NCT02852187

Brief Summary

Prospective randomized clinical study comparing SIGNUS MOBIS PEEK vs SIGNUS MOBIS II ST in patients with Degenerative Disc Disease at one or two contiguous levels from L2-S1

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

July 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 18, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

August 2, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

March 19, 2020

Status Verified

March 1, 2020

Enrollment Period

2.3 years

First QC Date

July 18, 2016

Last Update Submit

March 17, 2020

Conditions

Lumbar Disc Disease

Keywords

Intervertebral Disc DegenerationLumbar Spinal Disease

Outcome Measures

Primary Outcomes (1)

  • Fusion rates

    Lumbar fusion demonstrated by radiographic evidence based on plain radiographs, and CT Scans

    24 Months

Secondary Outcomes (4)

  • Subsidence

    24 Months

  • Patient Reported Outcomes: Visual Analog Scale (VAS)

    Through 24 Months

  • Patient Reported Outcomes: Oswestry Disability Index

    Through 24 Months

  • Patient Reported Outcomes: Evaluations of Quality of Life (QOL) by the EQ-5D-5L

    Through 24 Months

Study Arms (2)

MOBIS PEEK

ACTIVE COMPARATOR

Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS PEEK Cage

Device: SIGNUS MOBIS PEEK Cage

MOBIS II ST

ACTIVE COMPARATOR

Transforaminal Lumbar Interbody Fusion (TLIF) with the SIGNUS MOBIS II ST Cage

Device: SIGNUS MOBIS II ST Cage

Interventions

SIGNUS MOBIS PEEK CageDEVICE

Lumbar Interbody Fusion

MOBIS PEEK
SIGNUS MOBIS II ST CageDEVICE

Lumbar Interbody Fusion

MOBIS II ST

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient has symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1.
  • The patient has documented conservative (non-operative) treatment for at least 6 months.
  • The patient has a VAS back pain of ≥ 60 mm.
  • The patient has an ODI ≥ 40%.
  • The patient is at least 18 years of age and skeletally mature.
  • The general condition of the patient is appropriate for surgery, as evaluated by the Investigator.
  • The patient is willing and able to comply with study requirements.
  • The patient has agreed to participate in the study.

You may not qualify if:

  • The patient has undergone any prior spinal fusion surgery at the proposed treatment level(s).
  • The patient has osteoporosis or severe osteopenia as determined by the Investigator. A clinical SCORE calculator may be utilized for females over 40 years of age.
  • The patient has grade 2 or higher spondylolisthesis or retrolisthesis at the affected level(s).
  • The patient has diffuse multilevel neoplastic disease such that no adjacent normal segments exist for engagement or instrumentation.
  • The patient has an active infection.
  • The patient is pregnant or is planning on becoming pregnant in the next two years.
  • The patient is mentally ill or has a history of drug abuse or severe depression/ psychosocial issues.
  • The patient has a known allergy to polyether ether ketone (PEEK), stainless steel or tantalum/titanium.
  • The patient is currently enrolled in an investigational spine study.
  • The patient has rheumatoid arthritis, ankylosing spondylitis or other autoimmune disease.
  • The patient has symptomatic fibrous arachnoiditis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Upstate Orthopedics

East Syracuse, New York, 13057, United States

Location

MeSH Terms

Conditions

Intervertebral disc diseaseIntervertebral Disc DegenerationSpinal Diseases

Condition Hierarchy (Ancestors)

Bone DiseasesMusculoskeletal Diseases

Study Officials

  • William F. Lavelle, MD

    Upstate Orthopedics

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2016

First Posted

August 2, 2016

Study Start

July 1, 2016

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

March 19, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)