Clinical Outcome Measure at Stryker Spine

NCT ID: NCT06226272

Last Updated: 2024-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

5222 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-06

Study Completion Date

2032-01-29

Brief Summary

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This is a multicenter, prospective, retrospective, Post Market Clinical Follow-up (PMCF) study in subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared Instructions for Use (IFU).

Detailed Description

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Stryker Spine has a broad portfolio of spinal devices used to stabilize the spine. This PMCF study is designed to collect data on the performance and safety of the devices over their lifetime of 24 months post-implantation. Four protocols have been designed to aid in this process, a master and three sub-protocols. The sub-protocols are based on body region and indication:

* S-S-102-A Cervical: Interbody Devices (IBDs), Vertebral Body Replacement Devices (VBRs), Internal Fixation Devices, and Vitoss
* S-S-102-B Thoracolumbar: IBDs, VBRs, Internal Fixation Devices, and Vitoss
* S-S-102-C Adult Spinal Deformities: IBDs, Internal Fixation Devices, and Vitoss Each of the sub-protocols has its own specific performance endpoint and hypothesis, radiographical data assessments, and SAPs. Safety data will be collected throughout the study.

Conditions

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Degenerative Disc Disease Degenerative Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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S-S-102-A: Cervical Sub-Protocol

The study population includes subjects who are surgically treated with a Stryker device for a cervical condition per the specific device cleared IFUs and Surgical Technique Guides (STGs), by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.

Spinal Fusion

Intervention Type DEVICE

Cervical Spinal Fusion

S-S-102-B: Thoracolumbar Sub-Protocol

The study population includes subjects who are surgically treated with a Stryker device for a thoracic/lumbar condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.

Spinal Fusion

Intervention Type DEVICE

Thoracic / Lumbar Spinal Fusion

S-S-102-C: Adult Spinal Deformities

The study population includes subjects who are surgically treated with a Stryker device for a spinal deformity condition per the specific device cleared IFUs and STGs, by a participating investigator and are willing to complete patient-reported questionnaires at the study-specific time points.

Spinal Deformities Correction

Intervention Type DEVICE

Spinal Deformities Correction

Interventions

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Spinal Fusion

Cervical Spinal Fusion

Intervention Type DEVICE

Spinal Fusion

Thoracic / Lumbar Spinal Fusion

Intervention Type DEVICE

Spinal Deformities Correction

Spinal Deformities Correction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria:

• To be eligible to participate in the study, the potential subject must meet all inclusion criteria specific to the Stryker system being evaluated, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.

Exclusion Criteria:

• The exclusion criteria are based on the contraindications as presented in the Stryker device cleared IFUs, please contact one of the participating investigators or see the device-specific cleared IFU, for further details.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stryker Spine

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Alyse Borelli

Role: CONTACT

+1 (484) 215-5433

Christine Youssif

Role: CONTACT

+1 (551) 276-3028

Other Identifiers

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S-S-102

Identifier Type: -

Identifier Source: org_study_id

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