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

Not Applicable

Completed

• Conditions: Lumbar Degenerative Disc Disease
• Interventions: Device: Interbody Fusion

• Registration Number: NCT01323387
• Lead Sponsor: Synthes USA HQ, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04-01
• Primary Completion: 2009-05-01
• Study Completion: 2011-02-01
• Study First Submitted: 2011-03-23
• Study First Submitted QC: 2011-03-24
• Study First Posted: 2011-03-25
• Results First Submitted: 2016-12-06
• Results First Submitted QC: 2017-04-14
• Results First Posted: 2017-05-17
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-15
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 178

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Interbody Fusion	Interbody fusions with Anterior Plating

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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