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Completed

NCT Number: NCT02481869

Platelet Rich Plasma Injection in Pilon Fractures

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.

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Key information

Conditions

Fracture Fractures, Bone Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arthrocentesis/PRP

Biological

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

Other names: platelet-rich plasma

Arthrocentesis/Saline

Drug

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

Other names: saline

Primary outcomes

  1. Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation

    Time frame: 2 weeks after external fixation

    Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation

  2. Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF)

    Time frame: 18 months after ORIF

    Post-traumatic Osteoarthritis will be determined from whole-joint Magnetic Resonance Imaging (MRI)

Secondary outcomes

  1. Patient Reported Outcomes (PROs): Ankle-Hindfoot Scale (AOFAS), Short Form Health Survey (SF-12), and Visual Analog Scale (VAS)

    Time frame: 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.

  2. Patient Reported Outcomes (PROs)

    Time frame: 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.

  3. Patient Reported Outcomes (PROs)

    Time frame: 12 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.

  4. Patient Reported Outcomes (PROs)

    Time frame: 6 months 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.

  5. Patient Reported Outcomes (PROs)

    Time frame: 12 months 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Official study title

Does Early Platelet Rich Plasma Injection Decrease the Risk of Post-traumatic Arthritis in Pilon Fractures Undergoing Two-staged Open Reduction With Internal Fixation?

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Jun 25, 2015
Registry last updated
Feb 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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