A Clinical Study of the Dynesys(R) Spinal System

NCT00759057 | Terminated Phase 3

• 1 other identifier: G020291
• Study Type: interventional
• Target: 399
• Locations: 1 country
• Sites: 26

Brief Summary

This non-inferiority study will compare the clinical outcomes of subjects implanted with the Dynesys Spinal System versus the clinical outcomes of subjects implanted with an instrumented posterior lateral spinal fusion.

Conditions

Degenerative Spondylolisthesis or Retrolisthesis; Spinal Stenosis; Stenosing Lesion.

Keywords

Spinal Stenosis; Spinal Instability; Leg Pain

Outcome Measures

Primary Outcomes (1)

• Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)

  24 Months

Secondary Outcomes (1)

• Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception

  24 Months

Study Arms (2)

1 - Investigational

EXPERIMENTAL

Dynesys Non-Fusion Spinal System

Device: Posterior Pedicle Screw System

2 - Control

ACTIVE COMPARATOR

Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft.

Device: Posterior Pedicle Screw System

Interventions

Posterior Pedicle Screw System DEVICE

Implantation of Posterior Pedicle Screw System

1 - Investigational; 2 - Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having degenerative spondylolisthesis or retrolisthesis (up to Grade 1) AND/OR Patients having lateral or central spinal stenosis or other stenosing lesion as diagnosed by radiculopathic signs, neurogenic claudication or imaging studies;
• Candidate for single-level or contiguous two-level PLF between L1-S1;
• Patients have a predominate component of leg rather than back symptoms; symptoms include pain, muscle weakness, and/or sensation abnormality as evidenced by patient history and diagnostic studies.
• Patients may require decompression at the levels considered for treatment
• Pre-operative leg pain score greater than or equal to 40 mm on a 100 mm Visual Analog Scale (VAS);
• Leg pain must be unresponsive to conservative (non-surgical) management for minimum of 3 months;
• Pre-operative Oswestry score greater than or equal to 30 indicating at least moderate disability;
• Skeletally mature individual between ages 20 and 80;
• Must be willing and able to comply with study requirements; including willing and able to sign a study-specific, IRB-approved informed consent form, complete necessary study paperwork and return for required follow-up visits.

You may not qualify if:

• Primary diagnosis of discogenic back pain at affected levels as evidenced by a larger back than leg pain component. In the event of multi-level pathology a discogram should be considered;
• Patients with leg pain due to etiologies other than those listed above, such as trauma, peripheral vascular disease and neuropathy should be excluded;
• Degenerative scoliosis greater than 10 degrees at the affected motion segment;
• Supplemental interbody column support (e.g., bone graft, spacers or fusion cages) is planned at the affected level(s);
• Greater than Grade I spondylolisthesis or retrolisthesis at the affected level(s);
• Radiculopathic signs from more than two contiguous or two noncontiguous vertebral body segment(s);
• Previous lumbar fusion attempt(s), previous total facetectomy or trauma at the affected level(s);
• Gross obesity defined as exceeding ideal weight by greater than 40% (measurement details are given in Appendix A);
• Active local or systemic infection;
• Advanced osteoporosis as evidenced by plain film radiographs or history of fractures and confirmed by DEXA scan to confirm adequate bone density;
• Receiving immunosuppressive or long-term steroid therapy;
• Active hepatitis (viral or serum) or HIV positive, renal failure, systemic lupus erythematosus, or any other significant medical conditions which would substantially increase the risk of surgery;
• Documented history of titanium alloy, PET or PCU allergy, or intolerance;
• Active malignancy or other significant medical comorbidities;
• Current chemical dependency or significant emotional and/or psychosocial disturbance that may impact treatment outcome or study participation as evidenced by three or more positive Waddell Signs;

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (26)

Scottsdale Spine Center

Scottsdale, Arizona, 85251, United States

Location

Northwest NeuroSpecialists

Tucson, Arizona, 85741, United States

Location

Cedars-Sinai Medical Center, The Spine Institute

Los Angeles, California, 90048, United States

Location

Pacific Regional Neurosurgery

Modesto, California, 95350, United States

Location

Denver Spine Center

Denver, Colorado, 80218, United States

Location

Medical Faculty Associates - The George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Orthopedic Care & Sports Medicine Center

Aventura, Florida, 33180, United States

Location

Peachtree Orthopaedic Clinic

Atlanta, Georgia, 30342, United States

Location

Fort Wayne Orthopedic

Fort Wayne, Indiana, 46804, United States

Location

Indiana University Neurosurgical

Indianapolis, Indiana, 46202, United States

Location

Heartland Spine and Hand Center

Overland Park, Kansas, 66211, United States

Location

Spine Specialty Center (SSC)

Baton Rouge, Louisiana, 70810, United States

Location

Baltimore Neurosurgical Associates, PA

Baltimore, Maryland, 21204, United States

Location

Orthopaedic Associates

Towson, Maryland, 21204, United States

Location

Sports Medicine North

Peabody, Massachusetts, 01960, United States

Location

Orthopedic Consultants, PA

Edina, Minnesota, 55435, United States

Location

Manhattan Orthopaedics, PC

New York, New York, 10021, United States

Location

SUNY Upstate Medical University Dept of Orthopedic Surgery

Syracuse, New York, 13202, United States

Location

Triangle Orthopedic Associates

Durham, North Carolina, 27704, United States

Location

Orthopaedic Spine Associates

Eugene, Oregon, 97401, United States

Location

Dept. of Neurosurgery UPMC Presbyterian

Pittsburgh, Pennsylvania, 15213-2582, United States

Location

Abington Hospital

Willow Grove, Pennsylvania, 19090, United States

Location

SPINE

Mt. Pleasant, South Carolina, 29464, United States

Location

College Station Neurosurgery

College Station, Texas, 77845, United States

Location

Park Plaza Hospital

Houston, Texas, 77004, United States

Location

SpineMark CRO at TBI

Plano, Texas, 75093, United States

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2008
• First Posted: September 25, 2008
• Study Start: March 1, 2003
• Primary Completion: June 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 28, 2012

Record last verified: 2012-06

Locations

US (26)