Lumbar Degenerative Disc Disease
Conditions
Brief summary
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.
Interventions
DEVICEInterbody Fusion
allograft spacer + anterior plate
Sponsors
Synthes USA HQ, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. One or Two level (consecutive) degenerative disc disease between L2 and S1. Degenerative disc disease is defined as follows: Chronic pain (confirmed by patient exams and history) of discogenic origin, confirmed by radiographic evidence (e.g. MRI, discogram) two or more of the following: * Modic type 2 endplate changes on T2 weighted MRI * high intensity zone signal on T2 weighted MRI * positive discogram with negative controls * dark disc (diminished T2 weighted signal) * decreased disc height 2. Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment 3. Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment 4. Skeletally mature and at least 18 years of age 5. Signs the approved Informed Consent Document 6. Is available for long term follow-up and interval visits
Exclusion criteria
1. Has more than 2 levels to be instrumented 2. Has had a previous fusion attempt at the involved level(s) 3. Has had more than two previous open, lumbar spine surgical procedures at the involved level(s) 4. Currently implanted with anterior instrumentation at the involved level(s) 5. Patient would be classified as morbidly obese BMI \> 35 6. Active localized or systemic infection 7. Presence of a disease entity or condition which significantly affects the possibility of bony fusion (e.g., osteoporosis, metastatic cancer, long-term use of steroids, etc.) 8. Has an immunosuppressive disorder 9. Pregnant or interested in becoming pregnant during the study. 10. Has a known sensitivity to device materials 11. Mentally incompetent or prisoner 12. Currently a participant in another study for the same indications.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Successful Radiographic Fusion | 24 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores on the Numeric Rating Scale (NRS) | Baseline and 24 Months | The Numeric Rating Scale (NRS) is a measurement of pain from a value of 0 (no pain) to a value of 10 (worst pain) |
| Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline | 24 Months | 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 |
| Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline | Baseline and 24 Months | 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. |
| 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. | 24 Months | 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. |
| SF-12 Mental Composite Score (MCS) Summary | Baseline and 24 Months | The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. |
| Oswestry Disability Index (ODI) Summary | Baseline and 24 Months | 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 |
| SF-12 Physical Composite Score (PCS) Summary | Baseline and 24 Months | The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Interbody fusions with Anterior Plating | 150 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 12 |
| Overall Study | Radiographic Data Unavailable | 1 |
| Overall Study | Randomized but Never Treated | 16 |
| Overall Study | Revision | 14 |
| Overall Study | Withdrawal by Subject | 41 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants |
| Age, Continuous | 43.6 years STANDARD_DEVIATION 9.29 |
| Region of Enrollment United States | 150 participants |
| Sex: Female, Male Female | 77 Participants |
| Sex: Female, Male Male | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 77 / 150 |
| serious Total, serious adverse events | 19 / 150 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Number of Subjects With Successful Radiographic Fusion | 90 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline | 63 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Oswestry Disability Index (ODI) Summary | ODI at Baseline | 53.3 Units on a scale | Standard Deviation 13.7 |
| Treatment | Oswestry Disability Index (ODI) Summary | ODI at 24 Months | 31.8 Units on a scale | Standard Deviation 23 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | Pain Scores on the Numeric Rating Scale (NRS) | NRS at Baseline | 8.0 units on a scale | Standard Deviation 1.7 |
| Treatment | Pain Scores on the Numeric Rating Scale (NRS) | NRS at 24 Months | 4.6 units on a scale | Standard Deviation 3 |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline | 42 Participants |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment | 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. | 57 Participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | SF-12 Mental Composite Score (MCS) Summary | MCS at Baseline | 38.2 Units on a scale | Standard Deviation 11.7 |
| Treatment | SF-12 Mental Composite Score (MCS) Summary | MCS at 24 Months | 45.6 Units on a scale | Standard Deviation 14 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment | SF-12 Physical Composite Score (PCS) Summary | PCS at Baseline | 29.4 Units on a scale | Standard Deviation 7 |
| Treatment | SF-12 Physical Composite Score (PCS) Summary | PCS at 24 Months | 38.9 Units on a scale | Standard Deviation 13.5 |