Clinical Outcome Measure at Stryker Spine (COMPASS)

Stryker

Status: Not yet enrolling

Conditions: Degenerative Disc Disease; Degenerative Scoliosis

Treatments: Device: Spinal Deformities Correction; Device: Spinal Fusion

Study type: Observational

Funder types: Industry

Identifiers

NCT06226272

S-S-102

Details and patient eligibility

About

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).

Full 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.

Enrollment: 5,222 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

5,222 participants in 3 patient groups

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

Description:

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.

Treatment:

Device: Spinal Fusion

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

Description:

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.

Treatment:

Device: Spinal Fusion

S-S-102-C: Adult Spinal Deformities

Description:

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.

Treatment:

Device: Spinal Deformities Correction