A Clinical Study of the Dynesys(R) Spinal System

Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00759057
• Other study ID #: G020291
• Status: Terminated
• Phase: Phase 3
• First received: September 23, 2008
• Last updated: June 26, 2012
• Start date: March 2003
• Est. completion date: December 2015

Study information

• Verified date: June 2012
• Source: Zimmer, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 399
• Est. completion date: December 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Degenerative Spondylolisthesis or Retrolisthesis
• Spinal Stenosis
• Spondylolisthesis
• Stenosing Lesion.

Intervention

Device:
• Posterior Pedicle Screw System
Implantation of Posterior Pedicle Screw System

Locations

Country	Name	City	State
United States	Peachtree Orthopaedic Clinic	Atlanta	Georgia
United States	Orthopedic Care & Sports Medicine Center	Aventura	Florida
United States	Baltimore Neurosurgical Associates, PA	Baltimore	Maryland
United States	Spine Specialty Center (SSC)	Baton Rouge	Louisiana
United States	College Station Neurosurgery	College Station	Texas
United States	Denver Spine Center	Denver	Colorado
United States	Triangle Orthopedic Associates	Durham	North Carolina
United States	Orthopedic Consultants, PA	Edina	Minnesota
United States	Orthopaedic Spine Associates	Eugene	Oregon
United States	Fort Wayne Orthopedic	Fort Wayne	Indiana
United States	Park Plaza Hospital	Houston	Texas
United States	Indiana University Neurosurgical	Indianapolis	Indiana
United States	Cedars-Sinai Medical Center, The Spine Institute	Los Angeles	California
United States	Pacific Regional Neurosurgery	Modesto	California
United States	SPINE	Mt. Pleasant	South Carolina
United States	Manhattan Orthopaedics, PC	New York	New York
United States	Heartland Spine and Hand Center	Overland Park	Kansas
United States	Sports Medicine North	Peabody	Massachusetts
United States	Dept. of Neurosurgery UPMC Presbyterian	Pittsburgh	Pennsylvania
United States	SpineMark CRO at TBI	Plano	Texas
United States	Scottsdale Spine Center	Scottsdale	Arizona
United States	SUNY Upstate Medical University Dept of Orthopedic Surgery	Syracuse	New York
United States	Orthopaedic Associates	Towson	Maryland
United States	Northwest NeuroSpecialists	Tucson	Arizona
United States	Medical Faculty Associates - The George Washington University	Washington	District of Columbia
United States	Abington Hospital	Willow Grove	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)		24 Months	Yes
Secondary	Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception		24 Months	Yes