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The Netherlands cervical kinetics trial, Neck


- candidate number3224
- NTR NumberNTR1289
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-apr-2008
- Secondary IDsP08.011 
- Public TitleThe Netherlands cervical kinetics trial, Neck
- Scientific TitleThe 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
- ACRONYMthe NE(therlands) C(ervical) K(inetics) trial
- hypothesisThe incidence of symptomatic adjacent disc generation after cervical disc arthroplasty is equal to anterior discectomy with or without interbody fusion at 2 years after surgery.
- Healt Condition(s) or Problem(s) studiedArthroplasty , Cervical disc herniation, Discectomy , Prothesis
- Inclusion criteria1. 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 criteria1. 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
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingDouble
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-mei-2018
- Target number of participants128
- InterventionsPatients 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 interbody fusion (ACDF or fusion)
Group C: anterior cervical discectomy with disc prothesis (ACPD or motion)
- Primary outcomeThe incidence of Accelerated Adjacent Disc Degeneration (AADD) after cervical disc arthroplasty and discectomy with or without fusion.
- Secondary outcome- 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).
- TimepointsFollow up of all patients will be performed at 8, 52, 104, 156, 208 and 260 weeks after surgery.
Questionnaires will be send by mail.
- Trial web siteN/A
- statusstopped: trial finished
- CONTACT FOR PUBLIC QUERIES SIPS-group Leiden-The Hague
- CONTACT for SCIENTIFIC QUERIESMw. Drs. L. Bosscher
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
B. Braun Medical B.V. Aesculap
- PublicationsN/A
- Brief summaryPatients with cervical radicular syndrome due to disc herniation refractory to conservative treatment are offered surgical treatment. Anterior cervical discectomy is the standard procedure, often in combination with interbody fusion to maintain disc height. Accelerated adjacent disc degeneration is a known entitity on the long term. Recently, cervical disc prosthesis are developed to maintain motion and possibly reduce the incidence of adjacent disc degeneration. Up till now, no randomised comparative trial has been performed between anterior discectomy with or without intercorporal fusion and disc prothesis.
- Main changes (audit trail)
- RECORD22-apr-2008 - 19-aug-2015


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