Fracture
Conditions
Keywords
Closed, unilateral, pilon
Brief summary
Patients who sustain broken ankles have a very high risk of developing arthritis soon after injury (within 2 years). This arthritis can cause increased pain and a decrease level of function, especially if the injury occurs at an early age. During and shortly after ankle injury, there is an inflammatory chemical process that takes place in the ankle that can cause damage to the cartilage in the ankle joint. The investigators want to use what is called Platelet Rich Plasma (PRP), which is produced from a small amount of the patient's own blood, to inject into the injured ankle to see if they can decrease the inflammation that happens after the injury and to see if they can decrease arthritis.
Detailed description
Patients who sustain broken ankles have a very high risk of developing arthritis soon after their injury (within 2 years). This arthritis can cause increased pain and decreased level of function, especially if the injury occurs at an early age. During and shortly after the ankle injury, there is an inflammatory chemical processes that take place in the ankle that can cause damage to the cartilage in the ankle joint. Currently the treatment for this injury is doing surgery is a two step process. When the patient has an ankle fracture, surgeons will stabilize the fracture with an external fixation device to allow ankle swelling to decrease which has been shown improve outcomes within a few hours. After about 10 days the patient will come back for their final surgery in which surgeons will open the ankle joint and make sure that the joint lines up and fix it with plates and screws. There is no intervention that is done with regards to the physiologic process that goes on inside the ankle joint when the ankle is injured. This is what the investigators intend to study. There is a very large destructive process that may contribute with the early development to arthritis. The investigators would like to see the effect of this inflammatory response with the addition of platelet rich plasma (PRP) which is produced from a small vial of the patient's own blood. PRP has been used safely in patients with osteoarthritis and has been shown to slow the progression and improve pain scores. PRP is made by spinning the patient's blood in a centrifuge which separates the blood cells from each other. The bloods cells that are anti-inflammatory in nature are taken and placed in another syringe. This is a blinded randomized control study. There will be two groups in which the patients will randomize into: PRP group, or Normal Saline Group. In both groups, the investigator's plan is to withdraw joint fluid from both the injured and uninjured ankle at the time of the first surgery as to analyze the joint fluid from both ankles. Participants who are randomized into the PRP group will receive PRP in the injured ankle at the time of the first surgery when the external fixator is placed. Participants who are randomized into the Normal Saline group will receive Normal Saline in the injured ankle at the time of the first surgery when the external fixator is placed. After 7-14 days the participant will return and have their second surgery for definitive fixation. At the time of surgery, joint fluid will again be taken out of the joint for analysis to see if the PRP decreased the anti-inflammatory cells decreased inflammation. After the second surgery the participant will be followed up in the clinic in a regular manner.
Interventions
BIOLOGICALArthrocentesis/PRP
PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation
Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation
Sponsors
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Closed unilateral pilon fracture
Exclusion criteria
* Patients who are younger than 18 years of age * Open pilon fracture * Patients with contralateral lower extremity injury * Patients unable to comply with the follow-up appointments * Patients who had previous ankle injury to the currently injured ankle * Patients who are pregnant * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | 2 weeks after external fixation | Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation |
| Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF) | 18 months after ORIF | Post-traumatic Osteoarthritis will be determined from whole-joint Magnetic Resonance Imaging (MRI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | 2 weeks after ORIF | The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain. |
| Patient Reported Outcomes (PROs) | 6 weeks after ORIF | The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain. |
Countries
United States
Participant flow
Pre-assignment details
Plan for total enrollment of n=40 with n=20 in the PRP arm and n=20 in the saline arm
Participants by arm
| Arm | Count |
|---|---|
| Platelet Rich Plasma At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. A needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected. Using the same needle, the PRP will be delivered into the joint.
Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of PRP. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.
Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of PRP, just an aspiration of both injured and uninjured ankles.
Arthrocentesis/PRP: PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation | 5 |
| Saline At the time of surgery, the participant will have both injured and uninjured ankles cleaned with surgical soap. An needle will be placed into the injured ankle joint and synovial fluid will be drawn out of the ankle and collected into a syringe. Using the same needle, the Saline will be delivered into the same arthrocentesis needle.
Next the uninjured ankle will have the same procedure as the injured ankle, except there will be no injection of Saline. There will only be a aspiration of synovial fluid from the uninjured ankle joint using a different clean needle.
Another aspiration of the synovial fluid will be done at the time of the second surgery in the same manner as before, except there will be no injection of Saline, just an aspiration of both injured and uninjured ankles.
