This is an investigator-initiated study. The primary goal is to evaluate the efficacy of two different cervical disc devices (prosthesis vs rigid spacer) with respect to postoperative change in neck disability index. The evaluation will include clinical and radiological parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
Anterior cervical discectomy, with the use of the Squale spacer (Manufacturer: OSD, Avignon, France) for the disc replacement.
Uniklinikum Dresden
Dresden, Germany
RECRUITINGChange in Neck disability index compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in EuroQOL (EQ-5D) compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in Core Outcome Measure Index (COMI) compared to baseline
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Change in flexion and extension radiographs compared to baseline (angle difference [deg]).
Time frame: 6 weeks, 3, 6 and 12 months postoperative
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm])
Time frame: 6 weeks, 3, 6 and 12 months postoperative
Change in consumption of analgetics compared to baseline
The change in analgetics consumption will be assessed on a scale of increase - stable - reduction.
Time frame: 6 weeks, 3, 6, 12 and 24 months postoperative
Return to work
Time frame: 6 weeks postoperative
Return to work
Time frame: 3 months postoperative
Return to work
Time frame: 6 months postoperative
Return to work
Time frame: 12 months postoperative
Return to work
Time frame: 24 months postoperative
Mortality
Time frame: 6 weeks postoperative
Mortality
Time frame: 3 months postoperative
Mortality
Time frame: 6 months postoperative
Mortality
Time frame: 12 months postoperative
Mortality
Time frame: 24 months postoperative
Adverse effects
Time frame: 6 weeks postoperative
Adverse effects
Time frame: 3 months postoperative
Adverse effects
Time frame: 6 months postoperative
Adverse effects
Time frame: 12 months postoperative
Adverse effects
Time frame: 24 months postoperative
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