Accell Evo3™ Demineralized Bone Matrix in Instrumented Lumbar Spine Fusion
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|ClinicalTrials.gov Identifier: NCT02018445|
Recruitment Status : Completed
First Posted : December 23, 2013
Results First Posted : February 18, 2020
Last Update Posted : February 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Degenerative Changes Stenosis Spondylosis||Procedure: Posterolateral Fusion||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||May 2017|
Accell Evo3 DBM & Local Autograft
Accell Evo3 DBM (posterolateral gutter symptomatic side) and Local Autograft (posterolateral gutter contralateral non-symptomatic side)
Procedure: Posterolateral Fusion
- Time to Arthrodesis (Fusion) for Each Spinal Level (Unit), as Measured by X-rays. [ Time Frame: 12 months ]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.
- Percent (%) of Fusion for Each Spinal Level (Unit), as Measured by Computed Tomography (CT) Scan [ Time Frame: 12 months ]
- Medical Outcomes: Oswestry Disability Index (ODI) [ Time Frame: 12 months ]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.
- Medical Outcomes: Worst Leg Pain Visual Analog Scale (VAS) [ Time Frame: 12 months ]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.
- Medical Outcomes: Back Pain Visual Analog Scale (VAS) [ Time Frame: 12 months ]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.
- Medical Outcomes: Measure of EQ-5D™ Visual Analog Scale (VAS). [ Time Frame: 12 months ]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.
- Medical Outcomes: Maintenance of Lower Extremity Neurological Function [ Time Frame: 12 months ]
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.
- Number of Patients With Serious Adverse Events, Adverse Device Effects, Serious Adverse Device Effects and Subsequent Surgical Interventions [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02018445
|United States, California|
|Memorial Orthopaedic Surgical Group|
|Long Beach, California, United States, 90806|
|Principal Investigator:||Philip Yuan, M.D||Memorial Orthopaedic Surgical Group|