Comparison of Software-assisted Implantation of Elastic Spine Pad (TM) With Respect to Postoperative Change in Neck Disability Index (NDI) With the Conventional Disc Prosthesis Rotaio (TM) After Anterior Cervical Discectomy for Cervical Disc Prolapse

Technische Universität Dresden

Status: Unknown

Conditions: Intervertebral Disc Displacement

Treatments: Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio.; Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.

Study type: Interventional

Funder types: Other

Identifiers

NCT02936739

NCH_ESPvsRotaio

Details and patient eligibility

About

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.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Elastic spine pad

Experimental group

Description:

Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy.

Treatment:

Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.

Rotaio

Active Comparator group

Description:

Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy.

Treatment:

Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio.