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

Phase 4

Completed

Conditions: Post Operative Pain

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

Registration Number: NCT01765712

Lead Sponsor: Brian Walters

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 50

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet Rich Plasma	Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft	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.
Control Group	Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft	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.
Platelet Rich Plasma	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.

Primary Outcome Measures

Name	Time	Method
Anterior Knee Pain	2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.	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. The Visual analog Scale is a score from 0-10 with 0=no pain and 10=excruciating pain.

Secondary Outcome Measures

Name	Time	Method
Radiographic Assessment of Tunnel Positioning	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.
Post Operative Strength	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.
Post Operative Range of Motion	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.
Quantification of Healing at the Bony and Tendinous Harvest Sites	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.