"Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Post Operative Pain
- Sponsor
- Brian Walters
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Anterior Knee Pain
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Brian Walters
MD
Northwell Health
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
Outcomes
Primary Outcomes
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 Outcomes
- Radiographic Assessment of Tunnel Positioning(3 months)
- Post Operative Strength(3,6,12,18,24months)
- Post Operative Range of Motion(2 weeks, 1,3,6,12,18,24months)
- Quantification of Healing at the Bony and Tendinous Harvest Sites(6 months)