Retrospective Foot and Ankle Data Collection
Study Details
Study Description
Brief Summary
A retrospective post-market data collection study of the following implant devices :
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DARCO™ Headed Cannulated Screw
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ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
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ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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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DARCO™ Headed Cannulated Screw
-
ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
-
ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| DARCO™ Headed Cannulated Screw Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery. |
Device: DARCO™ Headed Cannulated Screw
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.
|
| 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. |
Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System
A multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot.
|
| 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. |
Device: ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
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.
|
Outcome Measures
Primary Outcome Measures
- To demonstrate the performance of the devices concerned. [1 year.]
Device related intra and post operative adverse events
- To demonstrate the safety of the devices concerned. [3 months]
Device related intra and post operative adverse events
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients 18 years or older at the time of index procedure
• Patients who previously received:
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the Charlotte™ MUC Screw System in accordance with the indications for use: for fixation of bone fractures or for bone reconstruction.
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the CROSSCHECKTM in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
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the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System in accordance with the indications for use: Stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the feet.
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a DARCO™ Headed Cannulated Screw in accordance with the indications for use: for bone fracture fixation and bone fragment fixation.
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust | Oswestry | Shropshire | United Kingdom | SY10 7AG |
Sponsors and Collaborators
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Investigators
- Study Chair: Andrew Bing, FRCS, Robert Jones and Agnes Hunt Orthopaedic Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RL1 849