Retrospective Foot and Ankle Data Collection

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust300 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

300

Conditions

Lower Limb Surgery

Interventions

DARCO™ Headed Cannulated ScrewDEVICE

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 SystemDEVICE

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™ ModuleDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

Outcomes

Primary Outcomes

To demonstrate the performance of the devices concerned.

Device related intra and post operative adverse events

Time frame: 1 year.

To demonstrate the safety of the devices concerned.

Device related intra and post operative adverse events

Time frame: 3 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.