Status:
UNKNOWN
Retrospective Foot and Ankle Data Collection
Lead Sponsor:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Conditions:
Lower Limb Surgery
Eligibility:
All Genders
18+ years
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 Reconstruct...
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 fo...
Eligibility Criteria
Inclusion
- 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
- None
Key Trial Info
Start Date :
March 30 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05234801
Start Date
March 30 2022
End Date
July 30 2022
Last Update
May 24 2022
Active Locations (1)
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1
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, United Kingdom, SY10 7AG