Platelet Rich Plasma Injection in Pilon Fractures

NCT02481869 | Completed Results

• 1 other identifier: 2002117
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Fracture

Keywords

Closed; unilateral; pilon

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

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

  2 weeks after ORIF

• Patient Reported Outcomes (PROs)

  6 weeks after ORIF

• Patient Reported Outcomes (PROs)

  12 weeks after ORIF

• Patient Reported Outcomes (PROs)

  6 months after ORIF

• Patient Reported Outcomes (PROs)

  12 months after ORIF

Study Arms (2)

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.

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.

Drug: Arthrocentesis/Saline

Interventions

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

Also known as: platelet-rich plasma

Arthrocentesis/PRP

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

Also known as: saline

Arthrocentesis/Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Closed unilateral pilon fracture

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

Related Publications (9)

• 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.

  PMID: 12571307 BACKGROUND

• Martin JA, Buckwalter JA. Post-traumatic osteoarthritis: the role of stress induced chondrocyte damage. Biorheology. 2006;43(3,4):517-21.

  PMID: 16912423 BACKGROUND

• 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. doi: 10.1002/art.21812.

  PMID: 16649187 BACKGROUND

• 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. doi: 10.1097/01.blo.0000131233.83640.91.

  PMID: 15232421 BACKGROUND

• 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.

  PMID: 24155495 BACKGROUND

• 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.

  PMID: 25005436 BACKGROUND

• 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.

  PMID: 24858662 BACKGROUND

• 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. doi: 10.1055/s-0031-1297361.

  PMID: 22303754 BACKGROUND

• Thomas 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.

  PMID: 21076249 BACKGROUND

MeSH Terms

Conditions

Fractures, Bone

Interventions

Arthrocentesis; Sodium Chloride

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Paracentesis; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Therapeutics; Surgical Procedures, Operative; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Dr. James Cook
• Organization: University of Missouri

cookjl@health.missouri.edu

5738827615

Study Officials

• Brett D Crist, MD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Co-Director of Trauma Services, Co-Director Orthopaedic Trauma Fellowship, Department of Orthopaedic Surgery

Study Record Dates

• First Submitted: June 11, 2015
• First Posted: June 25, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: February 5, 2021
• Results First Posted: February 5, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)