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

Purpose

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	Intervention	Phase
Post Operative Pain	Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft Biological: Platelet Rich Plasma	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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"

Resource links provided by NLM:

MedlinePlus related topics: Knee Injuries and Disorders Plastic and Cosmetic Surgery

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

Primary Outcome Measures:

Anterior Knee Pain [ Time Frame: 2 weeks, 1, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
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:

Radiographic assessment of tunnel positioning [ Time Frame: 3 months ] [ Designated as safety issue: No ]
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.
Quantification of healing at the bony and tendinous harvest sites [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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.
Post Operative Strength [ Time Frame: 3,6,12,18,24months ] [ Designated as safety issue: No ]
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 [ Time Frame: 2 weeks, 1,3,6,12,18,24months ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	100
Study Start Date:	December 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765712

Locations


United States, New York
NY Orthopedics	Recruiting
New York, New York, United States, 10021
Contact: Stephen Nicholas, MD Snicho55@aol.com
Contact: Brian L Walters, MD 2124342000 ext 2460 briwalters52@gmail.com
Principal Investigator: Stephen J Nicholas, MD
Sub-Investigator: Brian L Walters, MD
Sub-Investigator: Benjamin Bedford, MD
Sub-Investigator: Malachy McHugh, PHD
Sub-Investigator: Sarah Hobart, MD
Sub-Investigator: Rocco Raccanelli, PA
Sub-Investigator: Suzanne Sagues, PA

Sponsors and Collaborators

Brian Walters

Investigators


Principal Investigator:	Stephen Nicholas, MD	North Shore Long Island Jewish Health System

More Information

No publications provided


Responsible Party:	Brian Walters, MD, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:	NCT01765712 History of Changes
Other Study ID Numbers:	12-160A
Study First Received:	January 3, 2013
Last Updated:	April 3, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by North Shore Long Island Jewish Health System:


PRP BPTB VAS Anterior Knee Pain

Additional relevant MeSH terms:


Pain, Postoperative Pain Pathologic Processes Postoperative Complications Signs and Symptoms

ClinicalTrials.gov processed this record on March 02, 2015