A Clinical Study of the Dynesys(R) Spinal System

A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization

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.

Study Overview

• Status: Terminated
• Conditions: Spinal Stenosis; Degenerative Spondylolisthesis or Retrolisthesis; Stenosing Lesion.
• Intervention / Treatment: Device: Posterior Pedicle Screw System

Detailed Description

The purpose of this clinical study is to demonstrate the safety and effectiveness of the Dynesys Spinal System for patients requiring one or contiguous two-level posterior spinal stabilization of the lumbar, and/or sacral spine following decompression. The ability for this implant to maintain spinal alignment and non-fusion of spinal segments, while positively affecting clinical outcomes, will be assessed and compared to a posterior lateral spinal fusion (PLF) procedure using autogenous bone with a semi-rigid, polyaxial posterior spinal fixation system.

• Study Type: Interventional
• Enrollment (Actual): 399
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85251
      • Scottsdale Spine Center
    • Tucson, Arizona, United States, 85741
      • Northwest NeuroSpecialists
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center, The Spine Institute
    • Modesto, California, United States, 95350
      • Pacific Regional Neurosurgery
  • Colorado
    • Denver, Colorado, United States, 80218
      • Denver Spine Center
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • Medical Faculty Associates - The George Washington University
  • Florida
    • Aventura, Florida, United States, 33180
      • Orthopedic Care & Sports Medicine Center
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Peachtree Orthopaedic Clinic
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Orthopedic
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Neurosurgical
  • Kansas
    • Overland Park, Kansas, United States, 66211
      • Heartland Spine and Hand Center
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70810
      • Spine Specialty Center (SSC)
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Baltimore Neurosurgical Associates, PA
    • Towson, Maryland, United States, 21204
      • Orthopaedic Associates
  • Massachusetts
    • Peabody, Massachusetts, United States, 01960
      • Sports Medicine North
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Orthopedic Consultants, PA
  • New York
    • New York, New York, United States, 10021
      • Manhattan Orthopaedics, PC
    • Syracuse, New York, United States, 13202
      • SUNY Upstate Medical University Dept of Orthopedic Surgery
  • North Carolina
    • Durham, North Carolina, United States, 27704
      • Triangle Orthopedic Associates
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Orthopaedic Spine Associates
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213-2582
      • Dept. of Neurosurgery UPMC Presbyterian
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Hospital
  • South Carolina
    • Mt. Pleasant, South Carolina, United States, 29464
      • SPINE
  • Texas
    • College Station, Texas, United States, 77845
      • College Station Neurosurgery
    • Houston, Texas, United States, 77004
      • Park Plaza Hospital
    • Plano, Texas, United States, 75093
      • SpineMark CRO at TBI

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;
• Pregnancy;
• Incarceration;
• Severe muscular, neural or vascular diseases that endanger the spinal column;
• Missing bone structures, due to severely deformed anatomy or congenital anomalies, which make good anchorage of the implant impossible;
• All concomitant diseases that can jeopardize the functioning and success of the patient;
• Vertebral fractures;
• Treatment of the thoracic and cervical spine;
• Severely deformed anatomy due to congenital anomalies;
• Paralysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1 - Investigational; Dynesys Non-Fusion Spinal System	Device: Posterior Pedicle Screw System; Implantation of Posterior Pedicle Screw System
ACTIVE_COMPARATOR: 2 - Control; Silhouette Posterior Pedicle Screw System as an adjunct to Posterior Lateral Fusion with Autograft.	Device: Posterior Pedicle Screw System; Implantation of Posterior Pedicle Screw System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)	24 Months

Secondary Outcome Measures

Outcome Measure	Time Frame
Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception	24 Months

Collaborators and Investigators

• Sponsor: Zimmer Biomet

Study record dates

Study Major Dates

• Study Start: March 1, 2003
• Primary Completion (ANTICIPATED): June 1, 2015
• Study Completion (ANTICIPATED): December 1, 2015

Study Registration Dates

• First Submitted: September 23, 2008
• First Submitted That Met QC Criteria: September 23, 2008
• First Posted (ESTIMATE): September 25, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): June 28, 2012
• Last Update Submitted That Met QC Criteria: June 26, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Spinal Stenosis; Leg Pain; Spinal Instability
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Spondylosis; Spinal Stenosis; Spondylolisthesis
• Other Study ID Numbers: G020291