Intertrochanteric FracturesNCT05559736
Artemis Proximal Femoral Nail for Internal Fixation of Intertrochanteric Femur Fractures
A study testing Artemis Proximal Femoral Nail (PFN) implant in people with Intertrochanteric Fractures and Femoral Fracture, run by Johns Hopkins University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intertrochanteric Fractures, Femoral Fracture, Femoral Neck Fractures
- What is being tested?
- Artemis Proximal Femoral Nail (PFN) implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2023to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation
Who cannot join
- Pediatric patients (<18 years)
- Pregnant females
- Patients with other concomitant orthopaedic injuries
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21244
About this study
Official title: Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
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.
Read the detailed 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.
- Being tested
- Artemis Proximal Femoral Nail (PFN) implant
- Keywords
- Femoral nail, Cephalomedullary nail, Artemis Proximal Femoral Nail, Intertrochanteric femur fractures
- Medical subject headings
- Hip Fractures, Femoral Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artemis Proximal Femoral Nail (PFN) implantDevice
Artemis Proximal Femoral Nail (PFN) implant
| Study group | Role | What they receive |
|---|---|---|
| Artemis Proximal Femoral Nail (PFN) implant | Experimental | All participants will receive the Artemis Proximal Femoral Nail (PFN) implant. Receives: Device: Artemis Proximal Femoral Nail (PFN) implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of fracture nonunion
Measured: Up to 6 months
Rate of implant-related failure
Measured: Up to 6 months
Secondary outcomes (14)
Preoperative pain as assessed by a visual analog scale
Visual Analog Scale: 1(least pain) - 10(most pain).
Measured: 30 days preoperatively
Preoperative function as assessed by the Functional Independence Measure
Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).
Measured: 30 days preoperatively
Operative duration
Operative duration in minutes.
Measured: Intraoperative
Fluoroscopy usage time
Fluoroscopy usage time in minutes.
Measured: Intraoperative
Estimated blood loss
Estimated blood loss in milliliters (mL).
Measured: Intraoperative
Duration of hospital stay
Duration of hospital stay in days.
Measured: Perioperative, up to 6 months post procedure
Discharge disposition
Discharge to home vs. rehab facility
Measured: Perioperative, up to 6 months post procedure
Postoperative complications
Any postoperative complications, including: infection, hematoma, thrombosis/embolism, delayed wound healing, etc.
Measured: Up to 6 months
Postoperative pain as assessed by a visual analog scale
Visual Analog Scale: 1(least pain) - 10(most pain).
Measured: Up to 6 months
Postoperative function as assessed by the Functional Independence Measure
Functional Independence Measure: 1(total functional dependence) - 7(total functional independence).
Measured: Up to 6 months
Use of gait-aid device
Use of gait-aid device (wheelchair, walker, cane).
Measured: Up to 6 months
Postoperative radiographic healing
Fracture healing, position of implant, implant-related failure (subsidence, cutout, loosening, implant fracture).
Measured: Up to 6 months
Financial costs
Implant purchase/manufacturing costs.
Measured: Intraoperative
Environmental costs
Carbon waste footprint.
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start24 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Why it stopped: no interest in using implant
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intertrochanteric FracturesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Innov8ortho
- Responsible party
- Sponsor
- Investigators
- Amiethab Aiyer, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05559736
- Sponsor's protocol ID
- IRB00344949
- Status last verified
- Dec 2025
- First submitted
- 26 Sep 2022
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation: Artemis Proximal Femoral Nail (PFN) for Internal Fixation of Intertrochanteric Femur Fractures
- ClinicalTrials.gov ID
- NCT05559736
- Acronym / sponsor ID
- IRB00344949
- Keywords
- Femoral nail, Cephalomedullary nail, Artemis Proximal Femoral Nail, Intertrochanteric femur fractures
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no interest in using implant
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Innov8ortho
- Study start
- 24 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 29 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Artemis Proximal Femoral Nail (PFN) implant | Experimental | Device: Artemis Proximal Femoral Nail (PFN) implantAll participants will receive the Artemis Proximal Femoral Nail (PFN) implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients with traumatic, non-pathologic stable intertrochanteric fractures requiring cephalomedullary nail fixation
Key exclusion criteria (3 listed)
- Pediatric patients (<18 years)
- Pregnant females
- Patients with other concomitant orthopaedic injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artemis Proximal Femoral Nail (PFN) implantArtemis Proximal Femoral Nail (PFN) implant | Device | Artemis Proximal Femoral Nail (PFN) implant |
Primary outcome
Rate of fracture nonunion
Time frame: Up to 6 months
Rate of implant-related failure
Time frame: Up to 6 months
14 secondary outcomes
Preoperative pain as assessed by a visual analog scale
Time frame: 30 days preoperatively
Preoperative function as assessed by the Functional Independence Measure
Time frame: 30 days preoperatively
Operative duration
Time frame: Intraoperative
Fluoroscopy usage time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperative
Duration of hospital stay
Time frame: Perioperative, up to 6 months post procedure
Discharge disposition
Time frame: Perioperative, up to 6 months post procedure
Postoperative complications
Time frame: Up to 6 months
Postoperative pain as assessed by a visual analog scale
Time frame: Up to 6 months
Postoperative function as assessed by the Functional Independence Measure
Time frame: Up to 6 months
Use of gait-aid device
Time frame: Up to 6 months
Postoperative radiographic healing
Time frame: Up to 6 months
Financial costs
Time frame: Intraoperative
Environmental costs
Time frame: Intraoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amiethab Aiyer, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artemis Proximal Femoral Nail (PFN) implant in people with Intertrochanteric Fractures and Femoral Fracture, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of fracture nonunion (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.