Trial Outcomes & Findings for Platelet Rich Plasma Injection in Pilon Fractures (NCT NCT02481869)

NCT ID: NCT02481869

Last Updated: 2021-02-05

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

2 weeks after external fixation

Results posted on

2021-02-05

Participant Flow

Plan for total enrollment of n=40 with n=20 in the PRP arm and n=20 in the saline arm

Participant milestones

Participant milestones
Measure	Platelet Rich Plasma 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. 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-s	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
Overall Study STARTED	5	6
Overall Study COMPLETED	0	2
Overall Study NOT COMPLETED	5	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Platelet Rich Plasma 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. 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-s	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
Overall Study Lost to Follow-up	3	4
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

Platelet Rich Plasma Injection in Pilon Fractures

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Platelet Rich Plasma n=5 Participants 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	Saline n=6 Participants 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	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	39.66 years STANDARD_DEVIATION 11.77 • n=5 Participants	48.88 years STANDARD_DEVIATION 17.97 • n=7 Participants	44.47 years STANDARD_DEVIATION 15.43 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks after external fixation

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

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma n=5 Participants 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. Using the same needle, the PRP will be delivered. 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	Saline n=6 Participants 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
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MIP-1A	9.70 pg/ml Standard Deviation 17.591	7.44 pg/ml Standard Deviation 5.412
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation Fractaline	54.89 pg/ml Standard Deviation 44.84	163.01 pg/ml Standard Deviation 163.70
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation GRO-A	2479.17 pg/ml Standard Deviation 1560.321	2511.32 pg/ml Standard Deviation 3171.135
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-10	37.87 pg/ml Standard Deviation 31.249	71.38 pg/ml Standard Deviation 58.70
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MCP-3	109.59 pg/ml Standard Deviation 81.920	113.59 pg/ml Standard Deviation 121.850
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation PDGF-AA	763.67 pg/ml Standard Deviation 770.151	284.72 pg/ml Standard Deviation 245.856
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-13	0.47 pg/ml Standard Deviation 0.656	0.35 pg/ml Standard Deviation 0.341
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation PDGF-ABBB	3273.77 pg/ml Standard Deviation 2439.361	2246.71 pg/ml Standard Deviation 3416.702
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-1RA	1759.51 pg/ml Standard Deviation 1547.219	2690.89 pg/ml Standard Deviation 2015.254
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-1B	1.62 pg/ml Standard Deviation 1.079	5.95 pg/ml Standard Deviation 8.439
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-2	0.28 pg/ml Standard Deviation 0.378	1.82 pg/ml Standard Deviation 1.756
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-4	0.00 pg/ml Standard Deviation 0.000	9.08 pg/ml Standard Deviation 20.303
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-6	2161.64 pg/ml Standard Deviation 2590.332	2206.67 pg/ml Standard Deviation 2584.125
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation IL-8	2373.21 pg/ml Standard Deviation 3787.668	2554.12 pg/ml Standard Deviation 4199.522
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MCP-1	4290373 pg/ml Standard Deviation 3708.968	4152.51 pg/ml Standard Deviation 3541.933
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MIP-1B	28.26 pg/ml Standard Deviation 46.006	23.11 pg/ml Standard Deviation 10.392
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation TNF-A	6.21 pg/ml Standard Deviation 2.408	6.46 pg/ml Standard Deviation 3.316
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation VEGF	716.06 pg/ml Standard Deviation 838.759	953.47 pg/ml Standard Deviation 1077.999
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MMP-2	49985.40 pg/ml Standard Deviation 24550.313	61667.25 pg/ml Standard Deviation 6011.542
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MMP-1	8482.56 pg/ml Standard Deviation 6398.284	10643.50 pg/ml Standard Deviation 5011.581
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MMP-7	21182.40 pg/ml Standard Deviation 19303.296	43418.25 pg/ml Standard Deviation 37425.332
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation MMP-9	23974.72 pg/ml Standard Deviation 36530.879	7628.05 pg/ml Standard Deviation 11921.451
Intra-articular Inflammatory Biomarkers at the Time of Definitive Fixation Prostaglandin E2 (PGE2)	709.43 pg/ml Standard Deviation 1165.492	411.76 pg/ml Standard Deviation 646.284

PRIMARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma 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. Using the same needle, the PRP will be delivered. 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	Saline n=2 Participants 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
Number of Participants With Presence of Post-traumatic Osteoarthritis 18 Months After Open Reduction Internal Fixation (ORIF)	0 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma n=2 Participants 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. Using the same needle, the PRP will be delivered. 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	Saline n=5 Participants 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
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	28.96 score on a scale Standard Deviation 4.62
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	48.97 score on a scale Standard Deviation 10.47
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 0.000	6.60 score on a scale Standard Deviation 7.092
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	15.00 score on a scale Standard Deviation 10.000
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	19.50 score on a scale Standard Deviation 4.933
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	5.86 score on a scale Standard Deviation 2.87

