Clinical trial NCT04689854: Cervical Interbody Implant Study
Official title: A Prospective, Multicenter Study Evaluating the Safety and Performance of Interbody Implants for the Treatment of Patients with Degenerative Conditions of the Cervical Spine
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Degenerative Disc Disease
Cervical Spinal Instability
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2020-12-30
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Enrolled Population will include all subjects who meet the criteria for enrollment, specifically, those subjects who:

* Satisfied the inclusion and exclusion criteria
* Signed the informed consent
* Underwent the surgical procedure, as defined in this protocol

Subjects not meeting any of these criteria will not be considered enrolled in the study, and therefore not included in any study population or analysis.

Brief summary: The primary objective of this study is to evaluate the safety and performance of cervical spine surgery using interbody implants as measured by reported complications, radiographic outcomes, and patient-reported outcomes (PROs).

Detailed description: This study is a prospective, uncontrolled, multicenter study to evaluate the safety and performance of select interbody implant devices in patients who undergo interbody fusion surgery of the cervical spine. Consecutive patients at a given site who meet eligibility requirements will be asked to consent to participate in the study. These patients will present with degenerative conditions in the cervical spine that are amenable to surgical treatment and will be screened prior to study enrollment. Once enrolled into the study, subjects will undergo interbody fusion surgery using one of the NuVasive interbody implant groups based on the surgeon's standard of care. At least 150 subjects (a minimum of 75 patients in each implant group) will be enrolled and will be followed for 24 months after the surgery.

Eligibility criteria: Inclusion Criteria:

1. Patients who are ≥18 years of age at the time of consent
2. Have a planned spine surgery using interbody implants at one or more cervical levels (C2-T1) for degenerative disc disease and/or cervical spinal instability
3. Using one of the following implants (NuVasive, Inc., San Diego, CA):

   1. Cohere Cervical
   2. Modulus Cervical
4. With interbody fusion using autograft and/or allograft (i.e., cancellous and/or corticocancellous allograft bone) and NuVasive supplemental internal fixation cleared by the applicable regulatory body for use in the cervical spine
5. Able to undergo surgery based on physical exam, medical history, and surgeon judgment
6. Understands the conditions of enrollment, is willing to follow medical advice including postoperative activity restrictions per the surgeon's standard of care, and is willing to sign an informed consent form to participate in the study

Exclusion Criteria:

1. Use of any bone graft that is not cleared by the applicable regulatory body for use within interbody implants. Examples of these include:

   1. Bone morphogenic protein (BMP) (i.e., Infuse (Medtronic))
   2. Synthetic bone graft extenders (e.g., Formagraft (NuVasive), Mastergraft (Medtronic), Vitoss (Stryker), Actifuse (Baxter), nanOss (RTI Surgical), Fibergraft (Prosidyan/Depuy Synthes), and ChronOs (Depuy Synthes))
   3. Demineralized bone matrices (DBM) regulated as medical devices by the FDA (e.g., Grafton Putty/Gel (Medtronic), DBX (MTF/Depuy Synthes), Accell Evo3 (IsoTis), and Propel Putty/Gel (NuVasive))
   4. Peptide enhanced bone graft (e.g., iFactor (Cerapedics))
2. Previous cervical fusion surgery at the level(s) to be treated (adjacent level surgery is acceptable; prior decompression is acceptable)
3. Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
4. Use of bone growth stimulators postoperatively
5. Active smoking within 6 weeks before surgery
6. Patient has known sensitivity to the materials implanted
7. Systemic or local infection (latent or active) or signs of local inflammation
8. Patient has inadequate bone stock or bone quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
9. Patient is a prisoner
10. Patient is participating in another clinical study that would confound study data

Primary outcomes:
measure: Complications of Interbody Implants
timeFrame: 24 months
measure: Radiographic Fusion Success
timeFrame: 24 months
Secondary outcomes:
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.
timeFrame: 24 months
measure: Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.
timeFrame: 24 months
measure: Percentage of subjects meeting Substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index (NDI).
timeFrame: 24 months
measure: Percentage of subject meeting Substantial Clinical Benefit (SCB) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).
timeFrame: 24 months
measure: Percentage of subjects meeting Substantial Clinical Benefit (SCB) as compared to baseline for measure by overall physical and mental health from PROMIS-10
timeFrame: 24 months
measure: Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.
timeFrame: 24 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Orthopedic Specialty Institute
state: California
city: Hartford
country: United States
facility: Hartford Healthcare Bone and Joint Institute
state: Connecticut
city: Somerville
country: United States
facility: Mass General Brigham
state: Massachusetts
city: Columbia
country: United States
facility: Columbia Orthopedic Group Research
state: Missouri
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Akron
country: United States
facility: Summa Health
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Globus Medical
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: