XLIF Decade Plate System Study

NCT04689880 | Completed

• 1 other identifier: NUVA.DEC0820
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to evaluate the safety and performance of the NuVasive XLIF Decade Plate System as measured by patient-reported outcomes (PROs), radiographic outcomes, and reported complications.

Conditions

Degenerative Disc Disease; Degenerative Spondylolisthesis; Degenerative Scoliosis

Outcome Measures

Primary Outcomes (2)

• Complication of interbody implant

  Rate of device-related complications (i.e., safety) attributable to the use of the Decade Plate System

  24 months

• Radiographic fusion success

  Proportion of subjects with apparent radiographic fusion (i.e., performance) of the index surgical level(s) at 24 months postoperative

  24 months

Secondary Outcomes (7)

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for back/leg pain measured by visual analog scale (VAS).

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline for disability measured by the Oswestry disability index.

  24 months

• Percentage of subjects meeting minimal clinically important difference (MCID) as compared to baseline measured by overall physical and mental health from PROMIS-10.

  24 months

• Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for back/leg pain measured by visual analog scale (VAS).

  24 months

• Percentage of subjects meeting substantial clinical benefit (SCB) as compared to baseline for disability measured by the Oswestry disability index.

  24 months

Study Arms (1)

XLIF Decade Plate

Eligibility Criteria

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

You may qualify if:

• Patients who are ≥18 years of age at the time of consent
• Planned interbody fusion surgery using the Decade Plate System in conjunction with an interbody implant to treat one or two levels in the thoracic and/or lumbar spine for
• degenerative disc disease
• spondylolisthesis
• scoliosis, kyphosis, lordosis
• spinal stenosis
• spondylolysis
• pseudoarthrosis or failed previous spine surgery
• Able to undergo surgery based on physical exam, medical history, and surgeon judgment
• 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

You may not qualify if:

• Use of posterior fixation for the scheduled surgery Note: Should the surgical plan change intraoperatively and posterior fixation is used in the case, the participant will be withdrawn from the study
• Patient is involved in active litigation relating to the spine (worker's compensation claim is allowed if it is not contested)
• Use of bone growth stimulators postoperatively
• Active smoking within 6 weeks before surgery
• Patient has known sensitivity to materials implanted
• Systemic or local infection (latent or active) or signs of local inflammation
• Patient has inadequate bone stock or quality, or a physical or medical condition that would prohibit beneficial surgical outcome based on surgeon judgment
• Pregnant, or plans to become pregnant during the study
• Patient is a prisoner
• Patient is participating in another clinical study that would confound study data

Sponsors & Collaborators

• NuVasive: lead

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Kyle Malone, MS

  NuVasive

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: December 30, 2020
• Study Start: April 12, 2021
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)