Clinical trial NCT04893824: Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Official title: Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Injuries
Syndesmotic Injuries
Ankle Inversion Sprain
Deltoid Ankle Sprain
Achilles Tendon Rupture
Flexor Hallucis Longus on the Left
Flexor Digitorum Longus on the Left
Ankle Sprains
Flexor Hallucis Longus on the Right
Flexor Digitorum Longus on the Right
Lead sponsor: Paragon 28
Sponsor class: INDUSTRY
First posted: 2021-05-20
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

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).

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of revisions
timeFrame: 6 Months Post-Op
measure: Incidence of adverse events
timeFrame: 6 Months Post-Op
measure: Incidence of complications
timeFrame: 6 Months Post-Op
Secondary outcomes:
measure: Rate of recurrence of deformity
timeFrame: 7 Weeks Post-Op, 6 Months Post-Op
measure: Rate of implant failure
timeFrame: Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
measure: Rate of re-tear or re-rupture of fixated soft tissue
timeFrame: 7 Weeks Post-Op, 6 Months Post-Op
measure: Rate of screw removal
timeFrame: 7 Weeks Post-Op, 6 Months Post-Op
measure: Foot and Ankle Mobility Measure
timeFrame: 6 months post-operative
measure: Visual Analog Scale
timeFrame: 6 months post-operative
measure: Patient satisfaction
timeFrame: 6 months post-operative
Other outcomes:
Locations:
city: Worthington
country: United States
facility: Orthopedic Foot and Ankle
state: Ohio
Study officials:
affiliation: Paragon 28
name: Jacy Legue
role: STUDY_DIRECTOR
References: