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Requested by surgeons to pursue new study
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As a registry, the primary objective of the study is a data collection initiative. The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. The secondary objective is to collect clinical and radiographic outcomes of patients with Medicrea hardware as a control cohort to the patient-specific rods.
The registry will follow the patient during their standard of care visits. At each visit, the patient will answer questions about themselves and also fill out patient reported outcome sheets. Spinopelvic measurements will be obtained on the x-rays taken. This registry is observational only, and there is no driving hypothesis for data collection. Some broad topics of discussion are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgical with Rod | The patient is being treated with the patient specific rod with a surgery date planned |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient Specific Rod | Device | Posterior spinal fusion rod |
|
| Measure | Description | Time Frame |
|---|---|---|
| Data collection initiative | The study will collect clinical and radiographic outcomes of patients implanted with Medicrea's PSR. | Up to 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| Collect clinical and radiographic outcomes of patients with Medicrea hardware | A control cohort to the patient-specific rods | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patient is being implanted with patient specific rod
Only aggregate data will be shared with the other investigators in the group
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D055959 | Intervertebral Disc Degeneration |
| D013130 | Spinal Stenosis |
| D012544 | Scheuermann Disease |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| D055035 |
| Spinal Osteochondrosis |
| D055034 | Osteochondrosis |
| D007738 | Kyphosis |