Retrospective Foot and Ankle Data Collection

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Status: Unknown

Conditions: Lower Limb Surgery

Treatments: Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System; Device: ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module; Device: DARCO™ Headed Cannulated Screw

Study type: Observational

Funder types: Other

Identifiers

NCT05234801

RL1 849

Details and patient eligibility

About

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

Full 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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

DARCO™ Headed Cannulated Screw

Description:

Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery.

Treatment:

Device: DARCO™ Headed Cannulated Screw

ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System

Description:

Patients who received a device from the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System family of devices during routine lower limb surgery.

Treatment:

Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System

ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

Description:

Patients who received a device from the ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module family of devices during routine lower limb surgery.

Treatment:

Device: ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module