Arthrocentesis/Saline: Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 4 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Total | Saline | Platelet Rich Plasma |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 5 Participants | 5 Participants |
| Age, Continuous | 44.47 years STANDARD_DEVIATION 15.43 | 48.88 years STANDARD_DEVIATION 17.97 | 39.66 years STANDARD_DEVIATION 11.77 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 6 Participants | 5 Participants |
| Region of Enrollment United States | 11 Participants | 6 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 1 Participants |
| Sex: Female, Male Male | 7 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 6 |
| other Total, other adverse events | 1 / 5 | 1 / 6 |
| serious Total, serious adverse events | 4 / 5 | 0 / 6 |
Outcome results
Primary
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation
Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation
Time frame: 2 weeks after external fixation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-13 | 0.47 pg/ml | Standard Deviation 0.656 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-1B | 1.62 pg/ml | Standard Deviation 1.079 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-8 | 2373.21 pg/ml | Standard Deviation 3787.668 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MCP-1 | 4290373 pg/ml | Standard Deviation 3708.968 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MIP-1A | 9.70 pg/ml | Standard Deviation 17.591 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-7 | 21182.40 pg/ml | Standard Deviation 19303.296 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MIP-1B | 28.26 pg/ml | Standard Deviation 46.006 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | TNF-A | 6.21 pg/ml | Standard Deviation 2.408 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | VEGF | 716.06 pg/ml | Standard Deviation 838.759 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-2 | 49985.40 pg/ml | Standard Deviation 24550.313 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-1 | 8482.56 pg/ml | Standard Deviation 6398.284 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-9 | 23974.72 pg/ml | Standard Deviation 36530.879 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | Prostaglandin E2 (PGE2) | 709.43 pg/ml | Standard Deviation 1165.492 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | Fractaline | 54.89 pg/ml | Standard Deviation 44.84 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | GRO-A | 2479.17 pg/ml | Standard Deviation 1560.321 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-10 | 37.87 pg/ml | Standard Deviation 31.249 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MCP-3 | 109.59 pg/ml | Standard Deviation 81.92 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | PDGF-AA | 763.67 pg/ml | Standard Deviation 770.151 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-1RA | 1759.51 pg/ml | Standard Deviation 1547.219 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | PDGF-ABBB | 3273.77 pg/ml | Standard Deviation 2439.361 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-2 | 0.28 pg/ml | Standard Deviation 0.378 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-4 | 0.00 pg/ml | Standard Deviation 0 |
| Platelet Rich Plasma | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-6 | 2161.64 pg/ml | Standard Deviation 2590.332 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-2 | 1.82 pg/ml | Standard Deviation 1.756 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-1RA | 2690.89 pg/ml | Standard Deviation 2015.254 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | Prostaglandin E2 (PGE2) | 411.76 pg/ml | Standard Deviation 646.284 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-13 | 0.35 pg/ml | Standard Deviation 0.341 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-8 | 2554.12 pg/ml | Standard Deviation 4199.522 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | Fractaline | 163.01 pg/ml | Standard Deviation 163.7 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MCP-1 | 4152.51 pg/ml | Standard Deviation 3541.933 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-6 | 2206.67 pg/ml | Standard Deviation 2584.125 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MIP-1A | 7.44 pg/ml | Standard Deviation 5.412 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | GRO-A | 2511.32 pg/ml | Standard Deviation 3171.135 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | PDGF-ABBB | 2246.71 pg/ml | Standard Deviation 3416.702 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MIP-1B | 23.11 pg/ml | Standard Deviation 10.392 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-10 | 71.38 pg/ml | Standard Deviation 58.7 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | TNF-A | 6.46 pg/ml | Standard Deviation 3.316 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-1B | 5.95 pg/ml | Standard Deviation 8.439 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | VEGF | 953.47 pg/ml | Standard Deviation 1077.999 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MCP-3 | 113.59 pg/ml | Standard Deviation 121.85 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-2 | 61667.25 pg/ml | Standard Deviation 6011.542 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | IL-4 | 9.08 pg/ml | Standard Deviation 20.303 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-1 | 10643.50 pg/ml | Standard Deviation 5011.581 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-7 | 43418.25 pg/ml | Standard Deviation 37425.332 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | PDGF-AA | 284.72 pg/ml | Standard Deviation 245.856 |
| Saline | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | MMP-9 | 7628.05 pg/ml | Standard Deviation 11921.451 |
Primary
Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF)
Post-traumatic Osteoarthritis will be determined from whole-joint Magnetic Resonance Imaging (MRI)
Time frame: 18 months after ORIF
Population: Only 2 subjects in the Saline group completed the MRI at 18 months after surgery. None of the subjects in the Platelet Rich Plasma (PRP) group completed the MRI
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Platelet Rich Plasma | Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF) | 0 Participants |
| Saline | Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF) | 1 Participants |
Secondary
Patient Reported Outcomes (PROs)
The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.
