Back to resultsLumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer (ATB)
Primary Purpose
Lumbar Degenerative Disc Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Interbody Fusion
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Degenerative Disc Disease
Eligibility Criteria
Inclusion Criteria:
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
- Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
- Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
- Skeletally mature and at least 18 years of age
- Signs the approved Informed Consent Document
- Is available for long term follow-up and interval visits
Exclusion Criteria:
- Has more than 2 levels to be instrumented
- Has had a previous fusion attempt at the involved level(s)
- Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
- Currently implanted with anterior instrumentation at the involved level(s)
- Patient would be classified as morbidly obese BMI > 35
- Active localized or systemic infection
- 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.)
- Has an immunosuppressive disorder
- Pregnant or interested in becoming pregnant during the study.
- Has a known sensitivity to device materials
- Mentally incompetent or prisoner
- Currently a participant in another study for the same indications.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Treatment
Arm Description
Interbody fusions with Anterior Plating
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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)
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
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.
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.
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01323387
Brief Title
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Acronym
ATB
Official Title
Lumbar Degenerative Disc Disease Treated With
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2004 (Actual)
Primary Completion Date
May 1, 2009 (Actual)
Study Completion Date
February 1, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synthes USA HQ, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Degenerative Disc Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Other
Arm Description
Interbody fusions with Anterior Plating
Intervention Type
Device
Intervention Name(s)
Interbody Fusion
Other Intervention Name(s)
ATB, Anterior Tension Band
Intervention Description
allograft spacer + anterior plate
Primary Outcome Measure Information:
Title
Number of Subjects With Successful Radiographic Fusion
Description
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
Secondary Outcome Measure Information:
Title
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.
Description
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
Title
Pain Scores on the Numeric Rating Scale (NRS)
Description
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
Title
Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
Description
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
Title
Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
Description
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
Title
SF-12 Physical Composite Score (PCS) Summary
Description
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
Title
SF-12 Mental Composite Score (MCS) Summary
Description
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
Title
Oswestry Disability Index (ODI) Summary
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Has experienced pain, functional deficit and/or neurological deficit for a minimum six month period of time prior to enrollment
Has failed to respond to non-operative treatment modalities for a minimum three month period of time prior to enrollment
Skeletally mature and at least 18 years of age
Signs the approved Informed Consent Document
Is available for long term follow-up and interval visits
Exclusion Criteria:
Has more than 2 levels to be instrumented
Has had a previous fusion attempt at the involved level(s)
Has had more than two previous open, lumbar spine surgical procedures at the involved level(s)
Currently implanted with anterior instrumentation at the involved level(s)
Patient would be classified as morbidly obese BMI > 35
Active localized or systemic infection
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.)
Has an immunosuppressive disorder
Pregnant or interested in becoming pregnant during the study.
Has a known sensitivity to device materials
Mentally incompetent or prisoner
Currently a participant in another study for the same indications.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirkham Wood, MD
Organizational Affiliation
Mass. General Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
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