Clinical trial NCT03187171: ACDF Comparison Trial
Official title: Comparison of Outcomes After ACDF Using Allograft Fusion Versus PEEK Fusion: a Prospective Clinical Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cervical Spine Disc Disease
Surgery
Fusion of Spine
Degenerative Disc Disease
Keywords: Anterior Cervical Spine Fusion
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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 PEEK fusion group and will be followed for approximately 12 months following surgery according to the standard-of-care.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

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.

Primary outcomes:
measure: Rate of successful fusion.
timeFrame: 18 months
Secondary outcomes:
measure: Overall success rate - composite score.
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
affiliation: Duke University
name: Michael Haglund, MD
role: PRINCIPAL_INVESTIGATOR
References: