Retrospective Foot and Ankle Data Collection

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Lower Limb Surgery
• Intervention / Treatment: Device: DARCO™ Headed Cannulated Screw; Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System; Device: 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 Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• United Kingdom
  • Shropshire
    • Oswestry, Shropshire, United Kingdom, SY10 7AG
      • The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DARCO™ Headed Cannulated Screw; Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery.	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; Patients who received a device from the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System family of devices during routine lower limb surgery.	Device: 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; Patients who received a device from the ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module family of devices during routine lower limb surgery.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To demonstrate the performance of the devices concerned.	Device related intra and post operative adverse events	1 year.
To demonstrate the safety of the devices concerned.	Device related intra and post operative adverse events	3 months

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Investigators: Study Chair: Andrew Bing, FRCS, Robert Jones and Agnes Hunt Orthopaedic hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 30, 2022
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): July 30, 2022

Study Registration Dates

• First Submitted: January 20, 2022
• First Submitted That Met QC Criteria: February 1, 2022
• First Posted (ACTUAL): February 10, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 17, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RL1 849

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No plan to share the raw retrospective data collected from routine clinical assessments following lower limb surgery.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No