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

NCT01323387 | Completed Results

• 1 other identifier: 1255
• Study Type: interventional
• Target: 178
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Successful Radiographic Fusion

  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.

  24 Months

Secondary Outcomes (7)

• 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.

  24 Months

• Pain Scores on the Numeric Rating Scale (NRS)

  Baseline and 24 Months

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

  24 Months

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

  Baseline and 24 Months

• SF-12 Physical Composite Score (PCS) Summary

  Baseline and 24 Months

Study Arms (1)

Treatment

OTHER

Interbody fusions with Anterior Plating

Device: Interbody Fusion

Interventions

Interbody Fusion DEVICE

allograft spacer + anterior plate

Also known as: ATB, Anterior Tension Band

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Clinical Research Associate
• Organization: Synthes Spine

knappk@synthes.com

610-719-5942

Study Officials

• Kirkham Wood, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 25, 2011
• Study Start: April 1, 2004
• Primary Completion: May 1, 2009
• Study Completion: February 1, 2011
• Last Updated: January 16, 2018
• Results First Posted: May 17, 2017

Record last verified: 2017-12