Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer (ATB)

Lumbar Degenerative Disc Disease Treated With

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 Overview

• Status: Completed
• Conditions: Lumbar Degenerative Disc Disease
• Intervention / Treatment: Device: Interbody Fusion

• Study Type: Interventional
• Enrollment (Actual): 178
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Treatment; Interbody fusions with Anterior Plating	Device: Interbody Fusion; allograft spacer + anterior plate; Other Names: ATB; Anterior Tension Band

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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)	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	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.	Baseline and 24 Months
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.	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.	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	Baseline and 24 Months

Collaborators and Investigators

• Sponsor: Synthes USA HQ, Inc.
• Investigators: Principal Investigator: Kirkham Wood, MD, Mass. General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2004
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: March 23, 2011
• First Submitted That Met QC Criteria: March 24, 2011
• First Posted (Estimate): March 25, 2011

Study Record Updates

• Last Update Posted (Actual): January 16, 2018
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Intervertebral Disc Degeneration; Spinal Diseases
• Other Study ID Numbers: 1255