ACDF Comparison Trial

Not Applicable

Withdrawn

• Conditions: Cervical Spine Disc Disease; Fusion of Spine; Surgery; Degenerative Disc Disease
• Interventions: Device: Cohere PEEK Fusion Group; Other: Allograft Fusion

• Registration Number: NCT03187171
• Lead Sponsor: Duke University

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.

Detailed Description

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 polyetheretherketone (PEEK) fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.

Pain and function will be assessed using neck disability index (NDI), 36-Item Short Form Survey (SF-36), and Numeric Rating Scale (NRS). A trained study team member will record a standardized neurologic examination, including motor, sensory, and reflexes. Neurologic success is defined as maintenance or improvement of all 3 neurologic parameters (motor, sensory, and reflexes). The clinical results will also be assessed using the Japanese Orthopedic Association (JOA) scoring system for cervical myelopathy.

Flexion and extension radiographs will be obtained pre-operatively, at 6-months and 12-months after surgery. A CT scan will be obtained at 6 months, if fusion has occurred no CT is needed at 12 months, if fusion did not occur another computerized tomography (CT) scan will obtained at 12 months. From previous literature, successful fusion is defined as ≤2° of angular motion on lateral flexion and extension radiographs, the presence of bridging trabecular bone between the vertebrae being fused, and the absence of any radiolucent zones spanning more than 50% of the allograft surface. Two independent blinded radiologists will assess the radiographs. In the event of disagreement about fusion healing, a third independent reading will be obtained from a third radiologist.

Study Timeline

• Study First Submitted: 2017-06-12
• Study First Submitted QC: 2017-06-12
• Study First Posted: 2017-06-14
• Study Start: 2018-12-01
• Primary Completion: 2019-04-23
• Study Completion: 2019-04-23
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-09
• Last Update Posted: 2019-05-13

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. 18 or more years of age
2. Able to provide informed consent
3. Has documented diagnosis of cervical spine radiculopathy and/or myelopathy
4. Is undergoing standard-of-care ACDF

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohere PEEK Fusion Group	Cohere PEEK Fusion Group	The anterior approach to the cervical spine for discectomy and fusion by the insertion of a Cohere porous PEEK fusion device.
Allograft Fusion Group	Allograft Fusion	The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft.

Primary Outcome Measures

Name	Time	Method
Rate of successful fusion.	18 months	To compare post-operative bone fusion following standard-of-care ACDF using allograft fusion or Cohere porous PEEK fusion.

Secondary Outcome Measures

Name	Time	Method
Overall success rate - composite score.	18 months	To be considered an overall success, patients have to achieve all of the following: a ≥15 point improvement in their NDI scores, maintenance or improvement in their neurologic status, no serious adverse events related to the implant or surgical procedure, and no subsequent surgery or intervention that is classified as "failure."