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

Post Operative Pain Clinical Trial

Official title:

"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01765712
• Other study ID #: 12-160A
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: August 2017

Study information

• Verified date: March 2021
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft

Biological:
• Platelet Rich Plasma

Locations

Country	Name	City	State
United States	NY Orthopedics	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Brian Walters

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
Secondary	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.	3 months
Secondary	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.	6 months
Secondary	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.	3,6,12,18,24months
Secondary	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.	2 weeks, 1,3,6,12,18,24months