years STANDARD_DEVIATION 11.3 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
BMI	28.39 kg/m^2 STANDARD_DEVIATION 5.38 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Time to arthodesis was measured as the mean time to achieve fusion for each spinal level treated.

There were 29 patients and 43 total spinal levels (unit) treated at baseline. Time to arthodesis was measured as the mean time to achieve fusion. At each time point fusion was evaluated, the first time point fusion was achieved was considered fusion.

Outcome measures

Measure	All Patients n=43 Spinal Levels Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.	6 months to fusion Standard Deviation 5.7

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Measure	All Patients n=34 Posterolateral Sides Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan	26 Posterolateral Sides

SECONDARY outcome

Timeframe: 12 months

Population: Patients were lost to follow-up as study progressed

The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by surgeons, clinicians and researchers to quantify disability for low back pain. The questionnaire is self-completed and covers 10 topics about pain intensity, lifting, ability to care for oneself, ability to walk, ability to sit, sexual function, ability to stand, social life, sleep quality, and ability to travel. Scores are from 0-100 and a lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Oswestry Disability Index (ODI) Baseline	47.6 units on a scale Standard Deviation 17.7
Medical Outcomes: Oswestry Disability Index (ODI) 6 Month	26.0 units on a scale Standard Deviation 16.9
Medical Outcomes: Oswestry Disability Index (ODI) 12 Month	25.0 units on a scale Standard Deviation 21.0

SECONDARY outcome

Timeframe: 12 months

Population: Patients lost to follow-up over course of the study.

The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the worst leg pain. A lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS) Baseline	64.8 units on a scale Standard Deviation 28.8
Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS) 6 Month	15.3 units on a scale Standard Deviation 25.7
Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS) 12 Month	13.3 units on a scale Standard Deviation 25.2

SECONDARY outcome

Timeframe: 12 months

Population: Patients were lost to follow-up as study progressed

The visual analogue scale (VAS) is a commonly used outcome measure for research studies. It is presented as a 100- mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "0"/no pain at all" and "100/worst pain imaginable." The study in this scale is used for the back pain. A lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Back Pain Visual Analog Scale (VAS) Baseline Over Time: Baseline	66.1 units on a scale Standard Deviation 30.6
Medical Outcomes: Back Pain Visual Analog Scale (VAS) 6 Month	23.6 units on a scale Standard Deviation 28.4
Medical Outcomes: Back Pain Visual Analog Scale (VAS) 12 Month	22.3 units on a scale Standard Deviation 30.2

SECONDARY outcome

Timeframe: 12 months

Population: Patients were loss to follow-up as clinical study progressed.

EQ-5D is a standardized instrument developed by the EuroQol Group as a measure of health-related quality of life that can be used in a wide range of health conditions and treatments. The EQ-5D consists of a descriptive system and the EQ VAS. The EQ-5D-5l has a descriptive system and the EQ visual analogue scale (EQ VAS). The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Only the EQ VAS Score was analyzed in the study. The EQ VAS scored from 0-100 and a lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS). Baseline	73.0 units on a scale Standard Deviation 21.0
Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS). 6 Month	82.2 units on a scale Standard Deviation 13.5
Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS). 12 Month	81.8 units on a scale Standard Deviation 20.0

SECONDARY outcome

Timeframe: 12 months

Population: NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol.

Posterolateral fusion study in which one spinal level is treated with both the study and control arm. One posterolateral spinal side is Evo3 and the other posterolateral spinal side is local autograft.

NA (Not Applicable): Neurological function data was not able to be analyzed as there was a limitation of the method in the ability to distinguish between left and right side neurological function. Neurological function is indistinguishable between the right and left side of the lower extremities using the methods in the protocol and analysis of neurological function therefore would have made no impact on the outcome of the study.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 24 months

Outcome measures

Measure	All Patients n=36 Participants Posterolateral fusion: each spinal level is treated with two graft materials, the posterolateral gutter is treated with study arm (Accel Evo3) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions	8 Participants

Adverse Events

All Patients

Serious events: 8 serious events

Other events: 17 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=36 participants at risk Patients were treated at multiple levels. Accell Evo3 was placed in the posterolateral gutter of the symptomatic side and local autograft was used in the posterolateral gutter of the contralateral asymptomatic side.
Infections and infestations Infection	5.6% 2/36 • Number of events 2 • 24 months
Musculoskeletal and connective tissue disorders Fall resulting in injury	2.8% 1/36 • Number of events 2 • 24 months
Nervous system disorders Pain	11.1% 4/36 • Number of events 5 • 24 months
Social circumstances Alcohol Abuse	2.8% 1/36 • Number of events 1 • 24 months
Surgical and medical procedures Device (non-study) complication	2.8% 1/36 • Number of events 1 • 24 months
Surgical and medical procedures wound drainage	2.8% 1/36 • Number of events 1 • 24 months

Other adverse events

Measure	All Patients n=36 participants at risk Patients were treated at multiple levels. Accell Evo3 was placed in the posterolateral gutter of the symptomatic side and local autograft was used in the posterolateral gutter of the contralateral asymptomatic side.
Nervous system disorders Pain, stiffness, strain, or discomfort	30.6% 11/36 • Number of events 13 • 24 months
Musculoskeletal and connective tissue disorders Minor fracture	5.6% 2/36 • Number of events 3 • 24 months
Immune system disorders Medication reaction	5.6% 2/36 • Number of events 2 • 24 months
Surgical and medical procedures Device (non-study) Complication	2.8% 1/36 • Number of events 1 • 24 months
Skin and subcutaneous tissue disorders Minor cut	5.6% 2/36 • Number of events 4 • 24 months
Gastrointestinal disorders Impacted bowel	2.8% 1/36 • Number of events 1 • 24 months
Musculoskeletal and connective tissue disorders Muscle tear	2.8% 1/36 • Number of events 1 • 24 months
Musculoskeletal and connective tissue disorders Fall on side with no reported outcome	2.8% 1/36 • Number of events 1 • 24 months
Skin and subcutaneous tissue disorders Rash	2.8% 1/36 • Number of events 1 • 24 months
Surgical and medical procedures Radiographic Haloing of Screws (non-study)	2.8% 1/36 • Number of events 1 • 24 months
Skin and subcutaneous tissue disorders Left ear carcinoma removed	2.8% 1/36 • Number of events 1 • 24 months
Cardiac disorders Elevated blood pressure	2.8% 1/36 • Number of events 1 • 24 months

Additional Information

Sara Tish Mikoczi

SeaSpine

Phone: 760-216-5652

Email: tish.mikoczi@seaspine.com

Results disclosure agreements

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

Restriction type: GT60