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A retrospective post-market data collection study of the following implant devices :
A retrospective post-market data collection study designed to collect safety and performance Standard of Care data on patients who have undergone routine lower limb surgery that involved one of the following implant devices as per the indication for use:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DARCO™ Headed Cannulated Screw | Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery. |
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| ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System | Patients who received a device from the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System family of devices during routine lower limb surgery. |
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| ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module | Patients who received a device from the ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module family of devices during routine lower limb surgery. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DARCO™ Headed Cannulated Screw | Device | The DARCO™ Headed Cannulated Screw is a multi-size screw system designed to be used over a guide pin or wire with instrumentation to provide interfragmentary compression and stability for bone fracture/fragment fixation. |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate the performance of the devices concerned. | Device related intra and post operative adverse events | 1 year. |
| To demonstrate the safety of the devices concerned. | Device related intra and post operative adverse events | 3 months |
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Inclusion Criteria:
Patients 18 years or older at the time of index procedure
• Patients who previously received:
Exclusion Criteria:
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Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Bing, FRCS | Robert Jones and Agnes Hunt Orthopaedic Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | Shropshire | SY10 7AG | United Kingdom |
No plan to share the raw retrospective data collected from routine clinical assessments following lower limb surgery.
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| ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System | Device | A multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot. |
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| ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module | Device | A comprehensive fixation system consisting of a wide variety of plate options, created with the purpose of stabilization and fixation of fractures, revision procedures, joint fusion and reconstruction of small bones of the feet. |
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