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
1 other identifier
observational
300
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2022
CompletedFirst Posted
Study publicly available on registry
February 10, 2022
CompletedStudy Start
First participant enrolled
March 30, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedMay 24, 2022
May 1, 2022
3 months
January 20, 2022
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (3)
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
Patients who received a device from the ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System family of devices during routine lower limb surgery.
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.
Interventions
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.
A multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot.
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.
Eligibility Criteria
Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.
You may qualify if:
- 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.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG, United Kingdom
Study Officials
- STUDY CHAIR
Andrew Bing, FRCS
Robert Jones and Agnes Hunt Orthopaedic Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2022
First Posted
February 10, 2022
Study Start
March 30, 2022
Primary Completion
June 30, 2022
Study Completion
July 30, 2022
Last Updated
May 24, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share
No plan to share the raw retrospective data collected from routine clinical assessments following lower limb surgery.