Trials / Unknown
UnknownNCT05234801
Retrospective Foot and Ankle Data Collection
A Retrospective Data Collection Study of the Internal Fixation and Reconstruction of Bones in the Foot & Ankle Using Various Devices: DARCO Heads; CROSS CHECK 3Di; OrthoLoc 3Di
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 300 (estimated)
- Sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust · Other Government
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
A retrospective post-market data collection study of the following implant devices : * DARCO™ Headed Cannulated Screw * ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System * ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
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: * DARCO™ Headed Cannulated Screw * ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System * ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Timeline
- Start date
- 2022-03-30
- Primary completion
- 2022-06-30
- Completion
- 2022-07-30
- First posted
- 2022-02-10
- Last updated
- 2022-05-24
Locations
1 site across 1 country: United Kingdom
Source: ClinicalTrials.gov record NCT05234801. Inclusion in this directory is not an endorsement.