WithdrawnNot Applicable

Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures

Stopped: no interest in using implant

United States0Started 2023-05-24

Plain-language summary

In February 2021, Altior Trauma Innovations™ announced that it had received 501(k) FDA approval for the Artemis Proximal Femoral Nail (PFN) System for internal fixation of intertrochanteric femur fractures. The objective of this pilot study is to evaluate safety, efficacy and feasibility of the Artemis PFN implant for operative fixation of intertrochanteric femoral fractures, compared to matched historical control patients who received other implants.

Who can participate

Age range18 Years

SexALL

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

Inclusion Criteria: * All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation Exclusion Criteria: * Pediatric patients (\<18 years) * Pregnant females * Patients with other concomitant orthopaedic injuries

What they're measuring

Rate of fracture nonunion

Timeframe: Up to 6 months

Rate of implant-related failure

Timeframe: Up to 6 months

Trial details

NCT IDNCT05559736

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Intertrochanteric Fractures trials