The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
NCT ID: NCT01765712
Last Updated: 2021-03-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
50 participants
INTERVENTIONAL
2012-12-31
2017-08-31
Brief Summary
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Detailed Description
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The aim of this study is to evaluate the efficacy of intra-operatively applied autologous PRP in reducing donor site morbidity and increasing radiographic healing in ACL reconstruction using autologous BPTB.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control Group
Patients will be randomized into the treatment arm using a computer generated randomization table (simple randomization). Patients in the control arm of the study will undergo Anterior cruciate ligament reconstruction using Autologous bone patellar tendon bone autograft. At the end of the surgery, their graft donor site will have bone graft chips placed into the bony defect and the wound will be closed using sutures.
Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Platelet Rich Plasma
Patients randomized into the treatment arm of the study will undergo Anterior cruciate ligament reconstruction with Autologous bone patellar tendon bone autografts. At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist. This sample will be spun down into 3-5cc of Platelet Rich Plasma which will be added to the patients bone graft chips and placed into the donor site at the end of the case.
Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Platelet Rich Plasma
Interventions
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Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Platelet Rich Plasma
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Outerbridge \</= 2
* Minimum follow up of two years
* No ligamentous secondary injury
* Willingness to participate in study
Exclusion Criteria
* prior history of anterior knee pain
* Outerbridge classification 3 or greater
* Revision ACL
* Diabetic or smoker
* Workers compensation patient
* pregnant or nursing women
* Any patient with limited English Proficiency
18 Years
ALL
Yes
Sponsors
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Brian Walters
OTHER
Responsible Party
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Brian Walters
MD
Principal Investigators
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Stephen Nicholas, MD
Role: PRINCIPAL_INVESTIGATOR
Northwell Health
Locations
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NY Orthopedics
New York, New York, United States
Countries
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References
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Walters BL, Porter DA, Hobart SJ, Bedford BB, Hogan DE, McHugh MM, Klein DA, Harousseau K, Nicholas SJ. Effect of Intraoperative Platelet-Rich Plasma Treatment on Postoperative Donor Site Knee Pain in Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2018 Jul;46(8):1827-1835. doi: 10.1177/0363546518769295. Epub 2018 May 9.
Provided Documents
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Document Type: Informed Consent Form
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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12-160A
Identifier Type: -
Identifier Source: org_study_id
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