Trial Outcomes & Findings for OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion (NCT NCT01873586)

NCT ID: NCT01873586

Last Updated: 2019-06-17

Results Overview

Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: up to 24 months
• Results posted on: 2019-06-17

Participant Flow

Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

Unit of analysis: Spinal Levels

Participant milestones

Measure	All Patients Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Overall Study STARTED	29 54
Overall Study COMPLETED	26 47
Overall Study NOT COMPLETED	3 7

Reasons for withdrawal

Measure	All Patients Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Overall Study Lost to Follow-up	3

Baseline Characteristics

OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion

Baseline characteristics by cohort

Measure	All Study Participants n=29 Participants Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Age, Continuous	57 years n=5 Participants
Sex: Female, Male Female	12 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants
Body Mass Index (BMI)	31.6 kg/m^2 STANDARD_DEVIATION 5.0 • n=5 Participants

PRIMARY outcome

Timeframe: up to 24 months

Population: Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

Outcome measures

Measure	All Patients n=54 Posterolateral Gutters Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 3 Month: OsteoStux (symptomatic)	39 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 3 Month: Local Autograft (contralateral)	34 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 6 Month: OsteoStux (symptomatic)	42 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 6 Month : Local Autograft (contralateral)	36 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 12 Month: OsteoStux (symptomatic)	44 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 12 Month: Local Autograft (contralateral)	32 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 24 Month: OsteoStux (symptomatic)	43 Posterolateral Gutters
Number of Posterolateral Gutters That Have Evidence of Arthrodesis (Fusion) at 3, 6, 12, and 24 Months, as Measured by X-rays. 24 Month: Local Autograft (contralateral)	34 Posterolateral Gutters

SECONDARY outcome

Timeframe: 12 months

Population: Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).

Each posterolateral gutter was assessed for extent of fusion using computed tomography (CT) scan.

Outcome measures

Measure	All Patients n=45 Posterolateral gutters Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT 12 Months: OsteoStrux (symptomatic)	39 Posterolateral gutters
Number of Posterolateral Gutters Showing Evidence of Arthrodesis (Fusion) as Measured by CT 12 Months: Local Autograft (contralateral)	32 Posterolateral gutters

SECONDARY outcome

Timeframe: upto 24 months

Population: NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.

NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was indistinguishable per arms, data were not collected due to a limitation in the method of analysis per protocol. Therefore data was not analyzed and outcome is NA.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Population: NA (Not Applicable): As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.

NA (Not Applicable): This post-market study was primarily a posterolateral fusion study. Interbody fusion was a secondary endpoint. As interbody fusion was completed per standard of care, transforaminal lumbar interbody fusion (TLIF), posterolateral fusion (PLF), or posterior lumbar interbody fusion (PLIF) with or without the use of an interbody spacer and any graft material could be used per the Investigator discretion. As interbody fusion was not a primary endpoint and was indistinguishable per control and study arms, interbody fusion results were not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: upto 24 months

Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side".

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 descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels which results in a 1-5 level selected for that dimension. The level when added together describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale. Score is 0-100 and a lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points 6 Months	79.2 units on a scale Standard Deviation 15.6
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points 12 Months	77.4 units on a scale Standard Deviation 17.0
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points 24 Months	72.9 units on a scale Standard Deviation 21.1
EQ-5D Health State Visual Analog Scale (VAS) Questionnaire at All Available Time-points Baseline	58.8 units on a scale Standard Deviation 26.2

SECONDARY outcome

Timeframe: 12 months

Correlation of x-ray with computed tomography scan analysis at the 12 month follow-up time point.

Outcome measures

Measure	All Patients n=40 Posterolateral Gutters Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan OsteoStrux (symptomatic): Agree	37 Posterolateral Gutters
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan OsteoStrux (symptomatic): Disagree	3 Posterolateral Gutters
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan Local Autograft (contralateral): Agree	32 Posterolateral Gutters
Number of Posterolateral Levels With Correlation of Fusion Ratings by X-ray and CT Scan Local Autograft (contralateral): Disagree	8 Posterolateral Gutters

SECONDARY outcome

Timeframe: upto 24 months

Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side".

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 study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. Baseline	50.0 units on a scale Standard Deviation 17.3
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. 6 Months	39.3 units on a scale Standard Deviation 24.6
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. 12 Months	34.6 units on a scale Standard Deviation 22.7
Medical Outcomes: Oswestry Disability Index (ODI), at All Available Time-points. 24 Months	33.7 units on a scale Standard Deviation 25.4

SECONDARY outcome

Timeframe: upto 24 months

Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side".

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=24 Participants Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. Baseline	73.9 units on a scale Standard Deviation 21.6
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. 6 Months	30.5 units on a scale Standard Deviation 34.0
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. 12 Months	29.8 units on a scale Standard Deviation 34.3
Medical Outcomes: Worst Leg Pain on the Visual Analog Scale (VAS) at All Available Time-points. 24 Months	24.4 units on a scale Standard Deviation 30.4

SECONDARY outcome

Timeframe: upto 24 months

Population: Posterolateral fusion study in which one level is treated with both the study and control arm. One side is OsteoStrux combined with bone marrow aspirate (BMA) and the other side is local autograft combined with BMA. Therefore, all results per patient are the same results. All level results are the same unless specifically indicated, "per side".

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 back pain. A lower score represents a better score.

Outcome measures

Measure	All Patients n=29 Participants Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. 12 Months	32.3 units on a scale Standard Deviation 298
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. 24 Months	28.1 units on a scale Standard Deviation 18.5
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. Baseline	70.2 units on a scale Standard Deviation 25.5
Medical Outcomes: Visual Analog Scale (VAS) Back Pain at All Available Time-points. 6 Months	34.7 units on a scale Standard Deviation 30.9

SECONDARY outcome

Timeframe: upto 24 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 posterolateral sides in a neurological function assessment.

Posterolateral fusion study in which one spinal level is treated with both the study and control arm. The symptomatic posterolateral spinal side is OsteoStrux and the contralateral 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 posterolateral sides in a neurological function assessment. Neurological function is indistinguishable between the right and left posterolateral sides of the lower extremities using the methods in the protocol. Therefore, this outcomes measure was not applicable.

Outcome measures

Outcome data not reported

Adverse Events

All Patients

Serious events: 5 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	All Patients n=29 participants at risk Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft). Adverse events are unable to be distinguished per posterolateral gutter or spinal level and therefore results are submitted on a per patient basis.
Surgical and medical procedures bilateral hip replacement	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
Endocrine disorders renal insufficiency	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
Infections and infestations hip infection after hip replacement	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
Surgical and medical procedures cage migration secondary to poor bone quality which required revision	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
Musculoskeletal and connective tissue disorders one episode of increased pain in low back and both legs which required hospitalization w/out surgery	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.
Social circumstances one episode of self-admittance to hospital for 8 days to detox from medication	3.4% 1/29 • Number of events 1 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.

Other adverse events

Measure

All Patients n=29 participants at risk Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft). Adverse events are unable to be distinguished per posterolateral gutter or spinal level and therefore results are submitted on a per patient basis.

Surgical and medical procedures Small Durotomy/Dural Tear

10.3% 3/29 • Number of events 3 • Up to 24 months Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent surgical interventions.

Additional Information

Director Clinical Affairs

SeaSpine

Email: tish.mikoczi@seaspine.com

Results disclosure agreements

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