Femoral Fracture (Proximal)ATNNCT00546429

DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

An observational study of Femoral Fracture (Proximal), run by DePuy Orthopaedics at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Femoral Fracture (Proximal)
What is being tested?: Intramedullary nailing
Type of treatment: Medical device
How many people: 62 participants
Where: 4 sitesUnited States
Study dates: 1 Sep 2006to 1 Sep 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Ability to understand and willing to sign the approved consent form.
18 years of age
Skeletally mature
Have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the AO Proximal Femur Fracture Classification

Who cannot join

Subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation.
Subjects who have isolated or combined medial femoral neck fractures.
Subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery.
Subjects who are pregnant or breastfeeding.
Subjects who are a prisoner or a known alcohol or drug abuser.
Subjects who have a prior surgical history in the affected hip, or conditions that may interfere with outcome or impede healing.

Show all 13Show fewer

Subjects who have an obliterated medullary canal or other conditions that may complicate the reaming process.
Subjects who have evidence of active untreated infections that may spread to other areas of the body.
Subjects who have a highly communicable disease or pathology that may limit follow-up.
Subjects, who in the opinion of the Clinical Investigator, have an existing condition that indicates the Subject is not a good candidate for the study.
Subjects who are participating in another clinical investigation.
Subjects known to have allergies to titanium, aluminum, vanadium.
Subjects who are currently eligible for workman's compensation.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Blue Ridge Bone and Joint
Asheville, North Carolina, 28801
Erie County Medical Center
Buffalo, New York, 14215
Front Range Orthopaedics
Colorado Springs, Colorado, 80910
Orthopaedic Physicians of Colorado
Englewood, Colorado, 80110

Other trials in United States

About this study

Official title: Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur

The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.

Read the detailed description

Proximal femoral fractures are among the most common femoral fractures. In the past plates and screws were often used to repair these fractures but this treatment had limitations including restricted weight bearing. Intermedullary nailing is an alternative to plate and screw treatment. Weight bearing is allowed and the procedure can be a less invasive. Among intramedullary nailing complications are iatrogenic fractures that can be further divided into trochanteric and femoral shaft fractures. Trochanteric fractures often heal without additional intervention however femoral shaft fractures usually require an additional surgical procedure to facilitate healing. This study will monitor fracture healing using clinical and radiographic evaluations of subjects with trochanteric fractures of the proximal femur treated with the ATN system.

Conditions: Femoral Fracture (Proximal)
Being tested: Intramedullary nailing
Keywords: Proximal femoral fracture, Trochanteric fracture, Intramedullary nailing
Medical subject headings: Proximal Femoral Fractures, Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intramedullary nailingDevice
Also called Ace Trochanteric Nail (ATN) system
Trochanteric nailing for proximal femoral fractures.

Study groups in NCT00546429
Study group	Role	What they receive
A		Monitoring of trochanteric fractures after treatment with the ATN system. Receives: Device: Intramedullary nailing

What is being measured

The primary outcome is the main question the study is designed to answer.

Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Measured: 4 weeks, 3, 6 and 12 months
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Measured: 4 weeks, 3, 6 and 12 months
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Measured: 4 weeks, 3, 6 and 12 months

Secondary outcomes (4)

Lower Extremity Measure (LEM)
Measured: 4 weeks, 3, 6 and 12 months
Medical Imaging
Measured: 4 weeks, 3, 6 and 12 months
Six Item Screener and Ambulatory Status
Measured: 4 weeks, 3, 6 and 12 months
SF-12
Measured: 4 weeks, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20061 Sep 2009

First posted19 Oct 2007 (estimated)
Study start1 Sep 2006
Primary completion1 Sep 2009
Study completion1 Sep 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Femoral Fracture (Proximal)Studies of the same condition, open and under way.
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: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 62 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00546429
Sponsor's protocol ID: 04077
Acronym: ATN
Status last verified: Jun 2023
First submitted: 17 Oct 2007
Last updated: 6 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Proximal Femoral Metastases
RecruitingObservational study
Frailty and Nottingham Hip Fracture Score for Predicting 90-Day Mortality After Hip Fracture Surgery
Hip Fracture, Proximal Femur Fracture
Recruiting
Is Two-on-one Instruction in Virtual Reality Simulation-based Training of Operating Fractures of the Hip for Medical Students as Effective as One-on-one Instruction
Learning Curves and Outcomes of Simulation-based Training
Not yet recruiting
Ultrasound-Guided PENG Block vs Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Hip Fracture Surgery
Proximal Femur Fracture, Hip Fracture
Recruiting
Opioid-Free Pain Treatment in Trauma Patients
Femoral Neck Fractures, Intertrochanteric Fractures

All Femoral Fracture (Proximal) trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Trial to Monitor the Clinical Effectiveness of the DePuy ATN Trochanteric Nailing System in the Treatment of Trochanteric Fractures of the Proximal Femur
ClinicalTrials.gov ID: NCT00546429
Acronym / sponsor ID: ATN / 04077
Conditions: Femoral Fracture (Proximal)
Keywords: Proximal femoral fracture, Trochanteric fracture, Intramedullary nailing
Study type: Observational
Recruitment status: Completed
Enrolment: 62 participants (actual)
Lead sponsor: DePuy OrthopaedicsIndustry (pharma, biotech, devices)
Study start: 1 Sep 2006 (actual)
Primary completion: 1 Sep 2009 (actual)
Study completion: 1 Sep 2009 (actual)
First posted: 19 Oct 2007 (estimated)
Results: Posted 10 Dec 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to monitor trochanteric fracture healing and review the performance of the ATN system.

