Cervical Interbody Implant Study

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04689854
• Other study ID #: NUVA.CIB0420
• Status: Enrolling by invitation
• Start date: July 7, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Spinal Instability
• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	Summa Health	Akron	Ohio
United States	University of Virginia	Charlottesville	Virginia
United States	Columbia Orthopedic Group Research	Columbia	Missouri
United States	Duke University	Durham	North Carolina
United States	Hartford Healthcare Bone and Joint Institute	Hartford	Connecticut
United States	Orthopedic Specialty Institute	Orange	California
United States	Mass General Brigham	Somerville	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complications of Interbody Implants	Rate of complications (i.e., safety) attributable to the use of the interbody implants to be studied.	24 months
Primary	Radiographic Fusion Success	The proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative.	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).	Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet MCID (2.5 points and 2.5 points respectively) where 0 is "No Pain" and 10 is "Unbearable Pain".	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the neck disability index.	Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet MCID (7.5 points) where a higher score on the NDI indicates a more severe disability.	24 months
Secondary	Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.	Overall physical and mental health measured by PROMIS-10 will be assessed to determine the percentage of subjects who meet MCID (5 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Secondary	Percentage of subjects meeting Substantial clinical benefit (SCB) as compared to baseline for disability measured by the neck disability index (NDI).	Disability measured by the neck disability index (NDI) will be assessed to determine the percentage of subjects who meet SCB (9.5 points) where a higher score on the NDI indicates a more severe disability.	24 months
Secondary	Percentage of subject meeting Substantial Clinical Benefit (SCB) as compared to baseline for neck/arm pain measured by visual analog scale (VAS).	Neck and arm pain measured using a visual analog scale (VAS) will be assessed to determine the percentage of subjects who meet SCB (3.5 points) where 0 is "No Pain" and 10 is "Unbearable Pain"	24 months
Secondary	Percentage of subjects meeting Substantial Clinical Benefit (SCB) as compared to baseline for measure by overall physical and mental health from PROMIS-10	Overall physical and mental health measured by PROMIS-10 will be assess to determine the percentage of subjects how meet SCB (6.8 points). PROMIS-10 scoring uses a T-score metric in which 50 is the mean of the relevant reference population and 10 is the standard deviation (SD) of that population.	24 months
Secondary	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.	Rate of complications attributable to the use of any additional NuVasive instruments, implants, or technologies.	24 months