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

NCT ID: NCT01323387

Last Updated: 2018-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-01
• Study Completion Date: 2011-02-01

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.

Conditions

Lumbar Degenerative Disc Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

Interbody fusions with Anterior Plating

Group Type: OTHER

Interbody Fusion

Intervention Type: DEVICE

allograft spacer + anterior plate

Interventions

Interbody Fusion

allograft spacer + anterior plate

Intervention Type: DEVICE

Other Intervention Names

ATB; Anterior Tension Band

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Synthes USA HQ, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirkham Wood, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Other Identifiers

1255

Identifier Type: -

Identifier Source: org_study_id