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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Lumbar Degenerative Disc Disease Treated With

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.


Detailed Summary:
Sponsor: Synthes USA HQ, Inc.

Current Primary Outcome: Number of Participants With Successful Radiographic Fusion [ Time Frame: 24 Months ]

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.


Original Primary Outcome: Radiographic fusion [ Time Frame: 24 Months Post-op ]

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.


Current Secondary Outcome:

  • Quality of Life Using the SF-12 Scale (PCS)- Number of Subjects That Achieved 15% Improvement in PCS Compared to Baseline. [ Time Frame: 24 months ]
    The outcome measure is the number of subjects that achieved a 15% improvement in the Physical Health Component Score (PCS) compared to baseline. The PCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.
  • Pain Scores on the Numeric Rating Scale (NRS) [ Time Frame: 24 months ]
    The Numeric Rating Scale (NRS) is a measurement of Pain from a value of 0 (no pain) to a value of 10 (Worst Pain).
  • Oswestry Disability Index: Number of Subjects That Achieved a 15% Improvement in ODI Compared to Baseline [ Time Frame: 24 months ]

    The outcome measure is the number of subjects that achieved a 15% improvement in ODI compared to baseline.

    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

    The range is 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.

  • Quality of Life Using SF-12 Scale (MCS): Number of Subjects That Achieved 15% Improvement in MCS Compared to Baseline. [ Time Frame: up to 24 months ]
    The outcome measure is the number of subjects that achieved a 15% improvement in MCS compared to baseline. The MCS (Mental Component Score) is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.
  • SF-12 Physical Component Summary [ Time Frame: 24 months ]
    The Physical Component Summary of the SF-12 is a self-reported quality of life assessment to measure a participant's interpretation of their physical well-being. The PCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.
  • SF-12 Mental Component Summary [ Time Frame: 24 months ]
    The Mental Component Summary of the SF-12 is a self-reported quality of life assessment to measure a participant's interpretation of their mental well-being. The MCS is a measurement of health status, with a range of 0-100. A Higher score indicates less disability.
  • Oswestry Disability Index (ODI) [ Time Frame: 24 months ]

    The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain.

    The range is 0 to 100. Zero is equated with no disability and 100 is the maximum disability possible.



Original Secondary Outcome:

  • Quality of Life using the SF-12 Scale [ Time Frame: up to 24 months ]
  • Pain Scores on the Visual Analog Scale [ Time Frame: Up to 24 months ]
  • Functional improvement using the Oswestry Disability Index [ Time Frame: up to 24 months ]


Information By: Synthes USA HQ, Inc.

Dates:
Date Received: March 23, 2011
Date Started: April 2004
Date Completion:
Last Updated: April 14, 2017
Last Verified: April 2017