FractureNCT02481869
Platelet Rich Plasma Injection in Pilon Fractures
A study testing Arthrocentesis/PRP and Arthrocentesis/Saline in people with Fracture, run by University of Missouri-Columbia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fracture
- What is being tested?
- Arthrocentesis/PRP and Arthrocentesis/Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Closed unilateral pilon fracture
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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?
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.
Read the 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.
- Conditions
- Fracture
- Being tested
- Arthrocentesis/PRP, Arthrocentesis/Saline
- Keywords
- Closed, unilateral, pilon
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arthrocentesis/PRPBiological
Also called platelet-rich plasma
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
Arthrocentesis/SalineDrug
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| Arthrocentesis/PRP | Active comparator | 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 PRP 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 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. Receives: Biological: Arthrocentesis/PRP |
| Arthrocentesis/Saline | Placebo comparator | 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. Receives: Drug: Arthrocentesis/Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation
Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation
Measured: 2 weeks after external fixation
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)
Measured: 18 months after ORIF
Secondary outcomes (5)
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.
Measured: 2 weeks after ORIF
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.
Measured: 6 weeks after ORIF
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.
Measured: 12 weeks after ORIF
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.
Measured: 6 months after ORIF
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.
Measured: 12 months after ORIF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2019
- Study completionNov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for FractureStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brett Crist, University of Missouri-Columbia
- Investigators
- Brett D Crist, MD, Principal investigator, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02481869
- Sponsor's protocol ID
- 2002117
- Status last verified
- Jan 2021
- First submitted
- 11 Jun 2015
- Last updated
- 5 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Marsh JL, Weigel DP, Dirschl DR. Tibial plafond fractures. How do these ankles function over time? J Bone Joint Surg Am. 2003 Feb;85(2):287-95.
PubMed 12571307Martin JA, Buckwalter JA. Post-traumatic osteoarthritis: the role of stress induced chondrocyte damage. Biorheology. 2006;43(3,4):517-21.
PubMed 16912423Green DM, Noble PC, Ahuero JS, Birdsall HH. Cellular events leading to chondrocyte death after cartilage impact injury. Arthritis Rheum. 2006 May;54(5):1509-17. doi: 10.1002/art.21812.
PubMed 16649187Guilak F, Fermor B, Keefe FJ, Kraus VB, Olson SA, Pisetsky DS, Setton LA, Weinberg JB. The role of biomechanics and inflammation in cartilage injury and repair. Clin Orthop Relat Res. 2004 Jun;(423):17-26. doi: 10.1097/01.blo.0000131233.83640.91.
PubMed 15232421Franklin SP, Cook JL. Prospective trial of autologous conditioned plasma versus hyaluronan plus corticosteroid for elbow osteoarthritis in dogs. Can Vet J. 2013 Sep;54(9):881-4.
PubMed 24155495Waters NP, Stoker AM, Carson WL, Pfeiffer FM, Cook JL. Biomarkers affected by impact velocity and maximum strain of cartilage during injury. J Biomech. 2014 Sep 22;47(12):3185-95. doi: 10.1016/j.jbiomech.2014.06.015. Epub 2014 Jun 21.
PubMed 25005436Waters NP, Stoker AM, Pfeiffer FM, Cook JL. Biomarkers Affected by Impact Severity during Osteochondral Injury. J Knee Surg. 2015 Jun;28(3):191-200. doi: 10.1055/s-0034-1376329. Epub 2014 May 23.
PubMed 24858662Garner BC, Stoker AM, Kuroki K, Evans R, Cook CR, Cook JL. Using animal models in osteoarthritis biomarker research. J Knee Surg. 2011 Dec;24(4):251-64. doi: 10.1055/s-0031-1297361.
PubMed 22303754Thomas TP, Anderson DD, Mosqueda TV, Van Hofwegen CJ, Hillis SL, Marsh JL, Brown TD. Objective CT-based metrics of articular fracture severity to assess risk for posttraumatic osteoarthritis. J Orthop Trauma. 2010 Dec;24(12):764-9. doi: 10.1097/BOT.0b013e3181d7a0aa.
