NCT01406405

Brief Summary

Purpose The primary purpose of this study is to prospectively compare clinical and radiographic clinical outcomes in patients undergoing cervical or lumbar interbody fusions and randomized to receive either polyetheretherketone (PEEK) or cortical allografts.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

July 1, 2011

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 1, 2011

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 16, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 16, 2018

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

6.9 years

First QC Date

July 27, 2011

Last Update Submit

February 25, 2019

Conditions

Degenerative Disc Disease

Keywords

Degenerative disc diseasespinal stenosisherniated disc

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Scores

    Improvement in the Neck/Arm or Low Back/Leg Visual Analog pain Scale (VAS) scores. A 30% reduction in pain intensity will be considered to be a successful response to treatment.

    24 (+/- 2) months

Secondary Outcomes (1)

  • Clinical and Radiographic Outcomes

    3 (+/-2) weeks and 24 (+/- 2) months

Study Arms (2)

PEEK cages

Patients will have fusion surgery performed using polyetheretherketone (PEEK) cages

Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)

Allograft spacers

Patients will have fusion surgery performed using allograft spacers

Procedure: Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)

Interventions

Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)PROCEDURE

Lumbar or cervical fusion

Allograft spacersPEEK cages

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Boulder Neurosurgical Associates patients

You may qualify if:

  • Skeletally mature adults between 18 and 70 years old
  • Patients with back and leg pain due to degenerative disc disease, scheduled for TLIF/PLIF approach utilizing an interbody spacer and supplemental posterior fixation at 1, 2 or 3 adjacent levels
  • Unresponsive to conservative care over a period of at least 6 months or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
  • Willing and able to comply with the requirements of the protocol including followup requirements
  • Willing and able to sign a study specific informed consent.

You may not qualify if:

  • More than 3 intervertebral levels to be fused
  • Posterior fixation used at more than 1 level for 1-level intervertebral fusion
  • Posterior fixation used at more than 2 levels for 2-level intervertebral fusion
  • Posterior fixation used at more than 3 levels for 3-level intervertebral fusion
  • Any additional approaches, e.g. anterior, XLIF
  • Active local or systemic infection
  • Prior interbody fusion surgery at the index level
  • Prior fusion at the adjacent levels
  • Previous known allergy to polyetheretherketone (PEEK) or titanium alloy
  • Cervical Fusion Patient Group
  • Skeletally mature adults between 18 and 70 years old
  • Patients with neck and/or arm pain due to degenerative disc disease, scheduled for ACDF approach utilizing an interbody spacer and anterior cervical plate at 1, 2 or 3 adjacent levels
  • Completed at least 6 weeks of conservative therapy or has progressive neurological signs and/or symptoms of neurological compromise that mandate urgent surgical intervention
  • Willing and able to comply with the requirements of the protocol including followup requirements
  • Willing and able to sign a study specific informed consent
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boulder Neurosurgical Associates

Boulder, Colorado, 80304, United States

Location

Related Publications (1)

  • Villavicencio AT, Nelson EL, Kantha V, Burneikiene S. Prediction based on preoperative opioid use of clinical outcomes after transforaminal lumbar interbody fusions. J Neurosurg Spine. 2017 Feb;26(2):144-149. doi: 10.3171/2016.7.SPINE16284. Epub 2016 Sep 30.

    PMID: 27689425DERIVED

MeSH Terms

Conditions

Intervertebral Disc DegenerationSpinal StenosisIntervertebral Disc Displacement

Interventions

Gene Fusion

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Recombination, GeneticGenetic Phenomena

Study Officials

  • Alan T Villavicencio, MD

    Boulder Neurosurgical Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 27, 2011

First Posted

August 1, 2011

Study Start

July 1, 2011

Primary Completion

May 16, 2018

Study Completion

May 16, 2018

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(1)