DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

• Sponsor: DePuy Orthopaedics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00546429
• Collaborator: (none)
• Enrollment: 62
• Locations: 4
• Arm: 1
• Duration (Months): 36
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Femoral Fracture (Proximal)	Device: Intramedullary nailing	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 62 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: A Monitoring of trochanteric fractures after treatment with the ATN system.	Device: Intramedullary nailing; Trochanteric nailing for proximal femoral fractures.; Other Names: Ace Trochanteric Nail (ATN) system

Outcome Measures

Primary Outcome Measures

1. Success in Terms of the Merle D'Aubigne Score [4 weeks, 3, 6 and 12 months]

   Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.

Secondary Outcome Measures

1. Lower Extremity Measure (LEM) [4 weeks, 3, 6 and 12 months]

2. Medical Imaging [4 weeks, 3, 6 and 12 months]

3. Six Item Screener and Ambulatory Status [4 weeks, 3, 6 and 12 months]

4. SF-12 [4 weeks, 3, 6 and 12 months]

5. Merle d'Aubigne and Postel [4 weeks, 3, 6 and 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Front Range Orthopaedics	Colorado Springs	Colorado	United States	80910
2	Orthopaedic Physicians of Colorado	Englewood	Colorado	United States	80110
3	Erie County Medical Center	Buffalo	New York	United States	14215
4	Blue Ridge Bone and Joint	Asheville	North Carolina	United States	28801

Sponsors and Collaborators

• DePuy Orthopaedics

Investigators

• Study Director: Sam Himden, DePuy Orthopaedics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: DePuy Orthopaedics
• ClinicalTrials.gov Identifier: NCT00546429
• Other Study ID Numbers: 04077
• First Posted: Oct 19, 2007
• Last Update Posted: Feb 29, 2012
• Last Verified: Feb 1, 2012

• Keywords provided by DePuy Orthopaedics: Proximal femoral fracture; Trochanteric fracture; Intramedullary nailing
• Additional relevant MeSH terms: Fractures, Bone; Femoral Fractures

Study Results

Participant Flow

Recruitment Details	Between September 2006 & September 2009, 62 subjects were recruited and enrolled at 6 US clinics by orthopaedic surgeons. Each study site could enroll up to 20 subjects (cohorts were re-assigned as necessary to complete enrollment in a timely manner). Recruitment was based on the inclusion and exclusion criteria in the clinical investigation plan.
Pre-assignment Detail	This was a non-randomized study so all subjects that met the inclusion/exclusion criteria received the ATN Trochanteric Nail. Consented subjects could be excluded from the trial based on results of pre-operative clinical and/or radiographic evaluations, as per the exclusion criteria in the clinical investigation plan.

Arm/Group Title	DePuy Orthopaedics ATN Trochanteric Nail System
Arm/Group Description	The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
Period Title: Overall Study
STARTED	62
COMPLETED	32
NOT COMPLETED	30

Baseline Characteristics

Arm/Group Title	DePuy Orthopaedics ATN Trochanteric Nail System
Arm/Group Description	The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
Overall Participants	62
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	79.2 (14.1)
Sex: Female, Male (Count of Participants)
Female	42 67.7%
Male	20 32.3%
Region of Enrollment (participants) [Number]
United States	62 100%

Outcome Measures

1. Primary Outcome

Title	Success in Terms of the Merle D'Aubigne Score
Description	Merle D'Aubigne measures pain, mobility and ability to walk using a 0 to 6 scoring scale, with 0 indicating worse outcomes and 6 indicating better outcomes.
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	DePuy Orthopaedics ATN Trochanteric Nail System
Arm/Group Description	The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
Measure Participants	60
4 Week Merle D'Aubigne	5.2 (2.1)
3 Month Merle D'Aubigne	6.8 (2.4)
6 Month Merle D'Aubigne	7.3 (2.8)
12 Month Merle D'Aubigne	7.2 (3.0)

2. Secondary Outcome

Title	Lower Extremity Measure (LEM)
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	Medical Imaging
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	Six Item Screener and Ambulatory Status
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	SF-12
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	Merle d'Aubigne and Postel
Time Frame	4 weeks, 3, 6 and 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Arm/Group Title	DePuy Orthopaedics ATN Trochanteric Nail System
Arm/Group Description	The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
All Cause Mortality
	DePuy Orthopaedics ATN Trochanteric Nail System
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	DePuy Orthopaedics ATN Trochanteric Nail System
	Affected / at Risk (%)	# Events
Total	3/62 (4.8%)
General disorders
Death	1/62 (1.6%)	1
Injury, poisoning and procedural complications
Implant removal	1/62 (1.6%)	1
Musculoskeletal and connective tissue disorders
Bone fracture acetabulum	1/62 (1.6%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer	1/62 (1.6%)	1
Other (Not Including Serious) Adverse Events
	DePuy Orthopaedics ATN Trochanteric Nail System
	Affected / at Risk (%)	# Events
Total	4/62 (6.5%)
Respiratory, thoracic and mediastinal disorders
Respiratory system	4/62 (6.5%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.