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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02936739
Other study ID # NCH_ESPvsRotaio
Secondary ID
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


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
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