Retrospective Foot and Ankle Data Collection

NCT ID: NCT05234801

Last Updated: 2022-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-30

Study Completion Date

2022-07-30

Brief Summary

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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

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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

Conditions

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Lower Limb Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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DARCO™ Headed Cannulated Screw

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

DARCO™ Headed Cannulated Screw

Intervention Type DEVICE

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.

ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System

Intervention Type DEVICE

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.

ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Bing, FRCS

Role: STUDY_CHAIR

Robert Jones and Agnes Hunt Orthopaedic Hospital

Locations

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The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust

Oswestry, Shropshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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RL1 849

Identifier Type: -

Identifier Source: org_study_id

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