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Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery | Clinical Trials | Clareo Health

COMPLETEDNA

Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

A Multi-Center, Prospective, Randomized, Controlled Clinical Trial Comparing the Safety and Effectiveness of ProDisc to Spinal Fusion Surgery in the Treatment of Discogenic Pain Associated With DDD in the Lumbosacral Spine

NCT00295009•Synthes USA HQ, Inc.

View on ClinicalTrials.gov

Summary

The objective of this clinical investigation is to compare the safety and effectiveness of ProDisc total disc replacement to spinal fusion surgery in the treatment of discogenic pain associated with DDD in the lumbosacral spine. There will be separate study arms for one and two level cases.

Eligibility

Age

18 - 60 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Degenerative Disc Disease (DDD) in one or two adjacent vertebral levels between L3 and S1. Diagnosis of DDD requires: a)Back and/or leg (radicular) pain; and b)Radiographic confirmation of any 1 of the following by CT, MRI, discography, plain film, myelography and/or flexion/extension films: Instability (greater than or equal to 3mm translation or 5° angulation); Decreased disc height \>2mm; Scarring/thickening of annulus fibrosis; Herniated nucleus pulposus; or Vacuum phenomenon.
•Age between 18 and 60 years.
•Failed at least 6 months of conservative treatment.
•Oswestry Low Back Pain Disability Questionnaire score of at least 20/50 (40%)(Interpreted as moderate/severe disability).
•Psychosocially, mentally and physically able to fully comply with this protocol including adhering to follow-up schedule and requirements and filling out forms.
•Signed informed consent.

Exclusion Criteria

•No more than 2 vertebral levels may have DDD and all diseased levels, either one or two, must be treated.
•Patients with involved vertebral endplates dimensionally smaller than 34.5mm in the medial-lateral and/or 27mm in the anterior-posterior directions.
•Known allergy to titanium, polyethylene, cobalt, chromium, or molybdenum.
•Prior fusion surgery at any vertebral level.
•Clinically compromised vertebral bodies at the affected level(s) due to current or past trauma.
•Radiographic confirmation of facet joint disease or degeneration.
•Lytic spondylolisthesis or spinal stenosis.
•Degenerative spondylolisthesis of grade \>1.
•Back or leg pain of unknown etiology.
•Osteopenia or Osteoporosis: A screening questionnaire for osteoporosis, SCORE (Simple Calculated Osteoporosis Risk Estimation), will be used to screen patients to determine if a DEXA scan is required. If DEXA is required, exclusion will be defined as a DEXA bone density measured T score less than
+9 more criteria

Key Dates

Start Date

September 1, 2001

Primary Completion Date

April 1, 2011

Completion Date

April 1, 2011

Last Updated

August 6, 2014

Enrollment

852

ACTUAL participants

Conditions

Spinal Diseases

Interventions

ProDisc

DEVICE

Spinal Fusion

PROCEDURE

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Spine DiseaseSpinal Diseases

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 6, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

Inclusion Criteria

Exclusion Criteria

Comparison of Perineural Dexamethasone Versus Dexmedetomidine as Adjuvants to Erector Spinae Plane Block in Lumbar Spine Surgery: A Randomized, Double-blind, Controlled Trial

Prevention of Thromboembolism Using Apixaban vs Enoxaparin Following Spinal Cord Injury

Comparing 3D and 2D Views in Biportal Spine Surgery: A Pilot Simulation Study

Intra-arterial Chemotherapy for Spinal Metastases

Effect of Neuromuscular Blockade on Operating Conditions and Overall Satisfaction During Spinal Surgery

The Effect of Perioperative Lidocaine Intravenous Infusion on Postoperative Recovery After Spine Surgery.