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

NCT05456633 | Withdrawn FDA Device

• 1 other identifier: CAS-031
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Mean improvement in NDI score

  Mean improvement in NDI score over baseline that meets or exceeds 15 points (on a 100 point scale) at 24 months (cervical)

  24 Months

• Mean ODI improvement

  Mean ODI improvement over baseline that meets or exceeds 15 points (on a 100-point scale) at 24 months (thoracolumbar)

  24 Months

Secondary Outcomes (19)

• NDI or ODI

  Initial Post-Op to 24 Months

• Visual Analogue Scale (VAS)

  Initial Post-Op to 24 Months

• EuroQol-5 Dimensions-5 Levels (EQ 5D-5L)

  Initial Post-Op to 24 Months

• Fusion or non-union

  24 Months

• Range of motion

  24 Months

Study Arms (3)

Capri Cervical 3D Static

Subjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders

Device: Capri Cervical Static

Capri Cervical 3D Expendable

Subjects who have undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders

Other: CAPRI Static Expandable

Capri Thoracolumbar Expandable

Subjects who have undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) with Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)

Device: Capri Thoracolumbar

Interventions

Capri Cervical Static DEVICE

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.

Capri Cervical 3D Static

CAPRI Static Expandable OTHER

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.

Capri Cervical 3D Expendable

Capri Thoracolumbar DEVICE

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

Capri Thoracolumbar Expandable

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The sample size for this study will be a total of 126 subjects planned to receive one of the Capri Corpectomy systems mentioned below at up to 20 sites in the United State: * 42 subjects for Capri Cervical 3D Static * 42 subjects for Capri Cervical 3D Expandable * 42 subjects for Capri Thoracolumbar Expandable This sample size allows for up to a 15% loss-to-follow-up at 24 months. The sample size analysis below indicates that N=36 per device are needed for 80% power to meet the a priori performance goal

You may qualify if:

• Skeletally mature
• Willingness and ability to comply with the requirements of the protocol including follow-up requirements
• Willing and able to sign a study specific informed consent form. For fully retrospective enrollments, i.e., subjects that already have 24-month follow-up data available, the Principal Investigator will request a waiver of the written informed consent requirement.
• Has undergone or will undergo VBR in the cervical spine (C2 to T1 in the USA, C3 to C7 outside of the USA) using either Capri Cervical 3D Static OR Capri Cervical 3D Expandable to replace diseased or damaged vertebral bodies due to tumor, trauma (i.e., fracture), or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spine cord and neural tissues in cervical degenerative disorders -OR- Has undergone or will undergo VBR in the thoracolumbar spine (T1 to L5) using Capri Thoracolumbar Expandable to replace collapsed, damaged, or unstable vertebral bodies due to tumor or trauma (i.e., fracture)
• Score at least 30 points on the ODI or at least 30 points on the NDI at screening (or before surgery for retrospective enrollment) (on a 100-point scale)

You may not qualify if:

• Presence of infection, except within the spinal indications for use of this product
• Pregnancy (pregnant at the time of enrollment or intends to become pregnant during the course of the study)
• Metabolic disorders of calcified tissues
• Grossly distorted anatomy
• Inadequate tissue coverage
• Drug / alcohol abuse
• Mental illness such as a psychiatric or cognitive impairment, that in the opinion of the investigator, would interfere with the subject's ability to comply with the study requirements or patient reported outcomes (e.g., Alzheimer's Disease)
• General neurological conditions
• Immunosuppressive disorders
• Subjects with known sensitivities to materials in the device
• Obesity defined as a BMI greater than 30
• Subjects who are unwilling to restrict activities or follow medical advice
• Any condition where the implants interfere with anatomical structures or precludes the benefit of spinal surgery
• Biological factors such as smoking, use of nonsteroidal anti-inflammatory agents, use of anticoagulants, etc.
• Subjects that adhere to the specified washout period detailed below can be enrolled: Smoking cessation must occur at a minimum of 4 weeks prior to surgery; Nonsteroidal anti-inflammatories (NSAIDs) should be stopped at a minimum of 7 days prior to surgery; Anticoagulants should be stopped at the discretion of the operating surgeon as the washout period varies for each medication

Sponsors & Collaborators

• K2M, Inc.: lead
• Stryker Spine: collaborator

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 13, 2022
• Study Start: October 1, 2023
• Primary Completion: August 1, 2024
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 25, 2023

Record last verified: 2023-09