UnknownNot Applicable

Retrospective Foot and Ankle Data Collection

United Kingdom300 participantsStarted 2022-03-30

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To demonstrate the performance of the devices concerned.

Timeframe: 1 year.

To demonstrate the safety of the devices concerned.

Timeframe: 3 months

Trial details

NCT IDNCT05234801

SponsorRobert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2022-06-30

View on ClinicalTrials.gov More Lower Limb Surgery trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.