Posterior Cervical Fixation Study

Part of paid clinical trials in Orange, California.

Sponsor
NuVasive
Study ID
NCT04770571
Status
Enrolling By Invitation

Conditions

  • Cervical Disc Disease
  • Cervical Fusion
  • Cervical Instabilities Spine
  • Cervical Myelopathy
  • Cervical Radiculopathy
  • Cervical Spine Disease
  • Craniocervical Injuries
  • Degenerative Disc Disease
  • Thoracic Injury

Eligibility Criteria

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

Interventions

  • observational study — DEVICE
    observational

Study Details

The objective of this study is to evaluate the safety and performance of occipito-cervico-thoracic spine surgery using posterior fixation as measured by reported complications, radiographic outcomes, and patients reported outcomes (PROs).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 ratio of posterior fixation systems.

Key Dates

Start date
May 10, 2022
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Nov 30, 2028

Study Design

Enrollment
150 participants (estimated)

Arms

  • Arm: Vuepoint II OCT
  • Arm: Reline-C

Primary Outcome Measure

Complications of Posterior Fixation System [ Time Frame: 24 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
UC Irvine Medical CenterOrangeCalifornia92868-
Hartford Healthcare Bone & Joint InstituteHartfordConnecticut06106-
MedStar Health Research InstituteHyattsvilleMaryland20782-
NY Spine InstituteNew YorkNew York10003-
University of Pittsburgh Medical Center (UPMC)PittsburghPennsylvania15213-
Vanderbilt University Medical CenterNashvilleTennessee37232-
Houston MethodistHoustonTexas77030-

Find similar trials in Orange, CA

By research site
UC Irvine Medical Center· Orange, CAHartford Healthcare Bone & Joint Institute· Hartford, CTMedStar Health Research Institute· Hyattsville, MDNY Spine Institute· New York, NYUniversity of Pittsburgh Medical Center (UPMC)· Pittsburgh, PAVanderbilt University Medical Center· Nashville, TN

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