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

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.

Study Overview

• Status: Unknown
• Conditions: Intervertebral Disc Displacement
• Intervention / Treatment: Device: Anterior cervical discectomy with prosthetic disc replacement / ESP.; Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio.

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Dresden, Germany, 01307
    • Recruiting
    • Uniklinikum Dresden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Elastic spine pad; Patients, who receive Elastic Spine Pad (TM) as cervical disc prosthesis after ventral discectomy.	Device: 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.
Active Comparator: Rotaio; Patients, who receive Rotaio (TM) as cervical disc prosthesis after ventral discectomy.	Device: Anterior cervical discectomy with prosthetic disc replacement / Rotaio.; Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Neck disability index compared to baseline	6 weeks, 3, 6, 12 and 24 months postoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Core Outcome Measure Index (COMI) compared to baseline		6 weeks, 3, 6, 12 and 24 months postoperative
Change in flexion and extension radiographs compared to baseline		6 weeks, 3, 6 and 12 months postoperative
Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline		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.	6 weeks, 3, 6, 12 and 24 months postoperative
Return to work		6 weeks postoperative
Return to work		3 months postoperative
Return to work		6 months postoperative
Return to work		12 months postoperative
Return to work		24 months postoperative
Mortality		6 weeks postoperative
Mortality		3 months postoperative
Mortality		6 months postoperative
Mortality		12 months postoperative
Mortality		24 months postoperative
Adverse effects		6 weeks postoperative
Adverse effects		3 months postoperative
Adverse effects		6 months postoperative
Adverse effects		12 months postoperative
Adverse effects		24 months postoperative

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): June 1, 2019

Study Registration Dates

• First Submitted: October 13, 2016
• First Submitted That Met QC Criteria: October 14, 2016
• First Posted (Estimate): October 18, 2016

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement
• Other Study ID Numbers: NCH_ESPvsRotaio

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No