A multi center, prospective, randomized controlled trial comparing cervical arthroplasty to anterior cervical discectomy and fusion (ACDF) for the treatment of cervical degenerative disc disease.

Phase 4

Recruiting

Conditions: 10019190
Cervical disc disease

Registration Number: NL-OMON39490

Lead Sponsor: Johnson & Johnson

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

Key Inclusion Criteria:;- Objective evidence of cervical disc disease in 1 vertebral level between C3-C7 defined as
(a) shoulder and/or arm pain in a documented radicular distribution resulting from herniated disc or bony osteophytes or
(b)myeloradiculopathy resulting from mild spinal cord compression and nerve root impingement
- Unresponsiveness to documented non-surgical management for greater than or equal to 6 weeks and/or presentation with progressive symptoms of nerve root or spinal cord compression in the face of continued non-surgical management
- Moderate Neck Disability Index (NDI) score
- Able to give informed consent for study participation
- Able and willing to return for all follow-up visits

Exclusion Criteria

Key Exclusion Criteria:;- Significant cervical degenerative disc disease
- Prior fusion procedure at any level(s) (C1-T1)
- Marked cervical instability on lateral or flexion/extension radiographs
- Presence of systemic infection or infection at the surgical site
- Diagnosis of a condition, or requires postoperative medication(s), which may interfere with bony/soft tissue healing
- History of alcohol and/or drug abuse
- Any known allergy to a metal alloy or polyethylene
- Morbid obesity
- Any significant general illness (e.g., metastatic cancer, HIV)

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>The primary endpoint is patient success as determined by clinical outcome<br /><br>measures.<br /><br>1)Clinical Success requires a minimum of 15-point improvement in NDI,<br /><br>2) no new clinically significant permanent abnormalities in neurological<br /><br>function (i.e., motor strength, nerve<br /><br>root tension signs, sensory and reflex signs),<br /><br>3) no subsequent secondary surgical interventions at the index level, and no<br /><br>device-related serious adverse<br /><br>events (SAE) from baseline through 24-months </p><br>

Secondary Outcome Measures