Achilles Tendon Rupture, Ankle Injuries, Ankle Inversion Sprain, Ankle Sprains, Deltoid Ankle Sprain, Flexor Digitorum Longus on the Left, Flexor Digitorum Longus on the Right, Flexor Hallucis Longus on the Left, Flexor Hallucis Longus on the Right, Syndesmotic Injuries
Conditions
Brief 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 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).
Interventions
DEVICEGrappler® Interference Screw System
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
Sponsors
Paragon 28
Study design
Observational model
CASE_ONLY
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Inclusion criteria
* 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
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of revisions | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of screw removal | 7 Weeks Post-Op, 6 Months Post-Op | Safety as related to rate of screw removal |
| Foot and Ankle Mobility Measure | 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. |
| Rate of recurrence of deformity | 7 Weeks Post-Op, 6 Months Post-Op | Safety as related to rate of recurrence of deformity |
| Patient satisfaction | 6 months post-operative | Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied) |
| Visual Analog Scale | 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) |
| Rate of implant failure | Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op | Safety as related to rate of implant failure |
| Rate of re-tear or re-rupture of fixated soft tissue | 7 Weeks Post-Op, 6 Months Post-Op | Safety as related to rate of re-tear or re-rupture of fixated soft tissue |
Countries
United States
Outcome results
None listed