No registrations found.
ID
Source
Brief title
Health condition
Cervical; Disc; Cage; Prothesis.
Cervicaal; Discus; Cage; Prothese.
Sponsors and support
Intervention
Outcome measures
Primary outcome
The 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).
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 prothesis.
Study objective
The 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.
Study design
Follow up of all patients will be performed at 8, 52, 104, 156, 208 and 260 weeks after surgery.
Questionnaires will be send by mail.
Intervention
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 interbody fusion (ACDF or fusion)
Group C: anterior cervical discectomy with disc prothesis (ACPD or motion)
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
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
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
Recruitment
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 |
|---|---|
| NTR-new | NL1243 |
| NTR-old | NTR1289 |
| Other | : P08.011 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |