Lumbar Degenerative Disc Disease Treated With

Synthes USA HQ, Inc.0 sites178 target enrollmentApril 1, 2004

ConditionsLumbar Degenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lumbar Degenerative Disc Disease
Sponsor: Synthes USA HQ, Inc.
Enrollment: 178
Primary Endpoint: Number of Subjects With Successful Radiographic Fusion
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

April 1, 2004

End Date

February 1, 2011

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Synthes USA HQ, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•One or Two level (consecutive) degenerative disc disease between L2 and S
•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

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

Outcomes

Primary Outcomes

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

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)
SF-12 Mental Composite Score (MCS) Summary(Baseline and 24 Months)
Oswestry Disability Index (ODI) Summary(Baseline and 24 Months)