Retrospective Foot and Ankle Data Collection

• Conditions: Lower Limb Surgery
• Interventions: Device: DARCO™ Headed Cannulated Screw; Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System

• Registration Number: NCT05234801
• Lead Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

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

Study Timeline

• Study First Submitted: 2022-01-20
• Study First Submitted QC: 2022-02-01
• Study First Posted: 2022-02-10
• Study Start: 2022-03-30
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-17
• Last Update Posted: 2022-05-24
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DARCO™ Headed Cannulated Screw	DARCO™ Headed Cannulated Screw	Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery.
ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System	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.

Primary Outcome Measures

Name	Time	Method
To demonstrate the safety of the devices concerned.	3 months	Device related intra and post operative adverse events
To demonstrate the performance of the devices concerned.	1 year.	Device related intra and post operative adverse events

Trial Locations

Locations (1)

The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust; 🇬🇧 Oswestry, Shropshire, United Kingdom