PubMed 21076249
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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?
- ClinicalTrials.gov ID
- NCT02481869
- Acronym / sponsor ID
- 2002117
- Conditions
- Fracture
- Keywords
- Closed, unilateral, pilon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- Jun 2015 (actual)
- Primary completion
- Nov 2019 (actual)
- Study completion
- Nov 2019 (actual)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Posted 5 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthrocentesis/PRP | Active comparator | Biological: Arthrocentesis/PRPAt 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 PRP 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 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/Saline | Placebo comparator | Drug: Arthrocentesis/SalineAt 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Closed unilateral pilon fracture
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arthrocentesis/PRPAlso: platelet-rich plasmaPRP (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 | Biological | Arthrocentesis/PRP |
| Arthrocentesis/SalineAlso: salineControl (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 | Drug | Arthrocentesis/Saline |
Primary outcome
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
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)
5 secondary outcomes
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
Patient Reported Outcomes (PROs)
Time frame: 6 weeks after ORIF
Patient Reported Outcomes (PROs)
Time frame: 12 weeks after ORIF
Patient Reported Outcomes (PROs)
Time frame: 6 months after ORIF
Patient Reported Outcomes (PROs)
Time frame: 12 months after ORIF
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12571307Marsh JL, Weigel DP, Dirschl DR. Tibial plafond fractures. How do these ankles function over time? J Bone Joint Surg Am. 2003 Feb;85(2):287-95.
- Background: PubMed 16912423Martin JA, Buckwalter JA. Post-traumatic osteoarthritis: the role of stress induced chondrocyte damage. Biorheology. 2006;43(3,4):517-21.
- Background: PubMed 16649187Green DM, Noble PC, Ahuero JS, Birdsall HH. Cellular events leading to chondrocyte death after cartilage impact injury. Arthritis Rheum. 2006 May;54(5):1509-17. doi: 10.1002/art.21812.
- Background: PubMed 15232421Guilak F, Fermor B, Keefe FJ, Kraus VB, Olson SA, Pisetsky DS, Setton LA, Weinberg JB. The role of biomechanics and inflammation in cartilage injury and repair. Clin Orthop Relat Res. 2004 Jun;(423):17-26. doi: 10.1097/01.blo.0000131233.83640.91.
- Background: PubMed 24155495Franklin SP, Cook JL. Prospective trial of autologous conditioned plasma versus hyaluronan plus corticosteroid for elbow osteoarthritis in dogs. Can Vet J. 2013 Sep;54(9):881-4.
- Background: PubMed 25005436Waters NP, Stoker AM, Carson WL, Pfeiffer FM, Cook JL. Biomarkers affected by impact velocity and maximum strain of cartilage during injury. J Biomech. 2014 Sep 22;47(12):3185-95. doi: 10.1016/j.jbiomech.2014.06.015. Epub 2014 Jun 21.
- Background: PubMed 24858662Waters NP, Stoker AM, Pfeiffer FM, Cook JL. Biomarkers Affected by Impact Severity during Osteochondral Injury. J Knee Surg. 2015 Jun;28(3):191-200. doi: 10.1055/s-0034-1376329. Epub 2014 May 23.
- Background: PubMed 22303754Garner BC, Stoker AM, Kuroki K, Evans R, Cook CR, Cook JL. Using animal models in osteoarthritis biomarker research. J Knee Surg. 2011 Dec;24(4):251-64. doi: 10.1055/s-0031-1297361.
- Background: PubMed 21076249Thomas TP, Anderson DD, Mosqueda TV, Van Hofwegen CJ, Hillis SL, Marsh JL, Brown TD. Objective CT-based metrics of articular fracture severity to assess risk for posttraumatic osteoarthritis. J Orthop Trauma. 2010 Dec;24(12):764-9. doi: 10.1097/BOT.0b013e3181d7a0aa.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brett D Crist, MD principal investigator
University of Missouri-Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arthrocentesis/PRP and Arthrocentesis/Saline in people with Fracture, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation (time frame: 2 weeks after external fixation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02481869, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2021.