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

Ankle Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04893824
• Other study ID #: P41-SP-0001
• Status: Completed
• Start date: April 19, 2021
• Est. completion date: March 25, 2022

Study information

• Verified date: March 2022
• Source: Paragon 28
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: March 25, 2022
• Est. primary completion date: March 11, 2022
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Achilles Tendon Rupture
• Ankle Injuries
• Ankle Inversion Sprain
• Ankle Sprains
• Flexor Digitorum Longus on the Left
• Flexor Digitorum Longus on the Right
• Rupture
• Sprains and Strains
• Syndesmotic Injuries
• Wounds and Injuries

Intervention

Device:
• Grappler® Interference Screw System
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System

Locations

Country	Name	City	State
United States	Orthopedic Foot and Ankle	Worthington	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Paragon 28

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of revisions	Safety will be assessed by recording the incidence of revisions. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op
Primary	Incidence of adverse events	Safety will be assessed by recording the incidence of adverse events. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op
Primary	Incidence of complications	Safety will be assessed by recording the incidence of complications. The relationship of events will be attributed to either the implant or instrumentation.	6 Months Post-Op
Secondary	Rate of recurrence of deformity	Safety as related to rate of recurrence of deformity	7 Weeks Post-Op, 6 Months Post-Op
Secondary	Rate of implant failure	Safety as related to rate of implant failure	Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
Secondary	Rate of re-tear or re-rupture of fixated soft tissue	Safety as related to rate of re-tear or re-rupture of fixated soft tissue	7 Weeks Post-Op, 6 Months Post-Op
Secondary	Rate of screw removal	Safety as related to rate of screw removal	7 Weeks Post-Op, 6 Months Post-Op
Secondary	Foot and Ankle Mobility Measure	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.	6 months post-operative
Secondary	Visual Analog Scale	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)	6 months post-operative
Secondary	Patient satisfaction	Device performance and benefits as related to patient satisfaction (very satisfied, good, fair, not satisfied)	6 months post-operative