Platelet Rich Plasma Injection in Pilon Fractures
| Status: | Recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 7/25/2018 |
| Start Date: | June 2015 |
| End Date: | July 2021 |
| Contact: | Brett D Crist, MD |
| Email: | cristb@health.missouri.edu |
| Phone: | 5738826562 |
Does Early Platelet Rich Plasma Injection Decrease the Risk of Post-traumatic Arthritis in Pilon Fractures Undergoing Two-staged Open Reduction With Internal Fixation?
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.
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.
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.
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.
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
We found this trial at
1
site
Columbia, Missouri 65211
(573) 882-2121
Principal Investigator: Brett D Crist, MD
University of Missouri T he University of Missouri was founded in 1839 in Columbia, Mo.,...
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