Clinical trial NCT01765712: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Operative Pain
Keywords: PRP
BPTB
VAS
Anterior Knee Pain
Lead sponsor: Northwell Health
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Anterior Knee Pain
timeFrame: 2 weeks, 1, 3, 6, 12, 18, 24 months. Kneeling pain for treatment groups at 24 months post-op reported.
Secondary outcomes:
measure: Radiographic Assessment of Tunnel Positioning
timeFrame: 3 months
measure: Quantification of Healing at the Bony and Tendinous Harvest Sites
timeFrame: 6 months
measure: Post Operative Strength
timeFrame: 3,6,12,18,24months
measure: Post Operative Range of Motion
timeFrame: 2 weeks, 1,3,6,12,18,24months
Other outcomes:
Locations:
city: New York
country: United States
facility: NY Orthopedics
state: New York
Study officials:
affiliation: Northwell Health
name: Stephen Nicholas, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.