Tibial Fractures
Conditions
Keywords
tibia fracture, proximal tibia, interlocking intramedullary nail, locking periarticular plate, open reduction, internal fixation
Brief summary
This study looks at two types of surgical treatments and hopes to answer the question: which is the best way to surgically treat a proximal tibia fracture? Both procedures being studied are standard of care (used routinely) and use FDA approved devices. All medical and surgical treatment will be the same for participants as non-participants.
Detailed description
The study is a multicenter randomized controlled trial in which individuals sustaining a fracture of the proximal metaphysis of the tibia will be operatively managed by one of two strategies. The first strategy involves fixation of the fracture with a reamed, interlocking intramedullary nail (Nail Group). The second treatment strategy involves open reduction and internal fixation of the fracture with a locking periarticular plate (Plate Group). The null hypothesis of the study is that there will be no difference in the two groups with respect to the primary and secondary outcome measures. To the degree possible, patients in the two groups will receive post-operative care according to the same standards and protocols.
Interventions
Standard of care device for tibia fracture repair; Randomized Treatment - Nail
Standard of care device for tibia fracture repair; Randomized Treatment - Plate
Sponsors
Orthopaedic Trauma Association
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Skeletally mature, * Extra-articular fracture of the proximal tibia extending into the metaphyseal with or without intra-articular extension not requiring open reduction with complete anteroposterior (AP) and lateral radiographs, * Major fracture line not closer than 4cm from the proximal tibial articular surface * Fracture requiring operative treatment amenable to either IM nail or plate * Surgeon agreed to randomize patient * Informed consent obtained * Patient is English speaking
Exclusion criteria
* Tibial shaft fractures not amenable to intramedullary nailing (i.e.fracture is less than 4 cm from joint surface), * Fracture of the proximal tibia with intraarticular extension requiring open reduction, * Known metabolic bone disease * Separate displaced tibial tubercle fragment, * Soft tissue injuries compromising treatment method with nail,plate or both. * Fractures with vascular injury (Gustillo Type IIIC injury) requiring repair, * Compartment syndrome of the leg diagnosed preoperatively, * Pathological fractures, * Retained hardware or existing deformity in the affected limb that would complicate IM nailing,plating or both, * Symptomatic knee arthritis. * Surgical delay greater than 3 weeks for closed fractures or 24 hours for open fractures, * Immunocompromised, * Unable to comply with postoperative rehabilitation protocols or instructions (i.e. head injured or mentally impaired), * Current or impending incarceration, * Unlikely to follow-up in surgeon's estimation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Injury Related Limitations and Concerns at 12 Months | 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. |
| Participants' Quality of Life at 3 Months | 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. |
| Participants' Quality of Life at 6 Months | 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. |
| Participants' Quality of Life at 12 Months | 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. |
| Injury Related Limitations and Concerns at 3 Months | 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. |
| Injury Related Limitations and Concerns at 6 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Superficial Infections | 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. |
| Number of Participants With Deep Infections | 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. |
| Number of Participants With Compartment Syndrome | 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. |
| Number of Participants With Malunion (>5 Degrees Varus/Valgus) | 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. |
| Number of Participants With Fracture Nonunions | 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. |
Countries
Canada, United States
Participant flow
Pre-assignment details
9 participants were enrolled but were not randomized. Of those 9, 6 were found ineligible after consent and 3 withdrew consent prior to randomization.
Participants by arm
| Arm | Count |
|---|---|
| Randomized Treatment - Nail Randomized Treatment - Nail
reamed, interlocking intramedullary nail: Standard of care device for tibia fracture repair; Randomized Treatment - Nail | 52 |
| Randomized Treatment - Plate Randomized Treatment - Plate
locking periarticular plate: Standard of care device for tibia fracture repair; Randomized Treatment - Plate | 47 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Lost to Follow-up | 27 | 20 |
| Overall Study | Physician Decision | 2 | 0 |
Baseline characteristics
| Characteristic | Randomized Treatment - Plate | Total | Randomized Treatment - Nail |
|---|---|---|---|
| Age, Continuous | 48 years | 46 years | 43 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 47 participants | 99 participants | 52 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 Participants |
| Sex: Female, Male Male | 36 Participants | 76 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 52 | 0 / 47 |
| other Total, other adverse events | 16 / 52 | 13 / 47 |
| serious Total, serious adverse events | 4 / 52 | 2 / 47 |
Outcome results
Primary
Injury Related Limitations and Concerns at 12 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 difficulty and bother.
Time frame: 12 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Injury Related Limitations and Concerns at 12 Months | 34.20 score on a scale | Standard Deviation 20.93 |
| Randomized Treatment - Plate | Injury Related Limitations and Concerns at 12 Months | 23.51 score on a scale | Standard Deviation 19.35 |
Primary
Injury Related Limitations and Concerns at 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Injury Related Limitations and Concerns at 3 Months | 40.25 score on a scale | Standard Deviation 19.74 |
| Randomized Treatment - Plate | Injury Related Limitations and Concerns at 3 Months | 40.11 score on a scale | Standard Deviation 16.28 |
Primary
Injury Related Limitations and Concerns at 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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Injury Related Limitations and Concerns at 6 Months | 32.19 score on a scale | Standard Deviation 18.7 |
| Randomized Treatment - Plate | Injury Related Limitations and Concerns at 6 Months | 27.70 score on a scale | Standard Deviation 18.58 |
Primary
Participants' Quality of Life at 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.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Participants' Quality of Life at 12 Months | 0.60 score on a scale | Standard Deviation 0.24 |
| Randomized Treatment - Plate | Participants' Quality of Life at 12 Months | 0.775 score on a scale | Standard Deviation 0.16 |
Primary
Participants' Quality of Life at 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.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Participants' Quality of Life at 3 Months | 0.60 score on a scale | Standard Deviation 0.24 |
| Randomized Treatment - Plate | Participants' Quality of Life at 3 Months | 0.59 score on a scale | Standard Deviation 0.2 |
Primary
Participants' Quality of Life at 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.
Time frame: 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Randomized Treatment - Nail | Participants' Quality of Life at 6 Months | 0.65 score on a scale | Standard Deviation 0.19 |
| Randomized Treatment - Plate | Participants' Quality of Life at 6 Months | 0.72 score on a scale | Standard Deviation 0.2 |
Secondary
Number of Participants With Compartment Syndrome
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Treatment - Nail | Number of Participants With Compartment Syndrome | 1 Participants |
| Randomized Treatment - Plate | Number of Participants With Compartment Syndrome | 0 Participants |
Secondary
Number of Participants With Deep Infections
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Treatment - Nail | Number of Participants With Deep Infections | 3 Participants |
| Randomized Treatment - Plate | Number of Participants With Deep Infections | 1 Participants |
Secondary
Number of Participants With Fracture Nonunions
A nonunion is when a broken bone fails to heal. This is determined by a review of the participants' medical records and x-rays.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Treatment - Nail | Number of Participants With Fracture Nonunions | 4 Participants |
| Randomized Treatment - Plate | Number of Participants With Fracture Nonunions | 5 Participants |
Secondary
Number of Participants With Malunion (>5 Degrees Varus/Valgus)
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.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Treatment - Nail | Number of Participants With Malunion (>5 Degrees Varus/Valgus) | 3 Participants |
| Randomized Treatment - Plate | Number of Participants With Malunion (>5 Degrees Varus/Valgus) | 3 Participants |
Secondary
Number of Participants With Superficial Infections
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.
Time frame: 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Randomized Treatment - Nail | Number of Participants With Superficial Infections | 0 Participants |
| Randomized Treatment - Plate | Number of Participants With Superficial Infections | 2 Participants |