Advanced Materials Science in XLIF Study

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
NuVasive
Study ID
NCT03649490
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Study Details

This study is being conducted to evaluate the clinical and radiographic outcomes of three different interbody implant types when used with cancellous allograft chips with BMA or cellular allograft in patients undergoing XLIF surgery. The study will evaluate success by comparing the rate of fusion, complications profile, and any relationships between clinical outcomes (pain and function) and radiographic outcomes (fusion rate) between the three implant groups.

Key Dates

Start date
Aug 19, 2018
Status verified
Dec 2025
Primary completion
Jun 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Smooth PEEK Interbody Implants in XLIF
    Smooth PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) provide maximum surface area and structural stability with large central apertures to allow bony through-growth. Multiple length options enable optimal apophyseal support, thus reducing the chance of subsidence. Additionally, lordotic profiles are available to induce proper sagittal alignment.
  • Arm: 3D-Printed Titanium Interbody Implants in XLIF
    3D-printed, fully porous titanium interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) have a porous architecture that mimics the porosity and stiffness of bone for reduced stress shielding and improved radiographic imaging. The advanced microporous surface topography creates an ideal environment for bone in-growth.
  • Arm: Porous PEEK Interbody Implants in XLIF
    Porous PEEK interbody implants for XLIF (with allograft chips and BMA or cancellous allograft) combine the osseointegration capabilities of porous metal implants with the favorable imaging and mechanical properties of traditional PEEK implants. The Porous PEEK architecture, with 60% porosity and 300 mm average pore size, is specifically tailored to elicit the optimal osteogenic cell response and promote bone tissue ingrowth inside the pores, as demonstrated in preclinical studies.

Primary Outcome Measure

Radiographic Fusion Success [ Time Frame: 24 months ]

Locations (15)

FacilityCityStateZIPSite coordinators
Hartford Healthcare Bone and Joint InstituteHartfordConnecticut06106-
Lyerly NeurosurgeryJacksonvilleFlorida32207-
University of South Florida Department of Neurosurgery, Tampa General HospitalTampaFlorida33606-
Rush University Medical CenterChicagoIllinois60612-
Orthopaedic Institute of Western KentuckyPaducahKentucky42001-
Suburban Hospital, Johns Hopkins MedicineBethesdaMaryland20814-
University of MinnesotaMinneapolisMinnesota55455-
Columbia Orthopedic Group ResearchColumbiaMissouri65201-
OrthoCarolinaCharlotteNorth Carolina28207-
Duke UniversityDurhamNorth Carolina27710-
Atlantic Brain and SpineWilmingtonNorth Carolina28401-
The Spine Clinic of OKCOklahoma CityOklahoma73114-
UT Health San AntonioSan AntonioTexas78229-
University of Virginia Health SystemCharlottesvilleVirginia22903-
Evergreen HealthKirklandWashington98034-

Find similar trials in Hartford, CT

By research site
Hartford Healthcare Bone and Joint Institute· Hartford, CTLyerly Neurosurgery· Jacksonville, FLUniversity of South Florida Department of Neurosurgery, Tampa General Hospital· Tampa, FLRush University Medical Center· Chicago, ILOrthopaedic Institute of Western Kentucky· Paducah, KYSuburban Hospital, Johns Hopkins Medicine· Bethesda, MD

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