NCT03028402

Brief Summary

This study aims to determine to what extent patient-specific factors, iatrogenic factors, and biomechanical factors influence cervical spine mechanics after single-level and two-level arthrodesis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2016

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

First Submitted

Initial submission to the registry

February 10, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
10 months until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

February 6, 2025

Status Verified

September 1, 2024

Enrollment Period

8.8 years

First QC Date

February 10, 2016

Last Update Submit

February 3, 2025

Conditions

Intervertebral Disc Degeneration

Outcome Measures

Primary Outcomes (6)

  • Kinematics

    range of motion (ROM) in degrees

    pre-surgery to 3 years post-surgery

  • Iatrogenic factors

    adjacent segment disc height and sagittal alignment; graft height, plate placement

    pre-surgery to 3 years post-surgery

  • Kinematics

    The helical axis of motion (HAM)

    pre-surgery to 3 years post-surgery

  • Kinematics

    The continuous 3D intervertebral kinematics (translations and rotations).

    pre-surgery to 3 years post-surgery

  • Arthrokinematics

    Disc deformation

    pre-surgery to 3 years post-surgery

  • Arthrokinematics

    Facet joint capsule deformation

    pre-surgery to 3 years post-surgery

Study Arms (5)

Asymptomatic Controls

Individuals who have no history of neck pain, trauma or surgery, similar in age and sex to the surgical patients

C5-C6 arthrodesis

Patients scheduled to undergo C5-C6 anterior cervical arthrodesis

Procedure: C5-C6 arthrodesis

C6-C7 arthrodesis

Patients scheduled to undergo C6-C7 anterior cervical arthrodesis

Procedure: C5-C6 arthrodesis

C4-C5-C6 arthrodesis

Patients scheduled to undergo C4-C5-C6 anterior cervical arthrodesis

Procedure: C5-C6 arthrodesis

C5-C6-C7 arthrodesis

Patients scheduled to undergo C5-C6-C7 anterior cervical arthrodesis

Procedure: C5-C6 arthrodesis

Interventions

C5-C6 arthrodesisPROCEDURE

A standard Smith Robinson anterior medial approach to the cervical spine. Vertebral endplates will be prepared by removing the cartilage endplate. Tricortical anterior iliac crest autografts will be harvested with a low-speed oscillating saw. Allografts will be fresh-frozen, vacuum-sealed, nonradiated tricortical grafts. All grafts will be fashioned in a typical Smith-Robinson formation. The motion segment will be distracted approximately 2-mm beyond the graft height before the insertion of each graft. Fusion plate will be contoured to cervical lordosis. Cervical plates will be positioned using surgical midline markers. All rigid anterior plate fixations will be performed using titanium anterior fixed-angle screw systems.

C4-C5-C6 arthrodesisC5-C6 arthrodesisC5-C6-C7 arthrodesisC6-C7 arthrodesis

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

All patients will be between 21 and 60 years of age and will be scheduled to undergo single-level or two-level anterior cervical discectomy and fusion (ACDF) at the C56, C67, C456 or C567 levels. Indications for surgical intervention will be progressive symptoms refractory to conservative treatment for myelopathy, radiculopathy, or myeloradiculopathy resulting from degenerative spondylosis, symptomatic cervical disc herniation, or symptomatic disc degeneration.

You may qualify if:

  • Patients must agree to return for all follow-up visits and provide informed consent.
  • Control subjects will be asymptomatic, with no injury or disease that will interfere with spine function, such as previous spine surgery or trauma.

You may not qualify if:

  • Participants will have no other injury or disease that will interfere with spine function, such as previous spine surgery or trauma
  • Individuals who have been previously clinically diagnosed with poor bone quality and those who do not intend to stay in the Pittsburgh area for a period of at least 3 years post-surgery will be excluded.
  • Females who are pregnant or plan to be pregnant within 3 years of surgery will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh Biodynamics Lab

Pittsburgh, Pennsylvania, 15203, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Officials

  • William Anderst, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 10, 2016

First Posted

January 23, 2017

Study Start

April 1, 2016

Primary Completion

December 30, 2024

Study Completion

December 30, 2024

Last Updated

February 6, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)