To show whether Active C disc prosthesis is more effective than anterior discectomy with or without interbody fusion 1 year after surgery. Moreover, the incidence of adjacent disc degeneration will be evaluated 5 years after surgery.
ID
Source
Brief title
Condition
- Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders)
- Spinal cord and nerve root disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The functional assessment of the patient self on an illness specific
questionnaire: *Neck Disability Index*.
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 and Macnab), complications, incidence of
re-operations, costs (direct and indirect) and incidence of adjacent disc
degeneration (criteria of Hilibrand and Goffin).
Background summary
Patients 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
prosthesis.
Study objective
To show whether Active C disc prosthesis is more effective than anterior
discectomy with or without interbody fusion 1 year after surgery. Moreover, the
incidence of adjacent disc degeneration will be evaluated 5 years after
surgery.
Study design
The study is a multicenter randomised trial with a follow-up period of 5 years.
Intervention
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.
Study burden and risks
Besides the known complications of an anterior cervical approach, there are
implant related risks like displacement, subsidence, or breakage. The
outpatient control will be more frequently than usual and patients are asked to
fill out several questionnaires.
Am Aesculapplatz
D - 78532 Tuttlingen
DE
Am Aesculapplatz
D - 78532 Tuttlingen
DE
Listed location countries
Age
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
Design
Recruitment
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL21327.058.08 |