Ankle InjuriesNCT05190159
Monster Screw System Post-Market Clinical Follow-Up Study
An observational study of Ankle Injuries and Foot Injury, run by Paragon 28 at 1 site in United States.
Trial summary
Post-market clinical follow-up study on the Monster Screw System Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Injuries, Foot Injury
- What is being tested?
- Monster Screw System
- Type of treatment
- Medical device
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2022to 21 Sep 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Who may be able to join
- The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
- The subject has adequate radiographic and medical records
- For the Prospective Data Collection:
- The subject is willing to provide written informed consent
Who cannot join
- -None
Trial locations and contacts
1 site in 1 country.
About this study
Post-market clinical follow-up study on the Monster Screw System
Read the detailed description
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
- Conditions
- Ankle Injuries, Foot Injury
- Being tested
- Monster Screw System
- Medical subject headings
- Ankle Injuries, Foot Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monster Screw SystemDevice
Subjects who have undergone a foot and/or ankle procedure involving the index device
| Study group | Role | What they receive |
|---|---|---|
| Monster Screw System | Not described Receives: Device: Monster Screw System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of secondary procedures
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Measured: Up to 9 months
Incidence of adverse events
Safety will be assessed by recording the incidence of adverse events
Measured: Up to 9 months
Secondary outcomes (6)
Rate of Nonunion
Safety as related to the rate of nonunion of the area treated with the index device
Measured: Up to 9 months
Rate of Maintenance of Correction
Safety as related to the rate of the maintenance of correction
Measured: Up to 9 months
Rate of Index Device Failure
Safety as related to the rate of the failure of the index device
Measured: Up to 9 months
Foot and Ankle Mobility Measure
Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) subscale and current level of daily activity rating (0-100). The higher the score, the higher the level of function, with 100% representing no dysfunction.
Measured: Up to 54 months
Visual Analog Scale
Device performance and benefits as related to pain levels based on the Visual Analog Scale (range: 0 to 100; 0 = no pain; 100 = worst pain imaginable)
Measured: Up to 54 months
Patient satisfaction
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Measured: Up to 54 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2022
- Study start26 Jan 2022
- Primary completion14 Sep 2022
- Study completion21 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankle InjuriesStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paragon 28
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacy Legue, Study director, Paragon 28
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05190159
- Sponsor's protocol ID
- P20-SP-0001
- Status last verified
- Sep 2022
- First submitted
- 20 Dec 2021
- Last updated
- 23 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monster Screw System Post-Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT05190159
- Acronym / sponsor ID
- P20-SP-0001
- Conditions
- Ankle Injuries, Foot Injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 26 Jan 2022 (actual)
- Primary completion
- 14 Sep 2022 (actual)
- Study completion
- 21 Sep 2022 (actual)
- First posted
- 13 Jan 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.
Post-market clinical follow-up study on the Monster Screw System
Detailed description
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Monster Screw System.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Monster Screw System | – | Device: Monster Screw System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigational population will include subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Key inclusion criteria (4 listed)
- The subject has undergone a foot and/or ankle procedure using the Monster Screw System and completed by one of the investigators.
- The subject has adequate radiographic and medical records
- The subject is willing to provide written informed consent
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 |
|---|---|---|
| Monster Screw SystemSubjects who have undergone a foot and/or ankle procedure involving the index device | Device | Monster Screw System |
Primary outcome
Incidence of secondary procedures
Time frame: Up to 9 months
Safety will be assessed by recording the incidence of secondary procedures related to the index procedure
Incidence of adverse events
Time frame: Up to 9 months
Safety will be assessed by recording the incidence of adverse events
6 secondary outcomes
Rate of Nonunion
Time frame: Up to 9 months
Rate of Maintenance of Correction
Time frame: Up to 9 months
Rate of Index Device Failure
Time frame: Up to 9 months
Foot and Ankle Mobility Measure
Time frame: Up to 54 months
Visual Analog Scale
Time frame: Up to 54 months
Patient satisfaction
Time frame: Up to 54 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Jacy Legue study director
Paragon 28
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 Ankle Injuries and Foot Injury, run by Paragon 28 at 1 site in United States.
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 4 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: finished, as of the sponsor's last update on 23 Sep 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 States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence of secondary procedures (time frame: Up to 9 months). 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 23 Sep 2022.