Femoral Fractures
Conditions
Keywords
distal femur, femur fracture
Brief summary
This study looks at two (2) types of surgical treatments and hopes to answer the question, which is the best way to surgically treat a distal femur 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 randomized controlled multicenter trial in which individuals sustaining a fracture of the supracondylar (metaphyseal) region of the distal femur 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 femur fracture repair
Standard of care device for femur fractures
Sponsors
Boston Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Skeletally mature * Fracture of the metaphyseal distal femur with or without intra-articular extension and with or without a TKA * Fracture requiring operative treatment amenable to either IM nail or plate * Informed consent obtained * Patient is English speaking
Exclusion criteria
* Fracture of the metaphyseal distal femur with intra-articular communition, * Fracture with vascular injury (Gustillo Type IIIC injury) requiring repair, * Pathological fracture, * Known metabolic bone disease, * Contralateral distal femur fractures (bilateral injury) or ipsilateral lower extremity injury that would compromise function of the knee * Retained hardware or existing deformity in the affected limb that would complicate IM nailing or plating * Symptomatic knee arthritis * Soft tissue injuries compromising either treatment method with nail or plate * 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 |
|---|---|---|
| EQ-5D | 3 months, 6 months, 12 months | 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. |
| Short Musculoskeletal Functional Assessment (SMFA) Score | 3 months, 6 months, 12 months | 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. |
| EQ Index | 3 months, 6 months, 12 months | 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. |
| SMFA - Bother Index | 3 months, 6 months, 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Valgus of Over 5 Degrees | 12 months | Valgus is a deformity involving oblique displacement of part of a limb away from the midline. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| IM Nails Reamed, Interlocking Intramedullary Nail - Randomized treatment
reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair | 58 |
| Plate Fixation Locking Periarticular Plate - Randomized Treatment
locking periarticular plate: Standard of care device for femur fractures | 68 |
| Total | 126 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 4 | 0 |
| Overall Study | Lost to Follow-up | 24 | 31 |
| Overall Study | Physician Decision | 6 | 3 |
| Overall Study | Withdrawal by Subject | 2 | 5 |
Baseline characteristics
| Characteristic | IM Nails | Plate Fixation | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 16 Participants | 20 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 48 Participants | 89 Participants |
| Age, Continuous | 51 years | 53 years | 51 years |
| Sex: Female, Male Female | 22 Participants | 33 Participants | 55 Participants |
| Sex: Female, Male Male | 36 Participants | 35 Participants | 71 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 76 | 14 / 80 |
| serious Total, serious adverse events | 3 / 76 | 4 / 80 |
Outcome results
Primary
EQ-5D
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IM Nails | EQ-5D | 3 months | 69.23 units on a scale | Standard Deviation 17.64 |
| IM Nails | EQ-5D | 6 months | 74.24 units on a scale | Standard Deviation 13.65 |
| IM Nails | EQ-5D | 12 months | 79.07 units on a scale | Standard Deviation 16.01 |
| Plate Fixation | EQ-5D | 3 months | 72.81 units on a scale | Standard Deviation 18.85 |
| Plate Fixation | EQ-5D | 6 months | 73.04 units on a scale | Standard Deviation 24.11 |
| Plate Fixation | EQ-5D | 12 months | 71.9 units on a scale | Standard Deviation 23.34 |
Primary
EQ Index
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IM Nails | EQ Index | 3 months | 0.63 units on a scale | Standard Deviation 0.23 |
| IM Nails | EQ Index | 6 months | 0.73 units on a scale | Standard Deviation 0.27 |
| IM Nails | EQ Index | 12 months | 0.76 units on a scale | Standard Deviation 0.23 |
| Plate Fixation | EQ Index | 3 months | 0.59 units on a scale | Standard Deviation 0.19 |
| Plate Fixation | EQ Index | 12 months | 0.70 units on a scale | Standard Deviation 0.17 |
| Plate Fixation | EQ Index | 6 months | 0.68 units on a scale | Standard Deviation 0.2 |
Primary
Short Musculoskeletal Functional Assessment (SMFA) Score
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IM Nails | Short Musculoskeletal Functional Assessment (SMFA) Score | 3 months | 38.76 units on a scale | Standard Deviation 19.21 |
| IM Nails | Short Musculoskeletal Functional Assessment (SMFA) Score | 6 months | 29.82 units on a scale | Standard Deviation 18.79 |
| IM Nails | Short Musculoskeletal Functional Assessment (SMFA) Score | 12 months | 22.18 units on a scale | Standard Deviation 15.54 |
| Plate Fixation | Short Musculoskeletal Functional Assessment (SMFA) Score | 3 months | 41.58 units on a scale | Standard Deviation 19.17 |
| Plate Fixation | Short Musculoskeletal Functional Assessment (SMFA) Score | 6 months | 31.92 units on a scale | Standard Deviation 22.22 |
| Plate Fixation | Short Musculoskeletal Functional Assessment (SMFA) Score | 12 months | 26.83 units on a scale | Standard Deviation 23.18 |
Primary
SMFA - Bother Index
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IM Nails | SMFA - Bother Index | 3 months | 40.46 units on a scale | Standard Deviation 21.95 |
| IM Nails | SMFA - Bother Index | 6 months | 28.23 units on a scale | Standard Deviation 18.34 |
| IM Nails | SMFA - Bother Index | 12 months | 22.97 units on a scale | Standard Deviation 19.12 |
| Plate Fixation | SMFA - Bother Index | 3 months | 36.75 units on a scale | Standard Deviation 18.85 |
| Plate Fixation | SMFA - Bother Index | 6 months | 29.94 units on a scale | Standard Deviation 24.34 |
| Plate Fixation | SMFA - Bother Index | 12 months | 28.93 units on a scale | Standard Deviation 28.68 |
Secondary
Valgus of Over 5 Degrees
Valgus is a deformity involving oblique displacement of part of a limb away from the midline.
Time frame: 12 months
Population: 160 subjects were enrolled, but due to patient withdrawal or incomplete data from sites, only 126 subjects were followed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IM Nails | Valgus of Over 5 Degrees | 10 participants |
| Plate Fixation | Valgus of Over 5 Degrees | 20 participants |