NCT00546429: ATN

DePuy Trochanteric (ATN) Nailing Clinical Outcomes Trial

Completed Results posted Last updated 6 June 2023

What this trial tests

trial testing Intramedullary nailing in Femoral Fracture (Proximal) in 62 participants. Completed in 1 September 2009.

Timeline

1 September 2006

Primary endpoint
1 September 2009

1 September 2009

Quick facts

Lead sponsor	DePuy Orthopaedics
Status	Completed
Study type	OBSERVATIONAL
Enrollment	62
Start date	1 September 2006
Primary completion	1 September 2009
Estimated completion	1 September 2009
Sites	4 locations across United States

Drugs / interventions tested

• Intramedullary nailing

Conditions studied

• Femoral Fracture (Proximal) — all drugs for Femoral Fracture (Proximal) →

Sponsor

DePuy Orthopaedics — full company profile →

Who can join

18 and older, any sex, with Femoral Fracture (Proximal). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Success in Terms of the Merle D'Aubigne Postel Score for Pain Category Primary · 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 Week Merle D'Aubigne for Pain Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	4.1	± 1.2

3 Month Merle D'Aubigne Pain Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	4.4	± 1.4

6 Month Merle D'Aubigne Pain Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	4.5	± 1.3

12 Month Merle D'Aubigne Pain Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	4.6	± 1.6

Success in Terms of the Merle D'Aubigne Postel Score for Walk Category Primary · 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 Week Merle D'Aubigne for Walk Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	1.3	± 1.3

3 Month Merle D'Aubigne Walk Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	2.6	± 1.7

6 Month Merle D'Aubigne Walk Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	3.0	± 1.9

12 Month Merle D'Aubigne Walk Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	2.7	± 1.9

Success in Terms of the Merle D'Aubigne Postel Score for Mobility Category Primary · 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 Week Merle D'Aubigne for Mobility Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	5.2	± 1.3

3 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	5.4	± 1.0

6 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	5.4	± 1.0

12 Month Merle D'Aubigne Mobility Score (0 worst to 6 best)

Group	Value	95% CI
DePuy Orthopaedics ATN Trochanteric Nail System	5.6	± 0.8

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

DePuy Orthopaedics ATN Trochanteric Nail System

Serious: 3/62 (5%)

Deaths: —

Serious adverse events (4 terms)

Reaction	System	DePuy Orthopaedics ATN Tro…
Bone fracture acetabulum	Musculoskeletal and connective tissue disorders	—
Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—
Death	General disorders	—
Implant removal	Injury, poisoning and procedural complications	—

Other adverse events (1 terms — click to expand)

Reaction	System	DePuy Orthopaedics ATN Tro…
Respiratory system	Respiratory, thoracic and mediastinal disorders	—

Most-reported serious reactions: Bone fracture acetabulum, Cancer, Death, Implant removal.

Data from ClinicalTrials.gov NCT00546429 adverse events section.

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.