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

• ClinicalTrials.gov Identifier: NCT01323387
• Recruitment Status: Completed
• First Posted: March 25, 2011
• Results First Posted: May 17, 2017
• Last Update Posted: January 16, 2018
• Sponsor: Synthes USA HQ, Inc.
• Information provided by (Responsible Party): Synthes USA HQ, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Lumbar Degenerative Disc Disease	Device: Interbody Fusion	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 178 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Lumbar Degenerative Disc Disease Treated With
• Actual Study Start Date: April 1, 2004
• Actual Primary Completion Date: May 1, 2009
• Actual Study Completion Date: February 1, 2011

Arms and Interventions

Arm	Intervention/treatment
Treatment; Interbody fusions with Anterior Plating	Device: Interbody Fusion; allograft spacer + anterior plate; Other Names: ATB; Anterior Tension Band

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Sponsors and Collaborators

Synthes USA HQ, Inc.

Investigators

• Principal Investigator: Kirkham Wood, MD; Mass. General Hospital

More Information

• Responsible Party: Synthes USA HQ, Inc.
• ClinicalTrials.gov Identifier: NCT01323387
• Other Study ID Numbers: 1255
• First Posted: March 25, 2011
• Results First Posted: May 17, 2017
• Last Update Posted: January 16, 2018
• Last Verified: December 2017

Additional relevant MeSH terms:

Spinal Diseases; Intervertebral Disc Degeneration; Bone Diseases; Musculoskeletal Diseases