Clinical trial NCT00759057: A Clinical Study of the Dynesys(R) Spinal System
Official title: A Clinical Study of the Dynesys(R) Spinal System As a Non-fusion Device for Spinal Stabilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Degenerative Spondylolisthesis or Retrolisthesis
Spinal Stenosis
Stenosing Lesion.
Keywords: Spinal Stenosis
Spinal Instability
Leg Pain
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 399
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Clinical Success (VAS Leg Pain, ODI, Major Complications, Additional Surgical Procedures, Neurological Status)
timeFrame: 24 Months
Secondary outcomes:
measure: Radiographic Success, SF-12, Back Pain, Economic and Function Assessment, Subject Perception
timeFrame: 24 Months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Scottsdale Spine Center
state: Arizona
city: Tucson
country: United States
facility: Northwest NeuroSpecialists
state: Arizona
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center, The Spine Institute
state: California
city: Modesto
country: United States
facility: Pacific Regional Neurosurgery
state: California
city: Denver
country: United States
facility: Denver Spine Center
state: Colorado
city: Washington
country: United States
facility: Medical Faculty Associates - The George Washington University
state: District of Columbia
city: Aventura
country: United States
facility: Orthopedic Care & Sports Medicine Center
state: Florida
city: Atlanta
country: United States
facility: Peachtree Orthopaedic Clinic
state: Georgia
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopedic
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Neurosurgical
state: Indiana
city: Overland Park
country: United States
facility: Heartland Spine and Hand Center
state: Kansas
city: Baton Rouge
country: United States
facility: Spine Specialty Center (SSC)
state: Louisiana
city: Baltimore
country: United States
facility: Baltimore Neurosurgical Associates, PA
state: Maryland
city: Towson
country: United States
facility: Orthopaedic Associates
state: Maryland
city: Peabody
country: United States
facility: Sports Medicine North
state: Massachusetts
city: Edina
country: United States
facility: Orthopedic Consultants, PA
state: Minnesota
city: New York
country: United States
facility: Manhattan Orthopaedics, PC
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University Dept of Orthopedic Surgery
state: New York
city: Durham
country: United States
facility: Triangle Orthopedic Associates
state: North Carolina
city: Eugene
country: United States
facility: Orthopaedic Spine Associates
state: Oregon
city: Pittsburgh
country: United States
facility: Dept. of Neurosurgery UPMC Presbyterian
state: Pennsylvania
city: Willow Grove
country: United States
facility: Abington Hospital
state: Pennsylvania
city: Mt. Pleasant
country: United States
facility: SPINE
state: South Carolina
city: College Station
country: United States
facility: College Station Neurosurgery
state: Texas
city: Houston
country: United States
facility: Park Plaza Hospital
state: Texas
city: Plano
country: United States
facility: SpineMark CRO at TBI
state: Texas
Study officials:
References: