Trials / Completed
CompletedNCT05190874
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 19 (actual)
- Sponsor
- Paragon 28 · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
- Ankle Injuries
- Syndesmotic Injuries
- Ankle Inversion Sprain
- Deltoid Ankle Sprain
- Achilles Tendon Rupture
- Flexor Hallucis Longus on the Left
- Flexor Hallucis Longus on the Right
- Flexor Digitorum Longus on the Left
- Flexor Digitorum Longus on the Right
- Ankle Sprains
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Grappler Interference Screw System | Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System |
Timeline
- Start date
- 2022-01-14
- Primary completion
- 2022-03-11
- Completion
- 2022-04-06
- First posted
- 2022-01-13
- Last updated
- 2022-04-07
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05190874. Inclusion in this directory is not an endorsement.