Trial to Show Non-inferiority / Superiority of an Endosco... | NCT01622413

Studies
Trial to Show Non-inferiority / Superiority of an Endoscopic Transforaminal Discectomy to Standard Microdiscectomy

NCT01622413

Sponsor

Joimax GmbH

Status

Withdrawn

Last Update Posted

Sep 25, 2017Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Lumbar Disc Herniation

Interventions

joimax TESSYS
Microdiscectomy

Countries

Austria
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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patients did not consent to randomization in any study center, since they preferred endoscopic surgery. The recruitment of patients was impossible.

Expanded Access Info

Start Date

Sep 2013

Primary Completion Date

Jan 2017Estimated

Completion Date

Sep 22, 2017Actual

First Submitted Date

Jun 12, 2012

First Submission Date that Met QC Criteria

Jun 14, 2012

First Posted Date

Jun 19, 2012Estimated

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

Sep 22, 2017

Last Update Posted Date

Sep 25, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study compares an endoscopic transforaminal surgical technique for the treatment of a herniated disc to the standard microsurgical procedure. Clinical parameters as well as health economy will be assessed.

The study hypothesis is that the endoscopic approach is equivalent or superior to microdiscectomy.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endscopy	Experimental		Procedure: joimax TESSYS
Microsurgery	Active Comparator		Procedure: Microdiscectomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
joimax TESSYS	Procedure	Transforaminal Endoscopic Surgery System	Endscopy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in Oswestry Disability Index at 4 years		total follow-up period of 4 years

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in Quality of Life (SF-12)		total follow-up period of 4 years
Health resources consumption		total follow-up period of 4 years
Complication rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

symptomatic lumbar disc herniation
clinical and radiological evidence of nerve root compression
failure of conservative treatment for at least 6 weeks

Exclusion Criteria:

previous lumbar spine surgery
severe or progressive motor deficit
BMI > 40
cauda equina syndrome

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carl H Fürstenberg, MD	University Clinic Heidelberg, Department of Orthopedics, Traumatology and Paraplegiology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Clinic of Neurosurgery		Graz		8036	Austria
Ligamenta Spine Center

Condition Browse Module

MeSH Terms

ID	Term
D007405	Intervertebral Disc Displacement

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D006547	Hernia

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C004551	TES

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided