Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

Radiculopathy Clinical Trial

Official title:

Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00437190
• Other study ID #: BRYAN(R) Cervical Disc IDE
• Status: Completed
• Phase: N/A
• First received: February 16, 2007
• Last updated: May 11, 2016
• Start date: June 2003
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: Medtronic Spinal and Biologics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 494
• Est. completion date: May 2016
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Cervical Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Myelopathy
• Radiculopathy

Intervention

Device:
• ATLANTIS™ Cervical Plate System and allograft
Control treatment is commercially available allograft (without bone matrix paste) used in conjunction with the Medtronic Safamor Danek ATLANTIS™ Cervical Plate System.
• BRYAN Cervical Disc Prosthesis
The intent is to treat stable degenerative disc disease by implanting the BRYAN Cervical Disc Prosthesis to provide motion like the normal cervical functional spinal unit.

Locations

Country	Name	City	State
United States	Maryland Brain & Spine	Annapolis	Maryland
United States	Emory Orthopedics and Spine Center	Atlanta	Georgia
United States	Silicon Valley Spine Institute	Campbell	California
United States	Carolina Neurosurgery and Spine Specialists	Charlotte	North Carolina
United States	Chicago Inst. of Neurosurgery and Neuro Research	Chicago	Illinois
United States	Northwestern University Department of Neurosurgery	Chicago	Illinois
United States	University of Chicago Hospitals Section of Neurosurgery	Chicago	Illinois
United States	Columbia Orthopaedic Group	Columbia	Missouri
United States	Cervical Spine Specialists	Edina	Minnesota
United States	North Florida Regional Medical Center	Gainesville	Florida
United States	Indiana Spine Group	Indianapolis	Indiana
United States	Indiana University School of Medicine	Indianapolis	Indiana
United States	Neurosurgery of Kalamazoo	Kalamazoo	Michigan
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	University of Wisconsin Medical School	Madison	Wisconsin
United States	Marquette General Brain & Spine Center	Marquette	Michigan
United States	University of Miami School of Medicine	Miami	Florida
United States	Twin Cities Spine Center	Minneapolis	Minnesota
United States	Southeastern Spine Institute	Mount Pleasant	South Carolina
United States	Neurosurgical Associates	Nashville	Tennessee
United States	Hoag Memorial Hospital	Newport Beach	California
United States	Barrow Neurosurgical Associates	Phoenix	Arizona
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	NeuroSpine Consultants, PA	Plano	Texas
United States	Kellogg MD Brain & Spine	Portland	Oregon
United States	Spine Nevada	Reno	Nevada
United States	Rochester Brain and Spine Neuro	Rochester	New York
United States	Neurosurgery Associates	Salt Lake City	Utah
United States	Neurosurgery Associates	Scarborough	Maine
United States	Oregon Neurosurgery	Springfield	Oregon
United States	Washington University Orthopedics	St. Louis	Missouri
United States	Crouse Hospital	Syracuse	New York
United States	Upstate Orthopedics	Syracuse	New York
United States	Tallahassee Neurological Clinic	Tallahassee	Florida
United States	Neurosurgical Network, Inc.	Toledo	Ohio
United States	Bay Area Spine Institute	Walnut Creek	California
United States	Wake Forest University School of Medicine - Dept. of Neurosurgery Medical Center	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Spinal and Biologics

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in patient pain and ability to function	The self-administered Neck Disability Index patient questionnaire is used to assess patient pain and ability to function. A successful outcome will be declared if: Postoperative Score - Postoperative Score is = 15.	24 months	Yes