N/A
N=178
Lumbar Degenerative Disc Disease Treated With Anterior Tension Band System (ATB) With ALIF/FRA Spacer
Lumbar Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT01323387 ↗Enrolled (actual)
178
Serious AEs
12.7%
Results posted
May 2017
Primary outcome: Primary: Number of Subjects With Successful Radiographic Fusion — 90 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Interbody Fusion (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synthes USA HQ, Inc.
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Successful Radiographic Fusion |
90 | — |
| 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. |
57 | — |
| SECONDARY Pain Scores on the Numeric Rating Scale (NRS) |
8.0; 4.6 | — |
| SECONDARY Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline |
63 | — |
| SECONDARY Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline |
42 | — |
| SECONDARY SF-12 Physical Composite Score (PCS) Summary |
29.4; 38.9 | — |
| SECONDARY SF-12 Mental Composite Score (MCS) Summary |
38.2; 45.6 | — |
| SECONDARY Oswestry Disability Index (ODI) Summary |
53.3; 31.8 | — |
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
- 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.
Data sourced from ClinicalTrials.gov (NCT01323387). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.