Safety and Effectiveness Study of Prodisc to Spinal Fusion Surgery

NCT00295009 | Completed Results

• 1 other identifier: PDL-07272001
• Study Type: interventional
• Target: 852
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Spinal Diseases

Outcome Measures

Primary Outcomes (2)

• Overall Success

  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

  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

Study Arms (6)

1-Level Fusion

ACTIVE COMPARATOR

Spinal fusion at a single lumbar level.

Procedure: Spinal Fusion

1-Level ProDisc

EXPERIMENTAL

Total disc replacement with the ProDisc device at one spinal lumbar level.

Device: ProDisc

2-Level Fusion

ACTIVE COMPARATOR

Spinal fusion at two adjacent lumbar levels.

Procedure: Spinal Fusion

2-Level ProDisc

EXPERIMENTAL

Total disc replacement with the ProDisc device at two adjacent lumbar levels.

Device: ProDisc

1-level ProDisc (non-randomized)

EXPERIMENTAL

Total disc replacement with the ProDisc device for non-randomized subjects at one spinal lumbar level.

Device: ProDisc

2-Level ProDisc (Continued Access)

ACTIVE COMPARATOR

Total disc replacement with the ProDisc device for non-randomized subjects at two spinal lumbar levels (only followed out to 24 months)

Device: ProDisc

Interventions

ProDisc DEVICE

Total disc replacement with ProDisc

1-Level ProDisc; 1-level ProDisc (non-randomized); 2-Level ProDisc; 2-Level ProDisc (Continued Access)

Spinal Fusion PROCEDURE

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.

1-Level Fusion; 2-Level Fusion

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Synthes USA HQ, Inc.: lead

Related Publications (1)

• Zigler JE, Glenn J, Delamarter RB. Five-year adjacent-level degenerative changes in patients with single-level disease treated using lumbar total disc replacement with ProDisc-L versus circumferential fusion. J Neurosurg Spine. 2012 Dec;17(6):504-11. doi: 10.3171/2012.9.SPINE11717. Epub 2012 Oct 19.

  PMID: 23082849 DERIVED

MeSH Terms

Conditions

Spinal Diseases

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Arthrodesis; Orthopedic Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Erin Prifogle
• Organization: DePuy Synthes

eprifog1@its.jnj.com

508-977-6451

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 20, 2006
• First Posted: February 22, 2006
• Study Start: September 1, 2001
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 6, 2014
• Results First Posted: August 1, 2014

Record last verified: 2014-07