Vertebral Osteosynthesis in Degenerative Lumbar Stenosis... | NCT00252551

Studies
Vertebral Osteosynthesis in Degenerative Lumbar Stenosis With Spondylolisthesis

NCT00252551

Sponsor

University Hospital, Toulouse

Status

Terminated

Last Update Posted

Mar 17, 2015Estimated

Enrollment

11Actual

Phase

Not Applicable

Conditions

Spondylolisthesis

Interventions

Osteosynthesis
Simple surgery

Countries

France

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

ID	Type	Description	Link
PHRC0300201	Other Grant/Funding Number	French Ministry of Health

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Insufficient recruitment

Expanded Access Info

Start Date

Mar 2005

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 10, 2005

First Submission Date that Met QC Criteria

Nov 10, 2005

First Posted Date

Nov 11, 2005Estimated

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

Mar 15, 2015

Last Update Posted Date

Mar 17, 2015Estimated

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

Study to evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylolisthesis

Detailed Description

Randomized, comparative study on 152 patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months.

Patients randomized in 2 parallel groups (each group with 76 patients)

one group with decompressive surgery + osteosynthesis
one group with decompressive surgery Study duration : 18 months, including a selection visit, an inclusion with the surgical intervention, 3, 12, 18 months' follow up visits and a follow up call at 6 months.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	osteosynthesis	Procedure: Osteosynthesis
2	Active Comparator	Simple surgery	Procedure: Simple surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Osteosynthesis	Procedure		1
Simple surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the superiority of the osteosynthesis associated with a decompressive surgery in comparison with a simple decompressive surgery in the treatment of lumbar degenerative stenosis with spondylisthesis		M3, M12, M18

Secondary Outcomes

Measure	Description	Time Frame
improvement of patients' Quality of Life (SF36)		M18
radiologic stability of spondylolisthesis		M18
safety of the used surgical procedures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with degenerative spondylolisthesis L4-L5 confirmed by radiography with radicular pain for whom the antalgic and anti-inflammatory treatment are not efficient for at least 3 months;
Patients who agree to take part in the study and to sign an Informed Consent Form

Exclusion Criteria:

Contre-indications to surgery or to vertebral isolated fixation L4-L5
Previous lumbar surgery
Work accidents
Psychiatric troubles that may interfere with the clinical evaluation
Pregnant women or women who could be pregnant during the study
Patient under special supervision or trusteeship
Refusal to sign the Informed Consent Form
No Public Health Insurance cover

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques Lagarrigue	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Besançon - Neurosurgey department		Besançon		25030	France
University Hospital of Caen - Neurosurgery department

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
1403105	Background	Caputy AJ, Luessenhop AJ. Long-term evaluation of decompressive surgery for degenerative lumbar stenosis. J Neurosurg. 1992 Nov;77(5):669-76. doi: 10.3171/jns.1992.77.5.0669.
8073310	Background	Cherkin DC, Deyo RA, Loeser JD, Bush T, Waddell G. An international comparison of back surgery rates. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1201-6. doi: 10.1097/00007632-199405310-00001.

ID	Term
D013169	Spondylolysis
D055009	Spondylosis
D013122	Spinal Diseases
D001847	Bone Diseases

ID	Term
D005592	Fracture Fixation
D019637	Orthopedic Procedures
D013812	Therapeutics
D013514	Surgical Procedures, Operative