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

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ClinicalTrials.gov Identifier: NCT01765712
Recruitment Status : Completed
First Posted : January 10, 2013
Results First Posted : March 24, 2021
Last Update Posted : March 24, 2021
Sponsor:
Information provided by (Responsible Party):
Brian Walters, Northwell Health

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.

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Study Type : Interventional  (Clinical Trial)
Actual 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

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Anterior Knee Pain [ Time Frame: 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 :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01765712


Locations
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United States, New York
NY Orthopedics
New York, New York, United States, 10021
Sponsors and Collaborators
Brian Walters
Investigators
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Principal Investigator: Stephen Nicholas, MD Northwell Health
  Study Documents (Full-Text)

Documents provided by Brian Walters, Northwell Health:
Informed Consent Form  [PDF] September 5, 2012

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Brian Walters, MD, Northwell Health
ClinicalTrials.gov Identifier: NCT01765712    
Other Study ID Numbers: 12-160A
First Posted: January 10, 2013    Key Record Dates
Results First Posted: March 24, 2021
Last Update Posted: March 24, 2021
Last Verified: March 2021
Keywords provided by Brian Walters, Northwell Health:
PRP
BPTB
VAS
Anterior Knee Pain
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations