Ankle InjuriesNCT04893824
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
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
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Apr 2021to 25 Mar 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
- Child, Adult, Older adult
Study population: The investigational population will include a minimum of 50 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Who may be able to join
- The subject must have undergone 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 must have adequate radiographic and medical records for the minimum follow-up requirement of six months
- 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
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 a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of revisions
Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation.
Measured: 6 Months Post-Op
Incidence of adverse events
Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation.
Measured: 6 Months Post-Op
Incidence of complications
Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation.
Measured: 6 Months Post-Op
Secondary outcomes (7)
Rate of recurrence of deformity
Safety as related to rate of recurrence of deformity
Measured: 7 Weeks Post-Op, 6 Months Post-Op
Rate of implant failure
Safety as related to rate of implant failure
Measured: Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
Rate of re-tear or re-rupture of fixated soft tissue
Safety as related to rate of re-tear or re-rupture of fixated soft tissue
Measured: 7 Weeks Post-Op, 6 Months Post-Op
Rate of screw removal
Safety as related to rate of screw removal
Measured: 7 Weeks Post-Op, 6 Months Post-Op
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
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: 6 months post-operative
Patient satisfaction
Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)
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 posted20 May 2021
- Study start19 Apr 2021
- Primary completion11 Mar 2022
- Study completion25 Mar 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
- 50 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
- NCT04893824
- Sponsor's protocol ID
- P41-SP-0001
- Status last verified
- Mar 2022
- First submitted
- 11 May 2021
- Last updated
- 15 Nov 2023
- 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 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Grappler® Interference Screw Post-Market Clinical Follow-Up Study
- ClinicalTrials.gov ID
- NCT04893824
- Acronym / sponsor ID
- P41-SP-0001
- 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
- 50 participants (actual)
- Lead sponsor
- Paragon 28Industry (pharma, biotech, devices)
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 11 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 20 May 2021 (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 a ambispective, multi-surgeon, single site, consecutive case series. Data collection will occur in two phases. Retrospective data collection will occur upon subject identification, and data will be collected from the site's medical records for minimum of 50 subjects who have undergone soft tissue to bone fixation with the Grappler® Interference Screw System. Data will be collected from the subjects' pre-op visits, intra-op visits, 7 week post-op follow-up visits (± 4 weeks), and 6 month post-op follow-up visits (± 4 weeks). The subject must have adequate radiographic and medical records for the minimum follow up requirement of 6 months. Prospective data collection will occur upon subject's provision of written informed consent, and data will be collected from patient reported outcomes (PRO's).
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- The investigational population will include a minimum of 50 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
Key inclusion criteria (4 listed)
- The subject must have undergone 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 must have adequate radiographic and medical records for the minimum follow-up requirement of six months
- 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 |
|---|---|---|
| Grappler® Interference Screw SystemFoot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System | Device | – |
Primary outcome
Incidence of revisions
Time frame: 6 Months Post-Op
Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation.
Incidence of adverse events
Time frame: 6 Months Post-Op
Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation.
Incidence of complications
Time frame: 6 Months Post-Op
Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation.
7 secondary outcomes
Rate of recurrence of deformity
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
Rate of implant failure
Time frame: Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
Rate of re-tear or re-rupture of fixated soft tissue
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
Rate of screw removal
Time frame: 7 Weeks Post-Op, 6 Months Post-Op
Foot and Ankle Mobility Measure
Time frame: 6 months post-operative
Visual Analog Scale
Time frame: 6 months post-operative
Patient satisfaction
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 15 Nov 2023.
- 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 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 15 Nov 2023. 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 revisions (time frame: 6 Months Post-Op). 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 15 Nov 2023.