search
Back to results

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

Primary Purpose

Post Operative Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Platelet Rich Plasma
Sponsored by
Brian Walters
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Operative Pain focused on measuring PRP, BPTB, VAS, Anterior Knee Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • NY Orthopedics

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Platelet Rich Plasma

Arm 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.

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 At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist.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.

Outcomes

Primary Outcome Measures

Anterior Knee Pain
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

Radiographic Assessment of Tunnel Positioning
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
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
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
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.

Full Information

First Posted
January 3, 2013
Last Updated
March 1, 2021
Sponsor
Brian Walters
search

1. Study Identification

Unique Protocol Identification Number
NCT01765712
Brief Title
The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
Official Title
"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brian Walters

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Operative Pain
Keywords
PRP, BPTB, VAS, Anterior Knee Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Platelet Rich Plasma
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft
Other Intervention Name(s)
ACL, BPTB
Intervention Type
Biological
Intervention Name(s)
Platelet Rich Plasma
Other Intervention Name(s)
PRP
Primary Outcome Measure Information:
Title
Anterior Knee Pain
Description
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.
Time Frame
2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
Secondary Outcome Measure Information:
Title
Radiographic Assessment of Tunnel Positioning
Description
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.
Time Frame
3 months
Title
Quantification of Healing at the Bony and Tendinous Harvest Sites
Description
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.
Time Frame
6 months
Title
Post Operative Strength
Description
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.
Time Frame
3,6,12,18,24months
Title
Post Operative Range of Motion
Description
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.
Time Frame
2 weeks, 1,3,6,12,18,24months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Nicholas, MD
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NY Orthopedics
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
29741923
Citation
Walters BL, Porter DA, Hobart SJ, Bedford BB, Hogan DE, McHugh MM, Klein DA, Harousseau K, Nicholas SJ. Effect of Intraoperative Platelet-Rich Plasma Treatment on Postoperative Donor Site Knee Pain in Patellar Tendon Autograft Anterior Cruciate Ligament Reconstruction: A Double-Blind Randomized Controlled Trial. Am J Sports Med. 2018 Jul;46(8):1827-1835. doi: 10.1177/0363546518769295. Epub 2018 May 9.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs