Retrospective Foot and Ankle Data Collection

Lower Limb Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05234801
• Other study ID #: RL1 849
• Status: Active, not recruiting
• Start date: March 30, 2022
• Est. completion date: July 30, 2022

Study information

• Verified date: May 2022
• Source: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: July 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Surgery

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
United Kingdom	The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust	Oswestry	Shropshire

Sponsors (1)

Lead Sponsor	Collaborator
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To demonstrate the performance of the devices concerned.	Device related intra and post operative adverse events	1 year.
Primary	To demonstrate the safety of the devices concerned.	Device related intra and post operative adverse events	3 months