Comparison of Software-assisted Implantation of Elastic S... | NCT02936765

Studies
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

NCT02936765

Sponsor

Technische Universität Dresden

Status

Unknown status

Last Update Posted

Oct 18, 2016Estimated

Enrollment

52Estimated

Phase

Not Applicable

Conditions

Intervertebral Disc Displacement

Interventions

Anterior cervical discectomy with prosthetic disc replacement / ESP.
Anterior cervical discectomy with prosthetic disc replacement / Squale.

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Oct 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2016

Primary Completion Date

Dec 2018Estimated

Completion Date

Jun 2019Estimated

First Submitted Date

Oct 13, 2016

First Submission Date that Met QC Criteria

Oct 14, 2016

First Posted Date

Oct 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2016

Last Update Posted Date

Oct 18, 2016Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

52Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.
Squale	Active Comparator	Patients, who receive Squale (TM) as cervical disc prosthesis after ventral discectomy.	Device: Anterior cervical discectomy with prosthetic disc replacement / Squale.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms