Interbody fusion devices in the treatment of cervicobrachial syndrome; a blinded randomised trial of cancellous structured ceramic (CSC) versus PEEK cages.

Phase 4

Completed

• Conditions: cervical herniated disc; 10028377; 10041543; 10009720

• Registration Number: NL-OMON41376
• Lead Sponsor: Amedica Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

* Age between 18 - 75 years.
* Radicular signs and symptoms in one or both arms (i.e., pain, paraesthesiae or paresis in a specific nerve root distribution) or symptoms and signs of acute or chronic myelopathy.
* At least 8 weeks prior conservative treatment (i.e., physical therapy, pain medication).
* Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level (C3-C4 to C7-T1) in accordance with clinical signs and symptoms.
* Written informed consent .

Exclusion Criteria

* Previous cervical surgery (either anterior or posterior).
* Increased motion on dynamic studies (> 3 mm).
* Severe segmental kyphosis of the involved disc level (> 7 degrees).
* Patient cannot be imaged with MRI.
* Neck pain only (without radicular or medullary symptoms).
* Infection.
* Metabolic and bone diseases (osteoporosis, severe osteopenia).
* Neoplasma or trauma of the cervical spine.
* Spinal anomaly (Klippel Feil, Bechterew, OPLL).
* Severe mental or psychiatric disorder.
* Inadequate Dutch language.
* Planned (e)migration abroad in the year after inclusion.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Neck Disability Index (NDI)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neckpain, armpain, patient's perceived recovery, fusion, EuroQol, re-operations<br /><br>and complications.</p><br>