Clinical trial NCT01323387: Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Official title: Lumbar Degenerative Disc Disease Treated With
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lumbar Degenerative Disc Disease
Lead sponsor: Synthes USA HQ, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-25
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Subjects With Successful Radiographic Fusion
timeFrame: 24 Months
Secondary outcomes:
measure: 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.
timeFrame: 24 Months
measure: Pain Scores on the Numeric Rating Scale (NRS)
timeFrame: Baseline and 24 Months
measure: Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline
timeFrame: 24 Months
measure: Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline
timeFrame: Baseline and 24 Months
measure: SF-12 Physical Composite Score (PCS) Summary
timeFrame: Baseline and 24 Months
measure: SF-12 Mental Composite Score (MCS) Summary
timeFrame: Baseline and 24 Months
measure: Oswestry Disability Index (ODI) Summary
timeFrame: Baseline and 24 Months
Other outcomes:
Locations:
Study officials:
affiliation: Mass. General Hospital
name: Kirkham Wood, MD
role: PRINCIPAL_INVESTIGATOR
References: