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

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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON35197

Enrollment

750

Registered

2008-04-17

Start date

2010-10-11

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Armpain cervical disc herniation

Interventions

Patients will be randomised in 3 groups: anterior discectomy without interbody fusion, anterior discectomy with interbody fusion, and anterior discectomy with Active C disc prosthesis.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The functional assessment of the patient self on an illness specific questionnaire: Neck Disability Index.	—

Secondary

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

Measure

Time frame

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

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)