Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures

Paragon 28

Status

Completed

Conditions

Achilles Tendon Rupture

Flexor Hallucis Longus on the Right

Flexor Digitorum Longus on the Right

Ankle Sprains

Syndesmotic Injuries

Flexor Hallucis Longus on the Left

Deltoid Ankle Sprain

Ankle Injuries

Flexor Digitorum Longus on the Left

Ankle Inversion Sprain

Treatments

Device: Grappler Interference Screw System

Study type

Observational

Funder types

Industry

Identifiers

NCT05190874

P41-SP-0002

Details and patient eligibility

About

Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.

Full 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.

Enrollment

19 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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)

Exclusion criteria