NCT01551901

Brief Summary

The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2012

Typical duration for not_applicable

Geographic Reach
2 countries

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 13, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

September 19, 2014

Status Verified

September 1, 2014

Enrollment Period

2.9 years

First QC Date

February 2, 2012

Last Update Submit

September 18, 2014

Conditions

Lower Back PainDegenerative Disc Disease (DDD)

Keywords

Back painSpinal fusionDegenerative disc disease (DDD)Lower back painFusion

Outcome Measures

Primary Outcomes (5)

  • Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event

    12 Month Post-op

  • Improvement in pain score on the Visual Analog Scale (VAS) from baseline

    12 Month Post-op

  • Maintenance or improvement of neurologic function related to the spine

    12 Month Post-op

  • Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation

    12 Month Post-op

  • Improvement in Oswestry Disability Index (ODI) score from baseline

    12 Month Post-op

Secondary Outcomes (3)

  • Improvement from baseline in quality of life as measured by SF-36

    12 Month Post-op

  • Rate of device-related serious adverse events

    12 Month Post-op

  • Proportion of subjects with radiographic fusion of target segments

    12 Month Post-op

Study Arms (1)

Luna Interbody System

EXPERIMENTAL
Device: Spinal fusion

Interventions

Spinal fusionDEVICE

Spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to grade 1 spondylolisthesis

Also known as: Luna Interbody System
Luna Interbody System

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 - 65 at the time of consent
  • Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.
  • Patient has had at least 6 months of non-operative care
  • Patient is mentally capable and willing to sign a study-specific informed consent form
  • Patient is willing and able to comply with all study requirements
  • Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm
  • Patient has an Oswestry Disability Index (ODI) score of ≥ 30%

You may not qualify if:

  • DDD affecting \>2 levels
  • Back pain due to causes other than DDD
  • Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure
  • \>Grade 1 spondylolisthesis or retrolisthesis
  • Infection at or close to target disc level
  • Active systemic infection
  • Patient has known osteoporosis
  • Prior interbody fusion at the target level
  • Prior failed interbody fusion at any level
  • Known allergy to device materials
  • Uncontrolled psychiatric illness or severe dementia
  • Pregnant at time of enrollment or considering getting pregnant during study period
  • Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement.
  • Any severe illness that would prevent complete study participation
  • Uncontrolled diabetes
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clinique du Parc Leopold

Brussels, 1040, Belgium

Location

Hôpital Erasme

Brussels, 1070, Belgium

Location

CHC Liege

Liège, Belgium

Location

Universitatsklinikum Bonn

Bonn, 53105, Germany

Location

Paracelsus Kliniken

Zwickau, 08008, Germany

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc DegenerationBack Pain

Interventions

Spinal Fusion

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

ArthrodesisOrthopedic ProceduresSurgical Procedures, Operative

Study Officials

  • Alphonse Lubansu, M.D.

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2012

First Posted

March 13, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

September 19, 2014

Record last verified: 2014-09

Locations

DE(2)BE(3)