A randomised multicenter study comparing anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation.

Phase 4

Completed

• Conditions: Armpain; cervical disc herniation; 10028377; 10041543; 10009720

• Registration Number: NL-OMON35197
• Lead Sponsor: Aesculap AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 750

Inclusion Criteria

·Age 18-65 years
·Radicular signs and symptoms in one or both arms
·At least 8 weeks prior conservative treatment
·Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level
.No previous cervical surgery
·Informed consent

Exclusion Criteria

.Increased motion on dynamic studies (> 3 mm)
·Involved disc level fused or very narrow
·Severe kyphosis of the involved disc level
·Neck pain only
·Infection
·Metabolic and bone diseases
·Neoplasma or trauma
·Spinal anomaly (Klippel Feil, Bechterew, OPLL)
·Severe mental or psychiatric disorder
·Inadequate Dutch language

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> The functional assessment of the patient self on an illness specific<br /><br>questionnaire: *Neck Disability Index*. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Neck and arm pain (VAS), quality of life (SF-36), emotional status determined<br /><br>by the Hospital Anxiety Depression Scale (HADS), work experience measured by<br /><br>the Karasek Job Content Questionnaire, perceived recovery of the patient,<br /><br>researchnurse and surgeon (Likert and Macnab), complications, incidence of<br /><br>re-operations, costs (direct and indirect) and incidence of adjacent disc<br /><br>degeneration (criteria of Hilibrand and Goffin).</p><br>