Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery (PDL)

July 31, 2014 updated by: Synthes USA HQ, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

852

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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
  • 1.0. The World Health Organization defines osteoporosis as a DEXA T score less than or equal to -2.5.
  • Paget's disease, osteomalacia or any other metabolic bone disease (excluding osteoporosis which is addressed above).
  • Morbid obesity defined as a body mass index >40 or a weight more than 100 lbs. over ideal body weight.
  • Pregnant or interested in becoming pregnant in the next 3 years.
  • Active infection - systemic or local.
  • Taking medication or any drug known to potentially interfere with bone/soft tissue healing (e.g., steroids).
  • Rheumatoid arthritis or other autoimmune disease.
  • Systemic disease including AIDS, HIV, Hepatitis.
  • Active malignancy: A patient with a history of any invasive malignancy (except non-melanoma skin cancer), unless he/she has been treated with curative intent and there has been no clinical signs or symptoms of the malignancy for at least 5 years.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1-Level Fusion
Spinal fusion at a single lumbar level.
Procedure: Spinal Fusion
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Experimental: 1-Level ProDisc
Total disc replacement with the ProDisc device at one spinal lumbar level.
Device: ProDisc
Total disc replacement with ProDisc
Active Comparator: 2-Level Fusion
Spinal fusion at two adjacent lumbar levels.
Procedure: Spinal Fusion
A circumferential fusion will be utilized as the control group in this study. The technique will consist of an interbody fusion procedure using commercially available femoral ring allograft. A posterior lateral fusion with autogenous iliac crest bone graft, combined with pedicle screw instrumentation.
Experimental: 2-Level ProDisc
Total disc replacement with the ProDisc device at two adjacent lumbar levels.
Device: ProDisc
Total disc replacement with ProDisc
Experimental: 1-level ProDisc (non-randomized)
Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.
Device: ProDisc
Total disc replacement with ProDisc
Active Comparator: 2-Level ProDisc (Continued Access)
Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)
Device: ProDisc
Total disc replacement with ProDisc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Success
Time Frame: 24 Months

Overall success was a composite endpoint.

A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:

  1. ODI score improved by at least 15% from baseline;
  2. SF-36 score improved from baseline;
  3. Neurologic parameters maintained or improved from baseline;
  4. No re-operations to modify or remove the implant; and
  5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.

A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:

  1. Same as above
  2. Same as above
  3. Same as above
  4. No re-operations to modify the fusion site or correct a complication with an implant; and
  5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
24 Months
Overall Success
Time Frame: 60 Months

Overall success was a composite endpoint. A ProDisc patient was considered an overall success if, and only if, ALL of the following criteria were met:

  1. ODI score improved by at least 15% from baseline;
  2. SF-36 score improved from baseline;
  3. Neurologic parameters maintained or improved from baseline;
  4. No re-operations required to modify or remove the implant; and
  5. Independent radiographic review confirmed no migration/subsidence, radiolucency, loss of disc height, loss of range of motion, or boney fusion.

A Fusion patient was a considered to be a success if, and only if, ALL of the following criteria were met:

Items numbered 1-3, above; 4. No re-operations required to modify the fusion site or correct a complication with an implant; and 5. Independent radiographic review confirmed strong evidence of fusion and no motion, visible gaps in fusion mass, loss of disc height, migration/subsidence, implant loosening, halos, or radiolucencies
60 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Synthes USA HQ, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2001

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 20, 2006

First Submitted That Met QC Criteria

February 21, 2006

First Posted (Estimate)

February 22, 2006

Study Record Updates

Last Update Posted (Estimate)

August 6, 2014

Last Update Submitted That Met QC Criteria

July 31, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDL-07272001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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