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
Not Applicable
- Conditions
- Intervertebral Disc Displacement
- Interventions
- Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.Device: Anterior cervical discectomy with prosthetic disc replacement / Squale.
- Registration Number
- NCT02936765
- Lead Sponsor
- Technische Universität Dresden
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 52
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Elastic spine pad Anterior cervical discectomy with prosthetic disc replacement / ESP. Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy. Squale Anterior cervical discectomy with prosthetic disc replacement / Squale. Patients, who receive Squale (TM) as cervical disc prosthesis after ventral discectomy.
- Primary Outcome Measures
Name Time Method Change in Neck disability index compared to baseline 6 weeks, 3, 6, 12 and 24 months postoperative
- Secondary Outcome Measures
Name Time Method Change in Core Outcome Measure Index (COMI) compared to baseline 6 weeks, 3, 6, 12 and 24 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.
Adverse effects 24 months postoperative Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline (distance difference [mm]) 6 weeks, 3, 6 and 12 months 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 EuroQOL (EQ-5D) compared to baseline 6 weeks, 3, 6, 12 and 24 months postoperative Change in flexion and extension radiographs compared to baseline (angle difference [deg]). 6 weeks, 3, 6 and 12 months postoperative Mortality 24 months postoperative Return to work 24 months postoperative
Trial Locations
- Locations (1)
Uniklinikum Dresden
🇩🇪Dresden, Germany