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| Name | Class |
|---|---|
| MCRA | INDUSTRY |
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A hybrid prospective/retrospective, multicenter, single-arm, data collection study.
Collect long-term follow-up data with x-rays and CT on subjects who received the DIAMâ„¢ Spinal Stabilization System through the original IDE protocol.
Data collected at one-time point from subjects with at least 5 years of follow-up data.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects historically treated with DIAM | Subjects randomized to the DIAM arm and treated with the DIAMâ„¢ Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAMâ„¢ Spinal Stabilization System in the IDE study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observational | Other | This is an observational study of long term follow up data for patients who previously received the DIAM implant |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety associated with the use of the investigational implant during long term follow up | The DIAM device, specifically at long-term follow-up. A subject is considered to be a long-term success if they are free from serious device-related adverse events through final follow-up. Secondary surgical intervention for treatment failure (i.e. recurrence of pain or functional impairment) without other serious device-related adverse event is not considered to be a serious device-related adverse event for the purposes of the primary endpoint. | 5-10 years after implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Back Pain evaluation | Composite overall success consisting of: Pain/disability (Oswestry) success (≥15 pt. improvement relative to baseline) No serious adverse event is classified as "implant-associated", "procedure associated" or "implant-/surgical procedure associated." No additional surgical procedure at the involved level is classified as a failure. | 5-10 years after implantation |
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Inclusion Criteria:
Exclusion Criteria:
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Data will be collected from up to 8 sites that participated in the DIAM Pivotal Study.
There is no randomization for this study. The goal is to collect long-term follow-up data on patients who participated in the DIAMâ„¢Spinal Stabilization System - Pivotal Study and were randomized to the DIAM arm or who were randomized to the control arm AND crossed over to receive DIAM treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sherif S Elsherif | Contact | 202.552.5893 | ssamy@mcra.com |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D057832 | Watchful Waiting |
| ID | Term |
|---|---|
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Back Pain evaluation | Change in back pain score compared to baseline | 5-10 years after implantation |
| Back Pain evaluation | Back pain success calculated as: Pre-treatment Score - Post-treatment Score > 0 (Score = pain intensity + pain frequency) | 5-10 years after implantation |
| Back Pain evaluation | SF-36/RAND-36 success calculated by: PCSPost-tx - PCSPre-tx > 0 | 5-10 years after implantation |
| D013568 |
| Pathological Conditions, Signs and Symptoms |