Clinical Outcome Measure at Stryker Spine (COMPASS)

Clinical Outcome Measure at Stryker Spine: COMPASS

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Degenerative Disc Disease; Degenerative Scoliosis
• Intervention / Treatment: Device: Spinal Fusion; Device: Spinal Fusion; Device: Spinal Deformities Correction

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 Type: Observational
• Enrollment (Estimated): 5222

Contacts and Locations

• Study Contact: Name: Alyse Borelli; Phone Number: +1 (484) 215-5433; Email: alyse.borelli@stryker.com
• Study Contact Backup: Name: Christine Youssif; Phone Number: +1 (551) 276-3028; Email: christine.youssif@stryker.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population includes subjects who have undergone or will undergo surgery utilizing one or more Stryker devices according to Stryker cleared IFUs and Surgical Technique Guides (STGs) by a participating investigator and are willing to complete the following patient-reported outcome measures (PROMs) at the study-specific time points.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Spinal Fusion; Cervical Spinal Fusion; Device: Spinal Fusion; Thoracic / Lumbar 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.	Device: Spinal Fusion; Cervical Spinal Fusion; Device: Spinal Fusion; 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.	Device: Spinal Deformities Correction; Spinal Deformities Correction

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Stryker Spine

Study record dates

Study Major Dates

• Study Start (Estimated): May 6, 2024
• Primary Completion (Estimated): January 29, 2029
• Study Completion (Estimated): January 29, 2032

Study Registration Dates

• First Submitted: January 4, 2024
• First Submitted That Met QC Criteria: January 17, 2024
• First Posted (Actual): January 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Device: Cervical or Thoracolumbar Spinal fusion; Device: Adult Spinal Deformities
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis; Intervertebral Disc Degeneration
• Other Study ID Numbers: S-S-102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No