Clinical Outcome Measure at Stryker Spine

Degenerative Disc Disease Clinical Trial

— COMPASS  

Official title:

Clinical Outcome Measure at Stryker Spine: COMPASS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06226272
• Other study ID #: S-S-102
• Status: Not yet recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Degenerative Scoliosis
• Intervertebral Disc Degeneration
• Scoliosis

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.