Degenerative Disc Disease Clinical Trial
— COMPASSOfficial title:
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).
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Stryker Spine |
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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