Multi-center, prospective nonrandomized study of treatment for 1 and 2 level degenerative disc disease between L2 and S1. Patients will be followed for a minimum of 2 years. The primary objective of this study to measure fusion success in patients with lumbar degenerative disc disease using the ATB and ALIF/FRA Spacer. The Secondary objective is evaluation of the patient's quality of life, pain and function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
178
allograft spacer + anterior plate
Number of Subjects With Successful Radiographic Fusion
CT Scans and plain film x-rays will be evaluated. Demonstration of bridging trabecular bone through or external to the allograft spacer will be the measure of success.
Time frame: 24 Months
Quality of Life Using the SF-12 Scale Physical Health Component Score (PCS). Number of Subjects Who Achieved 15% Improvement in PCS Compared to Baseline.
Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.
Time frame: 24 Months
Pain Scores on the Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain)
Time frame: Baseline and 24 Months
Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Time frame: 24 Months
Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
The outcome measure is the number of subjects who achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Time frame: Baseline and 24 Months
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SF-12 Physical Composite Score (PCS) Summary
The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Time frame: Baseline and 24 Months
SF-12 Mental Composite Score (MCS) Summary
The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.
Time frame: Baseline and 24 Months
Oswestry Disability Index (ODI) Summary
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. The scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible
Time frame: Baseline and 24 Months