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

Brian Walters

Status and phase: Completed; Phase 4

Conditions: Post Operative Pain

Treatments: Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft; Biological: Platelet Rich Plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT01765712

12-160A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Description:

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.

Treatment:

Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft

Platelet Rich Plasma

Experimental group

Description:

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.

Treatment:

Biological: Platelet Rich Plasma

Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft