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.
ID
Bron
Verkorte titel
Aandoening
Cervical; Disc; Cage; Prothesis.
Cervicaal; Discus; Cage; Prothese.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The incidence of Accelerated Adjacent Disc Degeneration (AADD) after cervical disc arthroplasty and discectomy with or without fusion.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
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.
Onderzoeksproduct en/of interventie
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)
Publiek
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
Wetenschappelijk
SIPS-group Leiden-The Hague
Albinusdreef 2
Leiden 2333 ZA
The Netherlands
+31 (0)71 5262144
sips@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1243 |
| NTR-old | NTR1289 |
| Ander register | : P08.011 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |