Fracture Clinical Trial
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?
NCT number | NCT02481869 |
Other study ID # | 2002117 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2015 |
Est. completion date | November 2019 |
Verified date | January 2021 |
Source | University of Missouri-Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 11 |
Est. completion date | November 2019 |
Est. primary completion date | November 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Missouri | Columbia | Missouri |
Lead Sponsor | Collaborator |
---|---|
University of Missouri-Columbia |
United States,
Franklin 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. — View Citation
Garner 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. Review. — View Citation
Green 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. — View Citation
Guilak 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. Review. — View Citation
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. — View Citation
Martin JA, Buckwalter JA. Post-traumatic osteoarthritis: the role of stress induced chondrocyte damage. Biorheology. 2006;43(3,4):517-21. — View Citation
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Waters 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. — View Citation
Waters 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation | Inflammatory Biomarkers will be measured (pg/ml) at the time of definitive Fixation | 2 weeks after external fixation | |
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) | 18 months after ORIF | |
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. |
2 weeks after ORIF | |
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. |
6 weeks after ORIF | |
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. |
12 weeks after ORIF | |
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. |
6 months after ORIF | |
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. |
12 months after ORIF |
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