Interbody fusion in the treatment of cervicobrachial syndrome; a prospective trial of porous titanium cervical cages.
- Conditions
- cervical herniated disc100283771004154310009720
- Registration Number
- NL-OMON43762
- Lead Sponsor
- neurochirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
* Age 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 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.
* Previous cervical surgery (either anterior or posterior)
* Increased motion on dynamic studies (> 3 mm)
* Neck pain only (without radicular or medullary symptoms)
* Infection
* Osteoporosis
* 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
. Pregnancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome measure is improvement in the Neck and Disability Index<br /><br>(NDI) one year after surgery. </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcome measure is the temporal evaluation of bony fusion using<br /><br>dynamic lateral flexion-extension radiographs that will be quantitatively<br /><br>analysed. Other outcome measures include improvement in arm pain and neck pain<br /><br>(VAS), EuroQol-5D, patients' perceived recovery, and perioperative variables<br /><br>including operating time, blood loss, length of hospital stay, and adverse<br /><br>events.</p><br>