ACDF Comparison Trial

NCT03187171 | Withdrawn FDA Device

• 1 other identifier: Pro00083342
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research protocol seeks to compare radiological and clinical outcomes of cervical spine disease patients following standard-of-care anterior cervical discectomy and fusion (ACDF) using allograft fusion versus Cohere porous polyetheretherketone (PEEK) fusion device. This clinical study presents little to no additional risk to study subjects beyond those associated with standard-of-care ACDF surgery. Adults age 18 and over who are undergoing an ACDF procedure will be enrolled in the study. The study consists of a completing a series of questionnaires and obtaining radiographs. The primary endpoint of the study will be the rate of successful spinal fusion for each group. For evaluation of the primary endpoint and additional assessments, descriptive statistics including mean, standard deviation, minimum, median, and maximum for continuous variables and frequency distribution for categorical variables will be provided, as well as tabular listings. All complications will be itemized including incidence, duration, and relationship to the device used and/or procedures performed.

Conditions

Cervical Spine Disc Disease; Surgery; Fusion of Spine; Degenerative Disc Disease

Keywords

Anterior Cervical Spine Fusion

Outcome Measures

Primary Outcomes (1)

• Rate of successful fusion.

  To compare post-operative bone fusion following standard-of-care ACDF using allograft fusion or Cohere porous PEEK fusion.

  18 months

Secondary Outcomes (1)

• Overall success rate - composite score.

  18 months

Study Arms (2)

Allograft Fusion Group

ACTIVE COMPARATOR

The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft.

Other: Allograft Fusion

Cohere PEEK Fusion Group

ACTIVE COMPARATOR

The anterior approach to the cervical spine for discectomy and fusion by the insertion of a Cohere porous PEEK fusion device.

Device: Cohere PEEK Fusion Group

Interventions

Allograft Fusion OTHER

ACDF is a surgical technique used to treat a variety of cervical spine disorders, such as nerve root or spinal cord compression, cervical spondylosis, and cervical spinal stenosis. The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft was first described by Robinson and Smith in 1955. In 1958, Cloward described a wide anterior cylindrical discectomy performed with a special reamer combined with anterior fusion by the insertion of autologous iliac bone graft of the same shape. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.

Allograft Fusion Group

Cohere PEEK Fusion Group DEVICE

Bagby et al. developed the first interbody fusion cage. Cages of different shapes and materials are used to perform ACDF which, in some cases, could be associated with plate fixation. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.

Also known as: Fusion Device, PEEK Cage

Cohere PEEK Fusion Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• or more years of age
• Able to provide informed consent
• Has documented diagnosis of cervical spine radiculopathy and/or myelopathy
• Is undergoing standard-of-care ACDF

You may not qualify if:

• Prior cervical spine surgery
• Single-level ACDF
• Has a systemic infection or cervical spine infection
• Has a medical condition that may interfere with bone and soft tissue healing
• Any condition that, in the opinion of the investigator, may preclude accurate data collection or evaluation.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael Haglund, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: This is a prospective randomized comparative outcomes study, in which all subjects who fit the inclusion and exclusion criteria and who agreed to be part of the study will be randomized to either Allograft or Cohere PEEK fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 14, 2017
• Study Start: December 1, 2018
• Primary Completion: April 23, 2019
• Study Completion: April 23, 2019
• Last Updated: May 13, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share