Grappler® Interference Screw Post-Market Clinical Follow-Up Study
1 other identifier
observational
50
1 country
1
Brief Summary
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 19, 2021
CompletedFirst Submitted
Initial submission to the registry
May 11, 2021
CompletedFirst Posted
Study publicly available on registry
May 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 11, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 25, 2022
CompletedNovember 15, 2023
March 1, 2022
11 months
May 11, 2021
November 14, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
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
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
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 Outcomes (7)
Rate of recurrence of deformity
7 Weeks Post-Op, 6 Months Post-Op
Rate of implant failure
Intra-Op, 7 Weeks Post-Op, 6 Months Post-Op
Rate of re-tear or re-rupture of fixated soft tissue
7 Weeks Post-Op, 6 Months Post-Op
Rate of screw removal
7 Weeks Post-Op, 6 Months Post-Op
Foot and Ankle Mobility Measure
6 months post-operative
- +2 more secondary outcomes
Interventions
Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
Eligibility Criteria
The investigational population will include a minimum of 50 subjects who have undergone a foot and/or ankle procedure that fulfill the eligibility criteria
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Paragon 28lead
Study Sites (1)
Orthopedic Foot and Ankle
Worthington, Ohio, 43085, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jacy Legue
Paragon 28
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 11, 2021
First Posted
May 20, 2021
Study Start
April 19, 2021
Primary Completion
March 11, 2022
Study Completion
March 25, 2022
Last Updated
November 15, 2023
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share