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

NCT02936739 | Unknown

• 1 other identifier: NCH_ESPvsRotaio
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intervertebral Disc Displacement

Outcome Measures

Primary Outcomes (1)

• Change in Neck disability index compared to baseline

  6 weeks, 3, 6, 12 and 24 months postoperative

Secondary Outcomes (21)

• 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

Study Arms (2)

Elastic spine pad

EXPERIMENTAL

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

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

Rotaio

ACTIVE COMPARATOR

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

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

Interventions

Anterior cervical discectomy with prosthetic disc replacement / ESP. DEVICE

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

Elastic spine pad

Anterior cervical discectomy with prosthetic disc replacement / Rotaio. DEVICE

Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.

Rotaio

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Indication for monosegmental anterior cervical discectomy with implantation of a disc prosthesis

You may not qualify if:

• 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)

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

Uniklinikum Dresden

Dresden, 01307, Germany

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 18, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2018
• Study Completion: June 1, 2019
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

DE (1)