The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

The purpose of this research study is to investigate whether or not platelet rich plasma (PRP) may help to improve tendon healing and decrease post operative pain in patients undergoing anterior cruciate ligament (ACL) reconstructive surgery using their own patellar tendons as autografts.

Condition or disease	Intervention/treatment	Phase
Post Operative Pain	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Biological: Platelet Rich Plasma	Phase 4

Detailed Description:

There is currently a paucity of well-designed, prospective, randomized, blinded (Level 1) clinical studies that carefully and comprehensively investigate the role of PRP in ACL surgery. Specifically, ACL reconstruction using Bone Patellar Tendon Bone (BPTB) harvest and the role of PRP in decreasing postoperative pain at the donor site. Given the need for a highly powered study to demonstrate the clinical efficacy of PRP in ACL reconstruction, the investigators have designed a prospective, randomized, level 1, double-blinded study to evaluate the effects of PRP on the specific outcomes of donor site pain and radiographic measures of graft healing and incorporation.

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	50 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Actual Study Start Date :	December 2012
Actual Primary Completion Date :	August 2017
Actual Study Completion Date :	August 2017

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: 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.	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Other Names: ACL; BPTB
Experimental: 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.	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Other Names: ACL; BPTB Biological: Platelet Rich Plasma; Other Name: PRP

Outcome Measures

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Primary Outcome Measures :

1. Anterior Knee Pain [ Time Frame: 2 weeks, 1, 3, 6, 12, 18, 24 months ]
   The primary outcome measured will be anterior knee pain. The investigators will do so by using Visual Analog Scales as an assessment tool. The visual analog scales will include pain with activities of daily living and pain with kneeling activities. Information regarding these pain scales will be collected at 14 days and 1,3,6,12,18 and 24 months

Secondary Outcome Measures :

1. Radiographic assessment of tunnel positioning [ Time Frame: 3 months ]
   A triple view radiographic series of the knee will be performed to assess the position of the tibial and femoral tunnels by one blinded senior radiologist.
2. Quantification of healing at the bony and tendinous harvest sites [ Time Frame: 6 months ]
   Post-op MRI's will be obtained to quantify the amount of bony healing at the donor site and revascularization of native patellar tendon at the harvest site. These images will be interpreted by one blinded senior musculoskeletal radiologist.
3. Post Operative Strength [ Time Frame: 3,6,12,18,24months ]
   The objective clinical assessment of strength in the operative extremity will measured as quadriceps strength in a single leg hop test. This data will be collected by an independent researcher also blinded to treatment.
4. Post Operative Range of Motion [ Time Frame: 2 weeks, 1,3,6,12,18,24months ]
   The patients range of motion will be assessed on both the operative and non-operative knee. This information will be assessed using a goniometer and will be collected by a blinded clinician.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

• Primary ACL Reconstruction
• Outerbridge </= 2
• Minimum follow up of two years
• No ligamentous secondary injury
• Willingness to participate in study

Exclusion Criteria:

• Any previous knee injury
• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New York
NY Orthopedics
New York, New York, United States, 10021

Sponsors and Collaborators

Brian Walters

Investigators

Principal Investigator:	Stephen Nicholas, MD	Northwell Health

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Brian Walters, MD, Northwell Health
ClinicalTrials.gov Identifier:	NCT01765712 History of Changes
Other Study ID Numbers:	12-160A
First Posted:	January 10, 2013
Last Update Posted:	August 14, 2017
Last Verified:	August 2017

Keywords provided by Brian Walters, Northwell Health:

PRP; BPTB; VAS; Anterior Knee Pain

Additional relevant MeSH terms:

Pain, Postoperative; Pain; Neurologic Manifestations; Nervous System Diseases	Postoperative Complications; Pathologic Processes; Signs and Symptoms