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

DePuy Synthes

Status: Completed

Conditions: Lumbar Degenerative Disc Disease

Treatments: Device: Interbody Fusion

Study type: Interventional

Funder types: Industry

Identifiers

NCT01323387

1255

Details and patient eligibility

About

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.

Enrollment: 178 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Treatment

Other group

Description:

Interbody fusions with Anterior Plating

Treatment:

Device: Interbody Fusion