Ankle InjuriesNCT05190874
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
An observational study of Ankle Injuries and Syndesmotic Injuries, run by Paragon 28 at 1 site in United States.
Trial summary
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain
- What is being tested?
- Grappler Interference Screw System
- Type of treatment
- Medical device
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2022to 6 Apr 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 a minimum of 23 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Who may be able to join
- The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
- The subject signs a written informed consent form (ICF)
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
Read the detailed description
This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain, Achilles Tendon Rupture, Flexor Hallucis Longus on the Left
- Being tested
- Grappler Interference Screw System
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grappler Interference Screw SystemDevice
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
| Study group | Role | What they receive |
|---|---|---|
| Device: Grappler Interference Screw System | Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System Receives: Device: Grappler Interference Screw System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device performance and benefits as related to Foot and Ankle Mobility Measure
Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
Measured: 6 months post-operative
Device performance and benefits as related to pain levels based on the 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)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
Measured: 6 months post-operative
Device performance and benefits as related to pain levels based on Patient satisfaction
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
Measured: 6 months post-operative
Secondary outcomes (1)
Safety will be assessed by recording the incidence of secondary procedures related to the index device
Safety will be assessed by recording the incidence of secondary procedures related to the index device
Measured: 6 months post-operative
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 start14 Jan 2022
- Primary completion11 Mar 2022
- Study completion6 Apr 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
- Other
- Enrolment
- 19 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
- NCT05190874
- Sponsor's protocol ID
- P41-SP-0002
- Status last verified
- Apr 2022
- First submitted
- 29 Dec 2021
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- 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 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
- ClinicalTrials.gov ID
- NCT05190874
- Acronym / sponsor ID
- P41-SP-0002
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain, Achilles Tendon Rupture, Flexor Hallucis Longus on the Left
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 6 Apr 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.
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
Detailed description
This is an ambispective, multi-surgeon, single site, consecutive case series taking place in the United States. Once a subject is identified and informed consent is obtained from that subject, retrospective data will be collected from the subject's electronic medical record (EMR), and prospective data will be collected from subject-provided PROM's. A minimum of 16 and maximum of 23 subjects will participate in the study.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device: Grappler Interference Screw System | – | Device: Grappler Interference Screw SystemFoot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The investigational population will include a minimum of 23 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Key inclusion criteria (2 listed)
- The subject underwent a foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler Interference Screw System and completed by one of the designated investigators who are experienced in the use of such implants and the required specialized surgical techniques
- The subject signs a written informed consent form (ICF)
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 |
|---|---|---|
| Grappler Interference Screw SystemFoot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System | Device | Device: Grappler Interference Screw System |
Primary outcome
Device performance and benefits as related to Foot and Ankle Mobility Measure
Time frame: 6 months post-operative
Device performance and benefits as related to Foot and Ankle Mobility Measure Activities of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
Device performance and benefits as related to pain levels based on the Visual Analog Scale
Time frame: 6 months post-operative
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)of Daily Living (0-84) and sports (0-32) subscales. The higher the score, the higher the level of function, with 100% representing no dysfunction.
Device performance and benefits as related to pain levels based on Patient satisfaction
Time frame: 6 months post-operative
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
1 secondary outcome
Safety will be assessed by recording the incidence of secondary procedures related to the index device
Time frame: 6 months post-operative
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 7 Apr 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 Syndesmotic Injuries, 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 2 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 7 Apr 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?
Device performance and benefits as related to Foot and Ankle Mobility Measure (time frame: 6 months post-operative). The study lists 3 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 7 Apr 2022.