Grappler® Interference Screw Post-Market Clinical Follow-Up Study

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

NCT04893824

P41-SP-0001

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 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).

Enrollment: 50 patients

Sex: All

Volunteers: No Healthy Volunteers

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