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Clinical and Radiographic Outcomes of Spine Surgeries Utilizing Capri Cervical and Thoracolumbar Corpectomy Cage Systems

NCT05456633 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-09-25

No results posted yet for this study

Summary

This is a retrospective and prospective observational, multi center study of subjects who have undergone or will undergo vertebral body replacement surgery in the cervical or thoracolumbar spine utilizing Stryker Capri Corpectomy Cages.

The primary study hypothesis to determine effectiveness, is that the mean improvement in NDI (cervical) or ODI (thoracolumbar) score from baseline meets or exceeds 15-points at 24 months for Stryker Capri Corpectomy Cage systems individually.

Conditions

  • Thoracolumbar Spine
  • Cervical Spine Injury

Interventions

DEVICE

Capri Cervical Static

When used in the cervical spine (C2-T1), CAPRI Static cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

OTHER

CAPRI Static Expandable

When used in the cervical spine (C2-T1), CAPRI Static Expandable cages are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture, or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.

DEVICE

Capri Thoracolumbar

Intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor and trauma (i.e. fracture).

Sponsors & Collaborators

  • Stryker Spine

    collaborator INDUSTRY

  • K2M, Inc.

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-31
Primary Completion
2024-08-31
Completion
2026-08-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05456633 on ClinicalTrials.gov