Lower Limb SurgeryNCT05234801
Retrospective Foot and Ankle Data Collection
An observational study of Lower Limb Surgery, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lower Limb Surgery
- What is being tested?
- DARCO™ Headed Cannulated Screw, ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System and ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Mar 2022to 30 Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.
Who may be able to join
- 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.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Robert Jones and Agnes Hunt Orthopaedic Hospital NHS Foundation Trust
Oswestry, Shropshire, SY10 7AG
About this study
Official title: 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
Read the 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
- Conditions
- Lower Limb Surgery
- Being tested
- DARCO™ Headed Cannulated Screw, ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System, ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DARCO™ Headed Cannulated ScrewDevice
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 SystemDevice
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™ ModuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| DARCO™ Headed Cannulated Screw | Patients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery. Receives: Device: DARCO™ Headed Cannulated Screw | |
| 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. Receives: Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System | |
| 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. Receives: Device: ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the performance of the devices concerned.
Device related intra and post operative adverse events
Measured: 1 year.
To demonstrate the safety of the devices concerned.
Device related intra and post operative adverse events
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start30 Mar 2022
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Limb SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Andrew Bing, FRCS, Study chair, Robert Jones and Agnes Hunt Orthopaedic Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234801
- Sponsor's protocol ID
- RL1 849
- Status last verified
- May 2022
- First submitted
- 20 Jan 2022
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share the raw retrospective data collected from routine clinical assessments following lower limb surgery.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05234801
- Acronym / sponsor ID
- RL1 849
- Conditions
- Lower Limb Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Robert Jones and Agnes Hunt Orthopaedic and District NHS TrustOther government
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 10 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DARCO™ Headed Cannulated Screw | – | Device: DARCO™ Headed Cannulated ScrewPatients who received a device from the DARCO™ Headed Cannulated Screw family of devices during routine lower limb surgery. |
| ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System | – | Device: ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot SystemPatients 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 | – | Device: ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ ModulePatients who received a device from the ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module family of devices during routine lower limb surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospective data collection from those who have received the interested devices during lower limb surgery at this single centre.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DARCO™ Headed Cannulated ScrewThe 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. | Device | DARCO™ Headed Cannulated Screw |
| ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot SystemA multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot. | Device | ORTHOLOC™ 3Di Recon-Midfoot/Flatfoot System |
| ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ ModuleA 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. | Device | ORTHOLOCTM 3Di 2 Foot Reconstruction System: CROSSCHECK™ Module |
Primary outcome
To demonstrate the performance of the devices concerned.
Time frame: 1 year.
Device related intra and post operative adverse events
To demonstrate the safety of the devices concerned.
Time frame: 3 months
Device related intra and post operative adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
- Individual participant dataSharing planned: No. No plan to share the raw retrospective data collected from routine clinical assessments following lower limb surgery.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Bing, FRCS study chair
Robert Jones and Agnes Hunt Orthopaedic Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lower Limb Surgery, run by Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate the performance of the devices concerned. (time frame: 1 year.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2022.