Clinical Outcome Measure at Stryker Spine

Not yet recruiting

• Conditions: Degenerative Disc Disease; Degenerative Scoliosis
• Interventions: Device: Spinal Fusion; Device: Spinal Deformities Correction

• Registration Number: NCT06226272
• Lead Sponsor: Stryker Spine

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2024-01-04
• Study First Submitted QC: 2024-01-17
• Study First Posted: 2024-01-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-16
• Study Start: 2024-05-06
• Primary Completion: 2029-01-29
• Study Completion: 2032-01-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 5222

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
S-S-102-A: Cervical Sub-Protocol	Spinal Fusion	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.
S-S-102-C: Adult Spinal Deformities	Spinal Deformities Correction	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.
S-S-102-B: Thoracolumbar Sub-Protocol	Spinal Fusion	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.

Primary Outcome Measures

Name	Time	Method
S-S-102-C	Baseline through 24-months post-op.	Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r).
S-S-102-A	Baseline through 24-months post-op.	Mean change in the subject's Neck Disability Index (NDI) score.
S-S-102-B	Baseline through 24-months post-op.	Mean change in the subject's Oswestry Disability Index (ODI) score.

Secondary Outcome Measures

Name	Time	Method
S-S-102-A	Surgery through 24-months post-op.	The incidence of the following safety events: * Serious Adverse Events (AEs); * Device-related AEs; * Procedure-related AEs; * Operative AEs; * Secondary spine surgeries
S-S-102-B	Surgery through 24-months post-op.	The incidence of the following safety events: * Serious Adverse Events (AEs); * Device-related AEs; * Procedure-related AEs; * Operative AEs; * Secondary spine surgeries
S-S-102-C	Surgery through 24-months post-op.	The incidence of the following safety events: * Serious Adverse Events (AEs); * Device-related AEs; * Procedure-related AEs; * Operative AEs; * Secondary spine surgeries