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

Intervertebral Disc Displacement Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02936739
• Other study ID #: NCH_ESPvsRotaio
• Status: Recruiting
• Phase: N/A
• First received: October 13, 2016
• Last updated: October 14, 2016
• Start date: June 2016
• Est. completion date: June 2019

Study information

• Verified date: October 2016
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: June 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Intervertebral Disc Displacement

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Uniklinikum Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neck disability index compared to baseline		6 weeks, 3, 6, 12 and 24 months postoperative	No
Secondary	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	No
Secondary	Change in EuroQOL (EQ-5D) compared to baseline		6 weeks, 3, 6, 12 and 24 months postoperative	No
Secondary	Change in Core Outcome Measure Index (COMI) compared to baseline		6 weeks, 3, 6, 12 and 24 months postoperative	No
Secondary	Change in flexion and extension radiographs compared to baseline		6 weeks, 3, 6 and 12 months postoperative	No
Secondary	Change in and computer aided measurement of segmental height degeneration in adjacent segments compared to baseline		6 weeks, 3, 6 and 12 months postoperative	No
Secondary	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	No
Secondary	Return to work		6 weeks postoperative	No
Secondary	Return to work		3 months postoperative	No
Secondary	Return to work		6 months postoperative	No
Secondary	Return to work		12 months postoperative	No
Secondary	Return to work		24 months postoperative	No
Secondary	Mortality		6 weeks postoperative	Yes
Secondary	Mortality		3 months postoperative	Yes
Secondary	Mortality		6 months postoperative	Yes
Secondary	Mortality		12 months postoperative	Yes
Secondary	Mortality		24 months postoperative	Yes
Secondary	Adverse effects		6 weeks postoperative	Yes
Secondary	Adverse effects		3 months postoperative	Yes
Secondary	Adverse effects		6 months postoperative	Yes
Secondary	Adverse effects		12 months postoperative	Yes
Secondary	Adverse effects		24 months postoperative	Yes