NCT06226272

Clinical Outcome Measure at Stryker Spine

Clinical Outcome Measure at Stryker Spine: COMPASS

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 5,222 (estimated)
• Sponsor: Stryker Spine · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Degenerative Disc Disease
• Degenerative Scoliosis

Interventions

Type	Name	Description
DEVICE	Spinal Fusion	Cervical Spinal Fusion
DEVICE	Spinal Fusion	Thoracic / Lumbar Spinal Fusion
DEVICE	Spinal Deformities Correction	Spinal Deformities Correction

Timeline

• Start date: 2024-05-06
• Primary completion: 2029-01-29
• Completion: 2032-01-29
• First posted: 2024-01-26
• Last updated: 2024-04-16

Regulatory

• FDA-regulated device study