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
A	–	Device: Intramedullary nailingMonitoring of trochanteric fractures after treatment with the ATN system.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Ability to understand and willing to sign the approved consent form.
18 years of age
Skeletally mature
Have stable or unstable proximal femur fracture, including pertrochanteric, intertrochanteric, high subtrochanteric or any combination of the AO Proximal Femur Fracture Classification

Key exclusion criteria (13 listed)

Subjects with concomitant lower extremity injuries or multiple trauma that would interfere with normal hip fracture rehabilitation.
Subjects who have isolated or combined medial femoral neck fractures.
Subjects who are unwilling or unable to comply with a rehabilitation program or are unwilling or unable to be assessed for 1 year following surgery.
Subjects who are pregnant or breastfeeding.
Subjects who are a prisoner or a known alcohol or drug abuser.

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
Intramedullary nailingAlso: Ace Trochanteric Nail (ATN) systemTrochanteric nailing for proximal femoral fractures.	Device	A

Primary outcome

Success in Terms of the Merle D'Aubigne Postel Score for Pain Category
Time frame: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Success in Terms of the Merle D'Aubigne Postel Score for Walk Category
Time frame: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately
Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category
Time frame: 4 weeks, 3, 6 and 12 months
Merle D'Aubigne measures three categories for Pain, Mobility and Ability to walk using a 0 to 6 scoring scale for each category. Scoring is 0 indicating worse outcomes and 6 indicating better outcomes. Each Category is scored and reported separately

4 secondary outcomes

Lower Extremity Measure (LEM)
Time frame: 4 weeks, 3, 6 and 12 months
Medical Imaging
Time frame: 4 weeks, 3, 6 and 12 months
Six Item Screener and Ambulatory Status
Time frame: 4 weeks, 3, 6 and 12 months
SF-12
Time frame: 4 weeks, 3, 6 and 12 months

Results and safety

Results posted to the registry on 10 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DePuy Orthopaedics ATN Trochanteric Nail System	62	32

Primary outcome: Success in Terms of the Merle D'Aubigne Postel Score for Pain Category

Time frame: 4 weeks, 3, 6 and 12 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	DePuy Orthopaedics ATN Trochanteric Nail System n = 60
4 Week Merle D'Aubigne for Pain Score (0 worst to 6 best)	4.1 (1.2)
3 Month Merle D'Aubigne Pain Score (0 worst to 6 best)	4.4 (1.4)
6 Month Merle D'Aubigne Pain Score (0 worst to 6 best)	4.5 (1.3)
12 Month Merle D'Aubigne Pain Score (0 worst to 6 best)	4.6 (1.6)

Primary outcome: Success in Terms of the Merle D'Aubigne Postel Score for Walk Category

Time frame: 4 weeks, 3, 6 and 12 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	DePuy Orthopaedics ATN Trochanteric Nail System n = 60
4 Week Merle D'Aubigne for Walk Score (0 worst to 6 best)	1.3 (1.3)
3 Month Merle D'Aubigne Walk Score (0 worst to 6 best)	2.6 (1.7)
6 Month Merle D'Aubigne Walk Score (0 worst to 6 best)	3.0 (1.9)
12 Month Merle D'Aubigne Walk Score (0 worst to 6 best)	2.7 (1.9)

Primary outcome: Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category

Time frame: 4 weeks, 3, 6 and 12 months. Mean (Standard Deviation). Unit: Units on a scale

Measure	DePuy Orthopaedics ATN Trochanteric Nail System n = 60
4 Week Merle D'Aubigne for Mobility Score (0 worst to 6 best)	5.2 (1.3)
3 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)	5.4 (1.0)
6 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)	5.4 (1.0)
12 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)	5.6 (0.8)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DePuy Orthopaedics ATN Trochanteric Nail System	3 of 62 (4.8%)	4 of 62 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Femoral Fracture (Proximal)

Active, not recruiting
A Randomized Trial to Assess Patient Quality of Life and Function After Alternative Surgeries for Pathologic Fractures of the Femur
Proximal Femoral Metastases
RecruitingObservational study
Frailty and Nottingham Hip Fracture Score for Predicting 90-Day Mortality After Hip Fracture Surgery
Hip Fracture, Proximal Femur Fracture
Recruiting
Is Two-on-one Instruction in Virtual Reality Simulation-based Training of Operating Fractures of the Hip for Medical Students as Effective as One-on-one Instruction
Learning Curves and Outcomes of Simulation-based Training
Not yet recruiting
Ultrasound-Guided PENG Block vs Femoral Nerve Block for Analgesia Before Spinal Anesthesia in Hip Fracture Surgery
Proximal Femur Fracture, Hip Fracture
Recruiting
Opioid-Free Pain Treatment in Trauma Patients
Femoral Neck Fractures, Intertrochanteric Fractures

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.

Sam Himden study director

DePuy Orthopaedics

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Femoral Fracture (Proximal), run by DePuy Orthopaedics at 4 sites 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 4 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites 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?

Yes. Results are posted in the registry (first posted 10 Dec 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Success in Terms of the Merle D'Aubigne Postel Score for Pain Category (time frame: 4 weeks, 3, 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00546429.

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 6 Jun 2023; AzTrials last refreshed its copy on 7 Nov 2026.