Accell Evo3™ Demineralized Bone Matrix in Instrumented Lu... | NCT02018445

NCT02018445

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Label	Type	Description	Intervention Names
Accell Evo3 DBM & Local Autograft	Other	Accell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side)	Procedure: Posterolateral Fusion

Name	Type	Description	Arm Group Labels	Other Names
Posterolateral Fusion	Procedure		Accell Evo3 DBM & Local Autograft

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.	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.	12 months

Secondary Outcomes

Measure	Description	Time Frame
Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan		12 months
Medical Outcomes: Oswestry Disability Index (ODI)	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.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Are 18 (eighteen) years of age or older at the time of surgery.
Require spinal fusion using Transforaminal Lumbar Interbody Fusion (TLIF), Posterior Lumbar Fusion (PLF) or Posterior Lumbar Interbody Fusion (PLIF), with or without the use of an interbody spacer, at 1 to 3 levels between L3-S1.
Willing and able to return for the scheduled follow-up visits, follow post-operative instructions and undergo the required radiographic exams (A/P, Lateral Neutral and Lateral Flexion/Extension X-rays) for up to 4 time points between 2 weeks and 12 months post-surgery (3 months ± 2 weeks, 6±1 months, 12±2 months and if required 24±3 months post-surgery), including one CT-scan at 12±2 months.
Unresponsive to conservative care over a period of at least 6 months or has signs and/or symptoms that mandate urgent surgical intervention.
Willing and able to sign study specific informed consent.

Exclusion Criteria:

Are long term users of medications (i.e. steroids greater than 8 days) that are known to inhibit fusion or bone metabolism at any time within 6 months prior to surgery. Exceptions are inhaled steroids for asthma treatment (i.e. subjects on inhaled steroids are allowed), or epidural steroid injections.
Are taking immunosuppressive agents (Cancer chemotherapy, treatment with Disease Modifying Anti-rheumatic drugs (DMARDs) or any similar immunomodulating drugs) or are treated with Growth Factors or Insulin at any time within 6 months prior to surgery.
Are being treated with radiotherapy.
Are having medical conditions, known to impact bone metabolism, such as Paget's disease, osteoporosis, severe degenerative bone disease.
Are smokers and/or nicotine/tobacco users.
Have a Body Mass Index (BMI) ≥ 40
Are pregnant, lactating or women wishing to become pregnant.
Are a prisoner.
Are currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the study endpoints.
Prior spine surgery at the index level except posterior decompressive surgery where the posterior elements are preserved e.g. facet saving techniques such as discectomy, laminotomy, and intradiscal procedures.
Use of any other bone graft or bone graft substitute in addition to or in place of Accell Evo3 and/or local autograft.
Use of routine prophylactic NSAIDS for 3 months post-operatively, but low dose concomitant pain medications e.g. aspirin should be continued and recorded on the Concomitant Pain Medications case report form (CRF).
Have a known sensitivity Polymyxin Sulfate B, Bacitracin, Gentamycin and/or Iodine.
Severe vascular or neurological disease.
Uncontrolled diabetes.
Uncooperative patients who will not or cannot follow postoperative instructions, including individuals who abuse drugs and/or alcohol.
Renal impairment.
Active or latent infection in or around the surgical site.
Accell Evo3 is contraindicated when there is significant vascular impairment proximal to the implantation site and when there are metabolic or systemic bone disorders that affect bone or wound healing, or when stabilization of the defect is not possible.
The use of Accell Evo3 is also contraindicated in cases where intraoperative soft tissue coverage is not planned or possible and in infected or contaminated wounds.

Name	Affiliation	Role
Philip Yuan, M.D	Memorial Orthopaedic Surgical Group	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Orthopaedic Surgical Group		Long Beach	California	90806	United States

ID	Title	Description
FG000	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).

ID	Title	Description
BG000	All Patients

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays.

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.

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

Posted

Mean

Standard Deviation

months to fusion

12 months

Spinal Levels

ID	Title	Description
OG000	All Patients	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).

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	All Patients	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.

ID	Term
D003251	Constriction, Pathologic
D055009	Spondylosis

ID	Term
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D013122	Spinal Diseases
D001847	Bone Diseases