Lower Limb Surgery
Conditions
Brief 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
Interventions
DEVICEDARCO™ 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.
DEVICEORTHOLOC™ 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.
DEVICEORTHOLOCTM 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.
Sponsors
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients 18 years or older at the time of index procedure • Patients who previously received: * the Charlotte™ MUC Screw System in accordance with the indications for use: for fixation of bone fractures or for bone reconstruction. * 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. * 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. * a DARCO™ Headed Cannulated Screw in accordance with the indications for use: for bone fracture fixation and bone fragment fixation.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United Kingdom
Outcome results
None listed