CompletedNot Applicable

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

United States19 participantsStarted 2022-01-14

Plain-language summary

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

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * None

What they're measuring

Device performance and benefits as related to Foot and Ankle Mobility Measure

Timeframe: 6 months post-operative

Device performance and benefits as related to pain levels based on the Visual Analog Scale

Timeframe: 6 months post-operative

Device performance and benefits as related to pain levels based on Patient satisfaction

Timeframe: 6 months post-operative

Trial details

NCT IDNCT05190874

SponsorParagon 28

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2022-03-11

View on ClinicalTrials.gov More Ankle Injuries trials