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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05559736
Other study ID # IRB00344949
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 24, 2023
Est. completion date August 30, 2024

Study information

Verified date April 2024
Source Johns Hopkins University
Contact Amiethab Aiyer, MD
Phone 2155101722
Email aaiyer2@jhmi.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Intertrochanteric femur fractures are a common injury pattern seen after acute hip trauma, with a very high rate of morbidity and mortality particularly among elderly patients. Cephalomedullary nail fixation has become a mainstay of treatment for both stable and unstable intertrochanteric fractures, offering greater stability than other options without replacing the native hip joint when possible. Despite this, the incidence of fracture nonunion remains high, resulting in poor functional outcomes, higher healthcare costs, and conversion to hemi- or total hip arthroplasty. 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 Artemis PFN implant offers several purported advantages over existing implants. It is manufactured with a titanium core coated with carbon-fiber reinforced polyetheretherketone (PEEK), combining the strength of titanium with the bone-imitating biomechanical properties and radiolucency of PEEK. A number of additional features built into the Artemis System are designed to facilitate lower-complexity assembly/insertion, as well as reduce the likelihood of implant failure. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 30, 2024
Est. primary completion date July 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Device:
Artemis Proximal Femoral Nail (PFN) implant
Artemis Proximal Femoral Nail (PFN) implant

Locations

Country Name City State
United States Johns Hopkins Bayview Medical Center Baltimore Maryland

Sponsors (1)

Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of fracture nonunion Up to 6 months
Primary Rate of implant-related failure Up to 6 months
Secondary Preoperative pain as assessed by a visual analog scale Visual Analog Scale: 1(least pain) - 10(most pain). 30 days preoperatively
Secondary Preoperative function as assessed by the Functional Independence Measure Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). 30 days preoperatively
Secondary Operative duration Operative duration in minutes. Intraoperative
Secondary Fluoroscopy usage time Fluoroscopy usage time in minutes. Intraoperative
Secondary Estimated blood loss Estimated blood loss in milliliters (mL). Intraoperative
Secondary Duration of hospital stay Duration of hospital stay in days. Perioperative, up to 6 months post procedure
Secondary Discharge disposition Discharge to home vs. rehab facility Perioperative, up to 6 months post procedure
Secondary Postoperative complications Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc. Up to 6 months
Secondary Postoperative pain as assessed by a visual analog scale Visual Analog Scale: 1(least pain) - 10(most pain). Up to 6 months
Secondary Postoperative function as assessed by the Functional Independence Measure Functional Independence Measure: 1(total functional dependence) - 7(total functional independence). Up to 6 months
Secondary Use of gait-aid device Use of gait-aid device (wheelchair, walker, cane). Up to 6 months
Secondary Postoperative radiographic healing Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture). Up to 6 months
Secondary Financial costs Implant purchase/manufacturing costs. Intraoperative
Secondary Environmental costs Carbon waste footprint. Intraoperative
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