SECONDARY outcome

Timeframe: 6 weeks after ORIF

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma n=2 Participants 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. Using the same needle, the PRP will be delivered. 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	Saline n=4 Participants 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
Patient Reported Outcomes (PROs) SF-12 Physical Score	27.47 score on a scale Standard Deviation 11.34	34.39 score on a scale Standard Deviation 2.60
Patient Reported Outcomes (PROs) SF-12 Mental Score	49.09 score on a scale Standard Deviation 13.16	41.48 score on a scale Standard Deviation 5.79
Patient Reported Outcomes (PROs) AOFAS Pain Score	15.00 score on a scale Standard Deviation 21.213	25.00 score on a scale Standard Deviation 5.774
Patient Reported Outcomes (PROs) AOFAS Total Score	15.00 score on a scale Standard Deviation 28.75	21.213 score on a scale Standard Deviation 8.808
Patient Reported Outcomes (PROs) AOFAS Function Score	0.00 score on a scale Standard Deviation 0.000	3.75 score on a scale Standard Deviation 3.775
Patient Reported Outcomes (PROs) VAS Score	5.50 score on a scale Standard Deviation 6.36	3.33 score on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: 12 weeks after ORIF

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma n=1 Participants 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. Using the same needle, the PRP will be delivered. 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	Saline n=4 Participants 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
Patient Reported Outcomes (PROs) SF-12 Physical Score	37.210 score on a scale	42.11 score on a scale Standard Deviation 8.4
Patient Reported Outcomes (PROs) SF-12 Mental Score	60.1 score on a scale	48.67 score on a scale Standard Deviation 13.24
Patient Reported Outcomes (PROs) AOFAS Pain Score	40.00 score on a scale	30.00 score on a scale Standard Deviation 8.16
Patient Reported Outcomes (PROs) AOFAS Total Score	45.00 score on a scale	39.25 score on a scale Standard Deviation 11.383
Patient Reported Outcomes (PROs) AOFAS Function Score	5.00 score on a scale	9.25 score on a scale Standard Deviation 7.042
Patient Reported Outcomes (PROs) VAS Score	1.000 score on a scale	1.7625 score on a scale Standard Deviation 1.017

SECONDARY outcome

Timeframe: 6 months after ORIF

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma n=1 Participants 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. Using the same needle, the PRP will be delivered. 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	Saline n=2 Participants 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
Patient Reported Outcomes (PROs) SF-12 Physical Score	50.62 score on a scale	46.54 score on a scale Standard Deviation 8.91
Patient Reported Outcomes (PROs) SF-12 Mental Score	61.18 score on a scale	39.29 score on a scale Standard Deviation 7.27
Patient Reported Outcomes (PROs) AOFAS Pain Score	30.00 score on a scale	25.00 score on a scale Standard Deviation 7.071
Patient Reported Outcomes (PROs) AOFAS Total Score	45.00 score on a scale	39.50 score on a scale Standard Deviation 10.607
Patient Reported Outcomes (PROs) AOFAS Function Score	15.00 score on a scale	14.50 score on a scale Standard Deviation 3.536
Patient Reported Outcomes (PROs) VAS Score	1.000 score on a scale	3.87 score on a scale Standard Deviation 2.50

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Platelet Rich Plasma 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. Using the same needle, the PRP will be delivered. 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	Saline n=2 Participants 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
Patient Reported Outcomes (PROs) SF-12 Physical Score	—	51.14 score on a scale Standard Deviation 5.9
Patient Reported Outcomes (PROs) SF-12 Mental Score	—	41.13 score on a scale Standard Deviation 24.88
Patient Reported Outcomes (PROs) AOFAS Pain Score	—	30.00 score on a scale Standard Deviation 0.000
Patient Reported Outcomes (PROs) AOFAS Total Score	—	46.50 score on a scale Standard Deviation 2.121
Patient Reported Outcomes (PROs) AOFAS Function Score	—	16.50 score on a scale Standard Deviation 2.121
Patient Reported Outcomes (PROs) VAS Score	—	1.4250 score on a scale Standard Deviation 0.60104

Adverse Events

Platelet Rich Plasma

Serious events: 4 serious events

Other events: 1 other events

Deaths: 0 deaths

Saline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Platelet Rich Plasma n=5 participants at risk 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. 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-s	Saline n=6 participants at risk 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
Musculoskeletal and connective tissue disorders Infection	40.0% 2/5 • Number of events 2 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.	0.00% 0/6 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.
Musculoskeletal and connective tissue disorders Hardware Loosening	20.0% 1/5 • Number of events 1 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.	0.00% 0/6 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.
Musculoskeletal and connective tissue disorders Painful Implants	20.0% 1/5 • Number of events 1 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.	0.00% 0/6 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.

Other adverse events

Other adverse events
Measure	Platelet Rich Plasma n=5 participants at risk 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. 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-s	Saline n=6 participants at risk 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
Musculoskeletal and connective tissue disorders Post-traumatic Osteoarthritis	20.0% 1/5 • Number of events 1 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.	16.7% 1/6 • Number of events 1 • 18 months AEs and SAEs were assessed via a non-systemic approach. Methods of assessment were self-reporting by participants and collection of information from existing medial records for those subjects who did not regularly return for their follow-up visits.

Additional Information

Dr. James Cook

University of Missouri

Phone: 5738827615

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place