Clinical trial NCT00437190: Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
Official title: Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy
Myelopathy
Cervical Degenerative Disc Disease
Keywords: Cervical Disc Replacement
Spondylotic radiculopathy
Spondylotic myelopathy
Myelopathy
Radiculopathy
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2007-02-19
Enrollment: 494
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Detailed description: Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

Eligibility criteria: Inclusion Criteria:

The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

The following additional inclusion criteria had to be present:

* At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
* Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
* Skeletally mature (≥ 21 years of age);
* Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
* Willing to sign informed consent and comply with protocol.

Exclusion Criteria:

Subjects were excluded if they had any of the following:

* Any of the following at the treated level:

  * Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
  * Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
  * Radiographic signs of subluxation greater than 3.5 mm;
  * Angulation of the disc space more than 11 degrees greater than adjacent segments;
  * Significant kyphotic deformity or significant reversal of lordosis;
* Axial neck pain as the solitary symptom;
* Previous cervical spine surgery;
* Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
* Active systemic infection or infection at the operative site;
* Known allergy or to titanium, polyurethane, or ethylene oxide residuals;
* Concomitant conditions requiring steroid treatment;
* Diabetes mellitus requiring daily insulin management;
* Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index;
* A medical condition that may interfere with the postoperative management program, such as advanced emphysema or Alzheimer's disease;
* A medical condition that may result in patient death prior to study completion: unstable cardiac disease, active malignancy;
* Pregnant;
* Current or recent alcohol and/or drug abuser requiring intervention;
* Signs of being geographically unstable, such as recent or pending divorce, or high level of job dissatisfaction.

Primary outcomes:
measure: Improvement in patient pain and ability to function
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurosurgical Associates
state: Arizona
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
city: Campbell
country: United States
facility: Silicon Valley Spine Institute
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital
state: California
city: Walnut Creek
country: United States
facility: Bay Area Spine Institute
state: California
city: Gainesville
country: United States
facility: North Florida Regional Medical Center
state: Florida
city: Miami
country: United States
facility: University of Miami School of Medicine
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Neurological Clinic
state: Florida
city: Atlanta
country: United States
facility: Emory Orthopedics and Spine Center
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Department of Neurosurgery
state: Illinois
city: Chicago
country: United States
facility: University of Chicago Hospitals Section of Neurosurgery
state: Illinois
city: Chicago
country: United States
facility: Chicago Inst. of Neurosurgery and Neuro Research
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Indianapolis
country: United States
facility: Indiana Spine Group
state: Indiana
city: Scarborough
country: United States
facility: Neurosurgery Associates
state: Maine
city: Annapolis
country: United States
facility: Maryland Brain & Spine
state: Maryland
city: Kalamazoo
country: United States
facility: Neurosurgery of Kalamazoo
state: Michigan
city: Marquette
country: United States
facility: Marquette General Brain & Spine Center
state: Michigan
city: Edina
country: United States
facility: Cervical Spine Specialists
state: Minnesota
city: Minneapolis
country: United States
facility: Twin Cities Spine Center
state: Minnesota
city: Columbia
country: United States
facility: Columbia Orthopaedic Group
state: Missouri
city: St. Louis
country: United States
facility: Washington University Orthopedics
state: Missouri
city: Reno
country: United States
facility: Spine Nevada
state: Nevada
city: Rochester
country: United States
facility: Rochester Brain and Spine Neuro
state: New York
city: Syracuse
country: United States
facility: Upstate Orthopedics
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital
state: New York
city: Charlotte
country: United States
facility: Carolina Neurosurgery and Spine Specialists
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center
state: North Carolina
city: Toledo
country: United States
facility: Neurosurgical Network, Inc.
state: Ohio
city: Portland
country: United States
facility: Kellogg MD Brain & Spine
state: Oregon
city: Springfield
country: United States
facility: Oregon Neurosurgery
state: Oregon
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Southeastern Spine Institute
state: South Carolina
city: Nashville
country: United States
facility: Neurosurgical Associates
state: Tennessee
city: Plano
country: United States
facility: NeuroSpine Consultants, PA
state: Texas
city: Salt Lake City
country: United States
facility: Neurosurgery Associates
state: Utah
city: Madison
country: United States
facility: University of Wisconsin Medical School
state: Wisconsin
Study officials:
affiliation: Indiana Spine Group
name: Rick C Sasso, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sasso RC, Anderson PA, Riew KD, Heller JG. Results of cervical arthroplasty compared with anterior discectomy and fusion: four-year clinical outcomes in a prospective, randomized controlled trial. J Bone Joint Surg Am. 2011 Sep 21;93(18):1684-92. doi: 10.2106/JBJS.J.00476.
citation: Heller JG, Sasso RC, Papadopoulos SM, Anderson PA, Fessler RG, Hacker RJ, Coric D, Cauthen JC, Riew DK. Comparison of BRYAN cervical disc arthroplasty with anterior cervical decompression and fusion: clinical and radiographic results of a randomized, controlled, clinical trial. Spine (Phila Pa 1976). 2009 Jan 15;34(2):101-7. doi: 10.1097/BRS.0b013e31818ee263.
citation: Arnold PM, Anderson KK, Selim A, Dryer RF, Kenneth Burkus J. Heterotopic ossification following single-level anterior cervical discectomy and fusion: results from the prospective, multicenter, historically controlled trial comparing allograft to an optimized dose of rhBMP-2. J Neurosurg Spine. 2016 Sep;25(3):292-302. doi: 10.3171/2016.1.SPINE15798. Epub 2016 Apr 29.