The Netherlands cervical kinetics trial, Neck

The Netherlands cervical kinetics trial: effectiveness of anterior cervical discectomy with or without interbody fusion and arthroplasty in the treatment of cervical disc herniation; a blinded randomised multicenter study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27181

Enrollment

128

Registered

2008-04-22

Start date

2010-05-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Cervical

Interventions

Patients who fit the in- and exclusiecriteria for the trial will be randomised into three groups. Group A: anterior cervical discectomy (ACD or sec) Group B: anterior cervical discectomy with interb

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18-65 years 2. Radicular signs and symptoms in one or both arms 3. At least 8 weeks prior conservative treatment 4. Radiographic diagnosis of cervical disc herniation and/or osteophyte at 1 level 5. No previous cervical surgery 6. Informed consent

Exclusion criteria

Exclusion criteria: 1. Increased motion on dynamic studies (> 3 mm) 2. Involved disc level fused or very narrow 3. Severe kyphosis of the involved disc level 4. Neck pain only 5. Infection 6. Metabolic and bone disease 7. Neoplasma or trauma 8. Spinal anomaly (Klippel Feil, Bechterev, OPLL) 9. Severe mental or psychiatric disorder 10. Inadequate Dutch language

Design outcomes

Primary

Measure	Time frame
The incidence of Accelerated Adjacent Disc Degeneration (AADD) after cervical disc arthroplasty and discectomy with or without fusion.	—

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) - complications - incidence of re-operations - costs (direct and indirect) - 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) - complications - incidence of re-operations - costs (direct and indirect) - incidence of adjacent disc degeneration (criteria of Hilibrand and Goffin).

—

Contacts

Public ContactSIPS-group Leiden-The Hague

LUMC, afdeling neurochirurgie

sips@lumc.nl+31 (0)71 5262144

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)