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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06226272
Other study ID # S-S-102
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date May 6, 2024
Est. completion date January 29, 2032

Study information

Verified date April 2024
Source Stryker Spine
Contact Alyse Borelli
Phone +1 (484) 215-5433
Email alyse.borelli@stryker.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 5222
Est. completion date January 29, 2032
Est. primary completion date January 29, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Spinal Fusion
Cervical Spinal Fusion
Spinal Fusion
Thoracic / Lumbar Spinal Fusion
Spinal Deformities Correction
Spinal Deformities Correction

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Stryker Spine

Outcome

Type Measure Description Time frame Safety issue
Primary S-S-102-A Mean change in the subject's Neck Disability Index (NDI) score. Baseline through 24-months post-op.
Primary S-S-102-B Mean change in the subject's Oswestry Disability Index (ODI) score. Baseline through 24-months post-op.
Primary S-S-102-C Mean change in the subject's Scoliosis Research Society-22 revised (SRS-22r). Baseline through 24-months post-op.
Secondary S-S-102-A The incidence of the following safety events:
Serious Adverse Events (AEs)
Device-related AEs
Procedure-related AEs
Operative AEs
Secondary spine surgeries
Surgery through 24-months post-op.
Secondary S-S-102-B The incidence of the following safety events:
Serious Adverse Events (AEs)
Device-related AEs
Procedure-related AEs
Operative AEs
Secondary spine surgeries
Surgery through 24-months post-op.
Secondary S-S-102-C The incidence of the following safety events:
Serious Adverse Events (AEs)
Device-related AEs
Procedure-related AEs
Operative AEs
Secondary spine surgeries
Surgery through 24-months post-op.
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