Lumbar Interbody Implant Study

Part of paid clinical trials in La Jolla, California.

Sponsor
NuVasive
Study ID
NCT04418830
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 1, 2020
Status verified
Dec 2025
Primary completion
Dec 31, 2025
Completion
Jul 1, 2026

Study Design

Enrollment
1,050 participants (estimated)

Arms

  • Arm: Base Interfixated System
  • Arm: Brigade Interfixated System
  • Arm: Coalesce Thoracolumbar Interbody
  • Arm: Cohere XLIF Interbody System
  • Arm: CoRoent Ti PLIF Interbody System
  • Arm: CoRoent Ti TLIF Interbody System
  • Arm: MLX - Medial Lateral Expandable Interbody System
  • Arm: Modulus TLIF Interbody System
  • Arm: Modulus XLIF Interbody System
  • Arm: TLX Interbody System
  • Arm: XLX ACR Interbody System
  • Arm: CoRoent Ti XLIF Interbody System
  • Arm: Cohere TLIF
  • Arm: Modulus ALIF

Primary Outcome Measure

Complications of Interbody Implants [ Time Frame: 24 months ]

Locations (16)

FacilityCityStateZIPSite coordinators
University of California San DiegoLa JollaCalifornia92037-
Verma SpineLos AlamitosCalifornia90720-
Valley Spine CareMercedCalifornia95348-
Hoag OrthopedicsOrangeCalifornia92868-
Hartford Healthcare Bone and Joint InstituteHartfordConnecticut06106-
Lyerly NeurosurgeryJacksonvilleFlorida32207-
Northwestern UniversityChicagoIllinois60610-
DuPage Medical GroupNapervilleIllinois60540-
Beaumont Hospital Research InstituteRoyal OakMichigan48073-
Columbia Orthopaedics GroupColumbiaMissouri65201-
Duke UniversityDurhamNorth Carolina27710-
Atlantic Brain and SpineWilmingtonNorth Carolina28401-
Summa HealthAkronOhio44320-
Ohio State UniversityDublinOhio43016-
UPMC PresbyterianPittsburghPennsylvania15213-
University of VirginiaCharlottesvilleVirginia22908-

Find similar trials in La Jolla, CA

By research site
University of California San Diego· La Jolla, CAVerma Spine· Los Alamitos, CAValley Spine Care· Merced, CAHoag Orthopedics· Orange, CAHartford Healthcare Bone and Joint Institute· Hartford, CTLyerly Neurosurgery· Jacksonville, FL

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