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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by North Shore Long Island Jewish Health System
Sponsor:
Information provided by (Responsible Party):
Brian Walters, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01765712
First received: January 3, 2013
Last updated: April 3, 2014
Last verified: April 2014

January 3, 2013
April 3, 2014
December 2012
December 2014   (final data collection date for primary outcome measure)
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
Anterior Knee Pain [ Time Frame: 2 weeks, 1, 3, 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
The primary outcomen 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
Complete list of historical versions of study NCT01765712 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 defect site [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Post-op MRI's will be obtained to quantifty the amount of bony healing at the donor 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.
Not Provided
Not Provided
 
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Post Operative Pain
  • Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
    Other Names:
    • ACL
    • BPTB
  • Biological: Platelet Rich Plasma
    Other Name: PRP
  • 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.
    Intervention: Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
  • 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.
    Interventions:
    • Procedure: Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
    • Biological: Platelet Rich Plasma
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
Yes
United States
 
NCT01765712
12-160A
Yes
Brian Walters, North Shore Long Island Jewish Health System
Brian Walters
Not Provided
Principal Investigator: Stephen Nicholas, MD North Shore Long Island Jewish Health System
North Shore Long Island Jewish Health System
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP