Trial Outcomes & Findings for A Multicenter Randomized Trial Comparing IM Nails and Plate Fixation in Proximal Tibial Fractures (NCT NCT00429585)

NCT ID: NCT00429585

Last Updated: 2021-11-02

Results Overview

The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 108 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2021-11-02

Participant Flow

9 participants were enrolled but were not randomized. Of those 9, 6 were found ineligible after consent and 3 withdrew consent prior to randomization.

Participant milestones

Measure	Randomized Treatment - Nail Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Overall Study STARTED	52	47
Overall Study COMPLETED	22	27
Overall Study NOT COMPLETED	30	20

Reasons for withdrawal

Measure	Randomized Treatment - Nail Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Overall Study Death	1	0
Overall Study Lost to Follow-up	27	20
Overall Study Physician Decision	2	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Randomized Treatment - Nail n=52 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=47 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate	Total n=99 Participants Total of all reporting groups
Age, Continuous	43 years n=52 Participants	48 years n=47 Participants	46 years n=99 Participants
Sex: Female, Male Female	12 Participants n=52 Participants	11 Participants n=47 Participants	23 Participants n=99 Participants
Sex: Female, Male Male	40 Participants n=52 Participants	36 Participants n=47 Participants	76 Participants n=99 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	52 participants n=52 Participants	47 participants n=47 Participants	99 participants n=99 Participants

PRIMARY outcome

Timeframe: 3 months

The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.

Outcome measures

Measure	Randomized Treatment - Nail n=46 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Participants' Quality of Life at 3 Months	0.60 score on a scale Standard Deviation 0.24	0.59 score on a scale Standard Deviation 0.20

PRIMARY outcome

Timeframe: 6 months

The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The lower the score the less quality of life problems.

Outcome measures

Measure	Randomized Treatment - Nail n=43 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Participants' Quality of Life at 6 Months	0.65 score on a scale Standard Deviation 0.19	0.72 score on a scale Standard Deviation 0.20

PRIMARY outcome

Timeframe: 12 months

The European Quality of Life Five Dimension (EQ-5D) Survey will be used to measure the participants' quality of life. The EQ-5D measures the subjects' overall state, including 5 domains: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The score is determined by a scale and grading systems that can range from 0.01 to 1.00. The higher the score the less quality of life problems.

Outcome measures

Measure	Randomized Treatment - Nail n=22 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=27 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Participants' Quality of Life at 12 Months	0.60 score on a scale Standard Deviation .24	0.775 score on a scale Standard Deviation 0.16

PRIMARY outcome

Timeframe: 3 months

Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.

Outcome measures

Measure	Randomized Treatment - Nail n=46 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Injury Related Limitations and Concerns at 3 Months	40.25 score on a scale Standard Deviation 19.74	40.11 score on a scale Standard Deviation 16.28

PRIMARY outcome

Timeframe: 6 months

Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less injury related limitations and bother.

Outcome measures

Measure	Randomized Treatment - Nail n=43 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Injury Related Limitations and Concerns at 6 Months	32.19 score on a scale Standard Deviation 18.70	27.70 score on a scale Standard Deviation 18.58

PRIMARY outcome

Timeframe: 12 month follow-up

Participant limitations and bother from the injury will be assessed using the Short Musculoskeletal Function Assessment (SMFA).This survey asks the subject 46 questions, they are broken up into 2 parts. Part 1 relates to the difficulty/limitations the subject has related to their injury. Part 2 is how much the subject is bothered by this injury. Subjects provide score on a scale of 1 (no difficulty/bother) to 5 (highly difficult/bothered). The scoring range is between 0-100. The lower the score the less difficulty and bother.

Outcome measures

Measure	Randomized Treatment - Nail n=22 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=27 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Injury Related Limitations and Concerns at 12 Months	34.20 score on a scale Standard Deviation 20.93	23.51 score on a scale Standard Deviation 19.35

SECONDARY outcome

Timeframe: 12 months

A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays.

Outcome measures

Measure	Randomized Treatment - Nail n=22 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=27 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Number of Participants With Fracture Nonunions	4 Participants	5 Participants

SECONDARY outcome

Timeframe: 6 months

A superficial infection is an infection that occurs at the wound only. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

Outcome measures

Measure	Randomized Treatment - Nail n=43 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Number of Participants With Superficial Infections	0 Participants	2 Participants

SECONDARY outcome

Timeframe: 6 months

A deep infection is an infection occurring at the site of the nail or plate. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

Outcome measures

Measure	Randomized Treatment - Nail n=43 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Number of Participants With Deep Infections	3 Participants	1 Participants

SECONDARY outcome

Timeframe: 6 months

Compartment syndrome is a painful condition that occurs when pressure within the muscles builds to dangerous levels. Participants are monitored during clinical exams throughout the 12 month follow up appointments and medical records are reviewed.

Outcome measures

Measure	Randomized Treatment - Nail n=43 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=38 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Number of Participants With Compartment Syndrome	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Malunion is when a broken bone heals in an abnormal position. In this case, more than a 5 degree angle varus (curving into) or valgus (curving away). This is determined by a review of the participants' medical records and x-rays.

Outcome measures

Measure	Randomized Treatment - Nail n=22 Participants Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=27 Participants Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Number of Participants With Malunion (>5 Degrees Varus/Valgus)	3 Participants	3 Participants

Adverse Events

Randomized Treatment - Nail

Serious events: 4 serious events

Other events: 16 other events

Deaths: 1 deaths

Randomized Treatment - Plate

Serious events: 2 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Measure	Randomized Treatment - Nail n=52 participants at risk Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=47 participants at risk Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Surgical and medical procedures Patient fall	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Fracture	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	2.1% 1/47 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Musculoskeletal and connective tissue disorders Osteoporosis	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/52 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	2.1% 1/47 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Cardiac disorders Death	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.

Other adverse events

Measure	Randomized Treatment - Nail n=52 participants at risk Randomized Treatment - Nail reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail	Randomized Treatment - Plate n=47 participants at risk Randomized Treatment - Plate locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Surgical and medical procedures Painful Implant	3.8% 2/52 • Number of events 2 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Infections and infestations Infection	5.8% 3/52 • Number of events 3 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	6.4% 3/47 • Number of events 3 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Nonunion	7.7% 4/52 • Number of events 4 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	10.6% 5/47 • Number of events 5 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Malunion	5.8% 3/52 • Number of events 3 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	6.4% 3/47 • Number of events 3 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Wound Breakdown Right Proximal Tibia Surgical Site	3.8% 2/52 • Number of events 2 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Anterior compartment not functional	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Delayed Union	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures Peripheral Nerve Injury	0.00% 0/52 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	4.3% 2/47 • Number of events 2 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.
Surgical and medical procedures DVT	1.9% 1/52 • Number of events 1 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.	0.00% 0/47 • 6 years Adverse event information was collected during clinical followup appointments through questionnaires/surveys.

Additional Information

Paul Tornetta, 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