Time frame: 6 weeks after ORIF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | VAS Score | 5.50 score on a scale | Standard Deviation 6.36 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Total Score | 15.00 score on a scale | Standard Deviation 28.75 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 49.09 score on a scale | Standard Deviation 13.16 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Function Score | 0.00 score on a scale | Standard Deviation 0 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 27.47 score on a scale | Standard Deviation 11.34 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 15.00 score on a scale | Standard Deviation 21.213 |
| Saline | Patient Reported Outcomes (PROs) | VAS Score | 3.33 score on a scale | Standard Deviation 1.13 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 34.39 score on a scale | Standard Deviation 2.6 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 41.48 score on a scale | Standard Deviation 5.79 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 25.00 score on a scale | Standard Deviation 5.774 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Total Score | 21.213 score on a scale | Standard Deviation 8.808 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Function Score | 3.75 score on a scale | Standard Deviation 3.775 |
Secondary
Patient Reported Outcomes (PROs)
The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.
Time frame: 12 months after ORIF
Population: Only 2 subjects in the saline group completed the PRO for the 12 months follow up time-frame. All the subjects in the PRP group were lost to follow up
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Saline | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 51.14 score on a scale | Standard Deviation 5.9 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 41.13 score on a scale | Standard Deviation 24.88 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 30.00 score on a scale | Standard Deviation 0 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Total Score | 46.50 score on a scale | Standard Deviation 2.121 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Function Score | 16.50 score on a scale | Standard Deviation 2.121 |
| Saline | Patient Reported Outcomes (PROs) | VAS Score | 1.4250 score on a scale | Standard Deviation 0.60104 |
Secondary
Patient Reported Outcomes (PROs)
The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.
Time frame: 12 weeks after ORIF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 37.210 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 60.1 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 40.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Total Score | 45.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Function Score | 5.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | VAS Score | 1.000 score on a scale | — |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Function Score | 9.25 score on a scale | Standard Deviation 7.042 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 42.11 score on a scale | Standard Deviation 8.4 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Total Score | 39.25 score on a scale | Standard Deviation 11.383 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 48.67 score on a scale | Standard Deviation 13.24 |
| Saline | Patient Reported Outcomes (PROs) | VAS Score | 1.7625 score on a scale | Standard Deviation 1.017 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 30.00 score on a scale | Standard Deviation 8.16 |
Secondary
Patient Reported Outcomes (PROs)
The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.
Time frame: 6 months after ORIF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Total Score | 45.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 61.18 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Function Score | 15.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 30.00 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | VAS Score | 1.000 score on a scale | — |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 50.62 score on a scale | — |
| Saline | Patient Reported Outcomes (PROs) | VAS Score | 3.87 score on a scale | Standard Deviation 2.5 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Physical Score | 46.54 score on a scale | Standard Deviation 8.91 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Pain Score | 25.00 score on a scale | Standard Deviation 7.071 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Total Score | 39.50 score on a scale | Standard Deviation 10.607 |
| Saline | Patient Reported Outcomes (PROs) | AOFAS Function Score | 14.50 score on a scale | Standard Deviation 3.536 |
| Saline | Patient Reported Outcomes (PROs) | SF-12 Mental Score | 39.29 score on a scale | Standard Deviation 7.27 |
Secondary
Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS)
The AOFAS is a standardized evaluation of the clinical status of the ankle-hindfoot. In uses both subjective & objective information. Patients report their pain (40 possible points), physicians assess alignment (10 possible points) & the patient and physician work together to complete the function portion (50 possible points). Total scores range from 0-100, with healthy ankles receiving 100. The SF-12 assesses the impact of health on an individual's everyday life. The 2 scores are reported from the SF12 - a mental componet score (MCS) and a physical component score (PCS). The scores may be reported as Z-scores (difference compared to the population average, measured in standard deviations (SD). The US average PCS-12 and MCS are both 50 points. The US population SD is 10 points. So each 10 increment of 10 point or above or below 50, corresponds to 1 SD away from the average. VAS measures the amount of pain a patient feels on a continuum from 0=no pain to 100=worst pain.
Time frame: 2 weeks after ORIF
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | SF-12 Mental Score | 58.06 score on a scale | Standard Deviation 12.24 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Function Score | 15.00 score on a scale | Standard Deviation 21.213 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Pain Score | 0.00 score on a scale | Standard Deviation 0 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Total Score | 15.00 score on a scale | Standard Deviation 21.213 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | VAS Score | 5.12 score on a scale | Standard Deviation 4.66 |
| Platelet Rich Plasma | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | SF-12 Physical Score | 24.11 score on a scale | Standard Deviation 1.95 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | VAS Score | 5.86 score on a scale | Standard Deviation 2.87 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Total Score | 15.00 score on a scale | Standard Deviation 10 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Function Score | 19.50 score on a scale | Standard Deviation 4.933 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | SF-12 Physical Score | 28.96 score on a scale | Standard Deviation 4.62 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | SF-12 Mental Score | 48.97 score on a scale | Standard Deviation 10.47 |
| Saline | Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS) | AOFAS Pain Score | 6.60 score on a scale | Standard Deviation 7.092 |