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

This study has been completed.
Sponsor:
Information provided by:
Synthes USA HQ, Inc.
ClinicalTrials.gov Identifier:
NCT01323387
First received: March 23, 2011
Last updated: July 1, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention
Lumbar Degenerative Disc Disease
Device: Interbody Fusion

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lumbar Degenerative Disc Disease Treated With

Further study details as provided by Synthes USA HQ, Inc.:

Primary Outcome Measures:
  • Radiographic fusion [ Time Frame: Up to 24 Months ] [ Designated as safety issue: No ]
    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:
  • Quality of Life using the SF-12 Scale [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ] [ Designated as safety issue: No ]
  • Functional improvement using the Oswestry Disability Index [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Enrollment: 150
Study Start Date: April 2004
Study Completion Date: February 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Treatment
Interbody fusions with Anterior Plating
Device: Interbody Fusion
allograft spacer + anterior plate
Other Names:
  • ATB
  • Anterior Tension Band

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01323387

Sponsors and Collaborators
Synthes USA HQ, Inc.
Investigators
Principal Investigator: Kirkham Wood, MD Mass. General Hospital
  More Information

No publications provided

Responsible Party: Damon Lees, Clinical Regulatory Manager, Spine Global Regulatory & Clinical Affairs, Synthes USA HQ. Inc.
ClinicalTrials.gov Identifier: NCT01323387     History of Changes
Other Study ID Numbers: 1255
Study First Received: March 23, 2011
Last Updated: July 1, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 26, 2014