Intervertebral Disc Displacement
Conditions
Brief summary
This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc prosthetic devices with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
Interventions
Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
DEVICEAnterior cervical discectomy with prosthetic disc replacement / Rotaio.
Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.
Sponsors
Technische Universität Dresden
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis
Exclusion criteria
* Radiologic signs of extensive bone degeneration in the affected segment * Necessity of implantation of a device smaller in height than 5 mm (as predicted with teh use of the Vertaplan (TM) software * Transversal spine cord lesion * Cervical myelopathy * Preceding surgery on the cervical spine * Traumatic lesions of the cervical spine * Radiographic instability in the affected segment: flexion / extension: shift sagittal plane\> 3.5 mm or 20% and rotation in the sagittal plane \> 20 °, OR in static X-ray examinations: shift in the sagittal plane 3.5 mm or 20% of the vertebral body width and relative sagittal plane angulation \> 11º * signs of instability (Olisthesis) in another segment of the cervical spine * Active systemic infection * diseases of the rheumatic type and all autoimmune diseases * bone metabolic diseases (for example, Paget's disease) * skeletal metastases * infections in the cervical spine * Neurological seizure disorders or other serious neurological disease with risk of falls * Severe heart failure (NYHA III-IV) * Bleeding disorders or clopidogrel / coumarins - treatment * Systemic use of corticosteroids for more than a month in the last 12 months * Pregnancy * Legally incompetent patient * Lactation * Deformity, anomalies, not fully developed skeleton * Local tumor disease * Pre-existing neurologic abnormalities or other shortcomings, such as a Parkinson's disease, diabetic neuropathy, multiple sclerosis, peripheral neuropathy * Drug / drug or alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Neck disability index compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline | 6 weeks, 3, 6 and 12 months postoperative | — |
| Change in consumption of analgetics compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative | The change in analgetics consumption will be assessed on a scale of increase - stable - reduction. |
| Return to work | 6 weeks postoperative | — |
| Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative | — |
| Change in flexion and extension radiographs compared to baseline | 6 weeks, 3, 6 and 12 months postoperative | — |
| Change in Core Outcome Measure Index (COMI) compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative | — |
| Mortality | 6 weeks postoperative | — |
| Adverse effects | 6 weeks postoperative | — |
| Change in EuroQOL (EQ-5D) compared to baseline | 6 weeks, 3, 6, 12 and 24 months postoperative | — |
Countries
Germany
Outcome results
None listed