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

NCT01765712 | Completed Phase 4 Results DMC

• 1 other identifier: 12-160A
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Operative Pain

Keywords

PRP; BPTB; VAS; Anterior Knee Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Radiographic Assessment of Tunnel Positioning

  3 months

• Quantification of Healing at the Bony and Tendinous Harvest Sites

  6 months

• Post Operative Strength

  3,6,12,18,24months

• Post Operative Range of Motion

  2 weeks, 1,3,6,12,18,24months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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

Platelet Rich Plasma

EXPERIMENTAL

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 At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist.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; Biological: Platelet Rich Plasma

Interventions

Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft PROCEDURE

Also known as: ACL, BPTB

Control Group; Platelet Rich Plasma

Platelet Rich Plasma BIOLOGICAL

Also known as: PRP

Platelet Rich Plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary ACL Reconstruction
• Outerbridge \</= 2
• Minimum follow up of two years
• No ligamentous secondary injury
• Willingness to participate in study

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian Walters: lead

Study Sites (1)

NY Orthopedics

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 29741923 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Malachy McHugh Director of Research
• Organization: Nicholas Institute of Sports Medicine and Athletic Trauma

mchugh@nismat.org

2124342714

Study Officials

• Stephen Nicholas, MD

  Northwell Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 3, 2013
• First Posted: January 10, 2013
• Study Start: December 1, 2012
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: March 24, 2021
• Results First Posted: March 24, 2021

Record last verified: 2021-03

Locations

US (1)