Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Fusion | Device | Cervical Spinal Fusion |
| |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| S-S-102-A | The incidence of the following safety events:
| Surgery through 24-months post-op. |
| S-S-102-B |
Not provided
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.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mary Majer | Contact | 866-526-4171 | mary.majer@vbspineco.com | |
| Effa Gyamfi | Contact | 866-526-4171 | effa.gyamfi@vbspineco.com |
| Name | Affiliation | Role |
|---|---|---|
| Jad G. Khalil, MD | Michigan Orthopaedic Surgeons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Recruiting | Jacksonville | Florida | 32224 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013123 | Spinal Fusion |
| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
Not provided
Not provided
| Spinal Fusion |
| Device |
Thoracic / Lumbar Spinal Fusion |
|
| Spinal Deformities Correction | Device | Spinal Deformities Correction |
|
The incidence of the following safety events:
| Surgery through 24-months post-op. |
| S-S-102-C | The incidence of the following safety events:
| Surgery through 24-months post-op. |
| MaineHealth Neurosurgery and Spine | Recruiting | Scarborough | Maine | 04074 | United States |
|
| Michigan Orthopaedic Surgeons | Recruiting | Southfield | Michigan | 48033 | United States |
|
| Cleveland Clinc | Recruiting | Cleveland | Ohio | 44195 | United States |
|
| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
|
| Texas Spine & Scoliosis | Recruiting | Austin | Texas | 78705 | United States |
|
| The University of Texas Health Science Center at Houston | Recruiting | Houston | Texas | 77030 | United States |
|