Trial Outcomes & Findings for A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures (NCT NCT00429663)

NCT ID: NCT00429663

Last Updated: 2017-05-11

Results Overview

EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 160 participants
• Primary outcome timeframe: 3 months, 6 months, 12 months
• Results posted on: 2017-05-11

Participant Flow

Although 160 participants were enrolled into the study, only 156 were included in the participant flow because 2 were found ineligible after consent and 2 withdrew before fixation.

Participant milestones

Measure	IM Nails Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Overall Study STARTED	76	80
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	36	39

Reasons for withdrawal

Measure	IM Nails Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Overall Study Lost to Follow-up	24	31
Overall Study Physician Decision	6	3
Overall Study Withdrawal by Subject	2	5
Overall Study Death	4	0

Baseline Characteristics

A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Distal Femur Fractures

Baseline characteristics by cohort

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures	Total n=126 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	48 Participants n=7 Participants	89 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	20 Participants n=7 Participants	36 Participants n=5 Participants
Age, Continuous	51 years n=5 Participants	53 years n=7 Participants	51 years n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants	33 Participants n=7 Participants	55 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	35 Participants n=7 Participants	71 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months, 6 months, 12 months

Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.

EQ-5D (EuroQol) Health Index taken at 3 months, 6 months, 12 months follow up. The EQ-5D measures the subjects health status in 5 categories (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and totals them into 1 score. Scoring ranges from 0-100, 100 being best.

Outcome measures

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
EQ-5D 3 months	69.23 units on a scale Standard Deviation 17.64	72.81 units on a scale Standard Deviation 18.85
EQ-5D 6 months	74.24 units on a scale Standard Deviation 13.65	73.04 units on a scale Standard Deviation 24.11
EQ-5D 12 months	79.07 units on a scale Standard Deviation 16.01	71.9 units on a scale Standard Deviation 23.34

PRIMARY outcome

Timeframe: 3 months, 6 months, 12 months

Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects entered were followed.

The Short Musculoskeletal Functional Assessment (SMFA) score. The questionnaire consists of four categories: Daily Activities, Emotional Status, Arm and Hand Function, Mobility. All categories are scored together, totaling between 0-100. The lower the score, the better the subjects function.

Outcome measures

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Short Musculoskeletal Functional Assessment (SMFA) Score 3 months	38.76 units on a scale Standard Deviation 19.21	41.58 units on a scale Standard Deviation 19.17
Short Musculoskeletal Functional Assessment (SMFA) Score 6 months	29.82 units on a scale Standard Deviation 18.79	31.92 units on a scale Standard Deviation 22.22
Short Musculoskeletal Functional Assessment (SMFA) Score 12 months	22.18 units on a scale Standard Deviation 15.54	26.83 units on a scale Standard Deviation 23.18

PRIMARY outcome

Timeframe: 3 months, 6 months, 12 months

Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.

EQ Index is a visual analog scale that the subject uses to rank overall health and wellness on a scale of 0.00-1.00, 1.00 being best.

Outcome measures

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
EQ Index 3 months	0.63 units on a scale Standard Deviation .23	0.59 units on a scale Standard Deviation .19
EQ Index 6 months	0.73 units on a scale Standard Deviation .27	0.68 units on a scale Standard Deviation .20
EQ Index 12 months	0.76 units on a scale Standard Deviation .23	0.70 units on a scale Standard Deviation .17

PRIMARY outcome

Timeframe: 3 months, 6 months, 12 months

Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.

The Bother Index is part of the SMFA. This section focuses on how much the injury is bothering the subject in terms of daily activities and use of injured area. The index totals are between 0-100. The lower the score, the less bothered the subject is by their injury.

Outcome measures

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
SMFA - Bother Index 3 months	40.46 units on a scale Standard Deviation 21.95	36.75 units on a scale Standard Deviation 18.85
SMFA - Bother Index 6 months	28.23 units on a scale Standard Deviation 18.34	29.94 units on a scale Standard Deviation 24.34
SMFA - Bother Index 12 months	22.97 units on a scale Standard Deviation 19.12	28.93 units on a scale Standard Deviation 28.68

SECONDARY outcome

Timeframe: 12 months

Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.

Valgus is a deformity involving oblique displacement of part of a limb away from the midline.

Outcome measures

Measure	IM Nails n=58 Participants Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=68 Participants Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Valgus of Over 5 Degrees	10 participants	20 participants

Adverse Events

IM Nails

Serious events: 3 serious events

Other events: 16 other events

Deaths: 0 deaths

Plate Fixation

Serious events: 4 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	IM Nails n=76 participants at risk Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=80 participants at risk Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Gastrointestinal disorders Subject expired due to cancer	1.3% 1/76 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	0.00% 0/80 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Cardiac disorders Subject expired due to cardiac arrest	0.00% 0/76 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	2.5% 2/80 • Number of events 2 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Cardiac disorders Subject expired due to unknown reason	1.3% 1/76 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	0.00% 0/80 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Musculoskeletal and connective tissue disorders Nonunion	1.3% 1/76 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	2.5% 2/80 • Number of events 2 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Other adverse events

Measure	IM Nails n=76 participants at risk Reamed, Interlocking Intramedullary Nail - Randomized treatment reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair	Plate Fixation n=80 participants at risk Locking Periarticular Plate - Randomized Treatment locking periarticular plate: Standard of care device for femur fractures
Musculoskeletal and connective tissue disorders Painful Implant	10.5% 8/76 • Number of events 8 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	8.8% 7/80 • Number of events 7 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Cardiac disorders Pulmonary Embolism	2.6% 2/76 • Number of events 2 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	1.2% 1/80 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Construct loosening	5.3% 4/76 • Number of events 4 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	0.00% 0/80 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Deep Vein Thrombosis	0.00% 0/76 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	2.5% 2/80 • Number of events 2 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Infection	3.9% 3/76 • Number of events 3 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	2.5% 2/80 • Number of events 2 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Fractured Implant	0.00% 0/76 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	1.2% 1/80 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Hardware Irritation	0.00% 0/76 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	1.2% 1/80 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months
Surgical and medical procedures Contralateral TKA	1.3% 1/76 • Number of events 1 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months	0.00% 0/80 • 2 weeks, 6 weeks, 3 months, 6 months, 12 months

Additional Information

Paul Tornetta III, MD

Boston Medical Center

Phone: 617-414-6295

Email: paul.tornetta@bmc.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place