Clinical trial NCT02936765: Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Spacer Squale (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Intervertebral Disc Displacement
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Neck disability index compared to baseline
timeFrame: 6 weeks, 3, 6, 12 and 24 months postoperative
Secondary outcomes:
measure: Change in visual analogue scale for pain in the neck and peripheral pain compared to baseline
timeFrame: 6 weeks, 3, 6, 12 and 24 months postoperative
measure: Change in EuroQOL (EQ-5D) compared to baseline
timeFrame: 6 weeks, 3, 6, 12 and 24 months postoperative
measure: Change in Core Outcome Measure Index (COMI) compared to baseline
timeFrame: 6 weeks, 3, 6, 12 and 24 months postoperative
measure: Change in flexion and extension radiographs compared to baseline (angle difference [deg]).
timeFrame: 6 weeks, 3, 6 and 12 months postoperative
measure: Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm])
timeFrame: 6 weeks, 3, 6 and 12 months postoperative
measure: Change in consumption of analgetics compared to baseline
timeFrame: 6 weeks, 3, 6, 12 and 24 months postoperative
measure: Return to work
timeFrame: 6 weeks postoperative
measure: Return to work
timeFrame: 3 months postoperative
measure: Return to work
timeFrame: 6 months postoperative
measure: Return to work
timeFrame: 12 months postoperative
measure: Return to work
timeFrame: 24 months postoperative
measure: Mortality
timeFrame: 6 weeks postoperative
measure: Mortality
timeFrame: 3 months postoperative
measure: Mortality
timeFrame: 6 months postoperative
measure: Mortality
timeFrame: 12 months postoperative
measure: Mortality
timeFrame: 24 months postoperative
measure: Adverse effects
timeFrame: 6 weeks postoperative
measure: Adverse effects
timeFrame: 3 months postoperative
measure: Adverse effects
timeFrame: 6 months postoperative
measure: Adverse effects
timeFrame: 12 months postoperative
measure: Adverse effects
timeFrame: 24 months postoperative
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: Uniklinikum Dresden
Study officials:
References: