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Completed

NCT Number: NCT01323387

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

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.

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Key information

Conditions

Lumbar Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Interbody Fusion

Device

allograft spacer + anterior plate

Other names: ATB, Anterior Tension Band

Primary outcomes

  1. Number of Subjects 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.

Secondary outcomes

  1. 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.

    Time frame: 24 Months

    Quality of Life using the SF-12 Scale Physical Health Component Score (PCS). The PCS is a measurement of health status with a range of 0-100. A higher score indicates less disability.

  2. Pain Scores on the Numeric Rating Scale (NRS)

    Time frame: Baseline and 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)

  3. Oswestry Disability Index (ODI): Number of Subjects Who Achieved a 15% Improvement in ODI Compared to Baseline

    Time frame: 24 Months

    The outcome measure is the number of subjects who achieved a 15% improvement in ODI compared to baseline. The ODI is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. ODI scores range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible

  4. Quality of Life Using SF-12 Scale (MCS): Number of Subjects Who Achieved 15% Improvement in MCS Compared to Baseline

    Time frame: Baseline and 24 Months

    The outcome measure is the number of subjects who 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 to 100. A higher score indicates less disability.

  5. SF-12 Physical Composite Score (PCS) Summary

    Time frame: Baseline and 24 Months

    The PCS (Physical Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.

  6. SF-12 Mental Composite Score (MCS) Summary

    Time frame: Baseline and 24 Months

    The MCS (Mental Component Score) is a measurement of health status with a range of 0 to 100. A higher score indicates less disability.

  7. Oswestry Disability Index (ODI) Summary

    Time frame: Baseline and 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 scores can range from 0 to 100 with 0 equating to No Disability and 100 equating to the Maximum Disability Possible

Sponsors and collaborators

Lead sponsor

Synthes USA HQ, Inc.

Industry

Registry information

Official study title

Lumbar Degenerative Disc Disease Treated With

Acronym: ATB

Important dates

Study start
2004
Primary completion
2009
Study completion
2011
First posted
Mar 25, 2011
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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