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Lumbar Interbody Implant Study

StatusEnrolling by Invitation
PhaseNot specified
SponsorNuVasive
Started
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Record status
This record was last updated December 22, 2025 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Dec 1, 2024 to Dec 31, 2025
    • Study completion date: Dec 1, 2024 to Jul 1, 2026
    v11
  2. 2 versions Re-verified since May 2, 2024, no change to tracked fieldsv9-v10
  3. Study sites: 15 to 16v8
  4. Study sites: 13 to 15v7
  5. Study sites: 11 to 13v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 10 to 11
    • Eligibility criteria expanded, about 22 words
    v5
  2. Study sites revised (10)v4
  3. Trial status: Not Yet Recruiting to Enrolling by Invitationv3 Show 5 more changesShow less
    • Enrollment target: 900 to 1050
    • Study sites: 1 to 10
    • Eligibility criteria expanded, about 46 words
    • Study description revised
    • Study arms: 12 to 14
  4. Start date: Aug 1, 2020 to Oct 1, 2020
    • Study sites: 0 to 1
    • Primary and study completion dates: Oct 1, 2024 to Dec 1, 2024
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
NuVasive
13 trials monitored
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The objective of this study is to evaluate the safety and performance of NuVasive interbody implants when used during thoracic and/or lumbar spine surgery as measured by reported complications, radiographic outcomes, and patient-reported outcomes. This study is being undertaken to identify possible residual risks and to clarify mid- to long-term clinical performance that may affect the benefit/risk ratios of these interbody implants.
Trial Details
NCT Number NCT04418830
Lead Sponsor NuVasive
Conditions
(from sponsor)		 Degenerative Disc Disease, Degenerative Spondylolisthesis, Degenerative Scoliosis, Spinal Stenosis, Sagittal Deformity
Related terms Intervertebral Disc Degeneration, Spinal Stenosis
Enrollment 1,050 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov