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

Tracking Information
First Submitted Date ICMJE	February 16, 2007
First Posted Date ICMJE	February 19, 2007
Last Update Posted Date	May 13, 2016
Study Start Date ICMJE	June 2003
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: October 14, 2011)	Improvement in patient pain and ability to function [ Time Frame: 24 months ]; 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.
Original Primary Outcome Measures ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00437190 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF
Official Title ICMJE	Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of Degenerative Disc Disease
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Radiculopathy; Myelopathy; Cervical Degenerative Disc Disease
Intervention ICMJE	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. Other Names: cervical plate plate fusion cervical fusion; Device: 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. Other Names: disc cervical disc artificial disc BRYAN
Study Arms	Active Comparator: Anterior Cervical Discectomy Fusion Intervention: Device: ATLANTIS™ Cervical Plate System and allograft; Experimental: BRYAN Cervical Disc Prosthesis BRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit. Intervention: Device: BRYAN Cervical Disc Prosthesis
Publications *	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.; 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.; 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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: October 14, 2011)	494
Original Enrollment ICMJE	Not Provided
Actual Study Completion Date	May 2016
Actual Primary Completion Date	December 2006 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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.
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00437190
Other Study ID Numbers ICMJE	BRYAN(R) Cervical Disc IDE
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Medtronic Spinal and Biologics
Study Sponsor ICMJE	Medtronic Spinal and Biologics
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Rick C Sasso, MD Indiana Spine Group
PRS Account	Medtronic Spinal and Biologics
Verification Date	May 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP