NCT01491373

Brief Summary

This study is designed to evaluate the feasibility of recombinant human bone morphogenetic protein-2 and absorbable collagen sponge with the tapered interbody fusion device (LT-CAGE® ) for anterior lumbar interbody fusion in patients with degenerative disc disease.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 1997

Typical duration for not_applicable

Status
completed

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, 1997

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 1999

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 1999

Completed
12.3 years until next milestone

First Submitted

Initial submission to the registry

December 12, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
Last Updated

August 2, 2013

Status Verified

December 1, 2011

Enrollment Period

2.7 years

First QC Date

December 12, 2011

Last Update Submit

August 1, 2013

Conditions

Degeneration of Lumbar Intervertebral Disc

Keywords

Degenerative Disc DiseaseSymptomatic Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

  • Fusion

    24 month

Secondary Outcomes (3)

  • Pain Assessment (Oswestry Disability Index, ODI)

    24 month

  • Neurological Status Assessment

    24 month

  • Health status assessment (SF-36)

    24 month

Study Arms (2)

rhBMP-2/ACS

EXPERIMENTAL
Device: rhBMP-2/ACS/LT-CAGE® Device

Autograft

ACTIVE COMPARATOR
Device: Autograft/LT-CAGE® Device

Interventions

rhBMP-2/ACS/LT-CAGE® DeviceDEVICE

rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.

Also known as: Recombinant human bone morphogenetic protein-2
rhBMP-2/ACS
Autograft/LT-CAGE® DeviceDEVICE

LT-CAGE® device filled with autogenous bone taken from the patient's iliac crest

Also known as: Autogenous bone graft
Autograft

Eligibility Criteria

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

You may qualify if:

  • Has degenerative disc disease as noted by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies.
  • Has no greater than Grade 1 spondylolisthesis utilizing Meyerding's Classification (Meyerding HW, 1932.)
  • Has single level symptomatic degenerative involvement from L2 to S1.
  • Is between the ages of 18 and 65, inclusive, at the time of surgery.
  • Is willing to comply with the study plan and sign the Patient Informed Consent Form.
  • Has not responded to conservative treatment for a period of 5 months.
  • If of child-bearing potential, subject is non-pregnant (documented by a negative Pregnancy test within 72 hours of surgery), non-nursing female who agrees to use adequate contraception for 16 weeks following surgery

You may not qualify if:

  • Has spinal condition other than symptomatic degenerative disc disease at the involved surgical level.
  • Had previous anterior surgical procedures at the involved spinal level.
  • Has a condition which requires postoperative medications that interfere with fusion such as steroids or nonsteroidal anti-inflammatory drugs. (This does not include low dose aspirin for prophylactic anticoagulation.)
  • Has osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated.
  • Has circulatory problems, such as thrombophlebitis, lymphedema, or vascular deficiency at the implant site.
  • Has symptomatic cardiac disease.
  • Has presence of active malignancy or history of cancer in the past 5 years.
  • Has overt or active infection.
  • Is obese, i.e., weight greater than 40% over ideal for their age and height.
  • Has fever (temperature \> 101°F oral).
  • Has local inflammatory signs indicative of infection.
  • Has a documented metal allergy or intolerance.
  • Is involved in a worker's compensation or unresolved spinal litigation case.
  • Is mentally incompetent (either documented or in the opinion of the investigator).
  • Has psychogenic magnification of pain (in the opinion of the investigator).
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

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

December 12, 2011

First Posted

December 14, 2011

Study Start

January 1, 1997

Primary Completion

September 1, 1999

Study Completion

September 1, 1999

Last Updated

August 2, 2013

Record last verified: 2011-12