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

Medtronic

Status: Completed

Conditions: Radiculopathy; Myelopathy; Cervical Degenerative Disc Disease

Treatments: Device: ATLANTIS™ Cervical Plate System and allograft; Device: BRYAN Cervical Disc Prosthesis

Study type: Interventional

Funder types: Industry

Identifiers

NCT00437190

BRYAN(R) Cervical Disc IDE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 494 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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494 participants in 2 patient groups

Anterior Cervical Discectomy Fusion

Active Comparator group

Treatment:

Device: ATLANTIS™ Cervical Plate System and allograft

BRYAN Cervical Disc Prosthesis

Experimental group

Description:

BRYAN Cervical Disc Prosthesis is a cervical intervertebral disc prosthesis designed to provide for motion like the normal cervical functional spinal unit.

Treatment:

Device: BRYAN Cervical Disc Prosthesis