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

NCT ID: NCT02936765

Last Updated: 2016-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2019-06-30

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.

Conditions

Intervertebral Disc Displacement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Elastic spine pad

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

Group Type: EXPERIMENTAL

Anterior cervical discectomy with prosthetic disc replacement / ESP.

Intervention Type: DEVICE

Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.

Squale

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

Group Type: ACTIVE_COMPARATOR

Anterior cervical discectomy with prosthetic disc replacement / Squale.

Intervention Type: DEVICE

Anterior cervical discectomy, with the use of the Squale spacer (Manufacturer: OSD, Avignon, France) for the disc replacement.

Interventions

Anterior cervical discectomy with prosthetic disc replacement / ESP.

Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.

Intervention Type: DEVICE

Anterior cervical discectomy with prosthetic disc replacement / Squale.

Anterior cervical discectomy, with the use of the Squale spacer (Manufacturer: OSD, Avignon, France) for the disc replacement.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technische Universität Dresden

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Uniklinikum Dresden

Dresden, , Germany

Site Status: RECRUITING

Countries

Germany

Facility Contacts

Bernhard Rieger, Dr.

Role: primary

bernhard.rieger@uniklinikum-dresden.de

Other Identifiers

NCH_ESPvsSquale

Identifier Type: -

Identifier Source: org_study_id