This trial is active, not recruiting.

Condition post operative pain
Treatments anterior cruciate ligament reconstruction bone patellar tendon bone autograft, platelet rich plasma
Phase phase 4
Sponsor Brian Walters
Start date December 2012
End date June 2017
Trial size 50 participants
Trial identifier NCT01765712, 12-160A


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
(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.
anterior cruciate ligament reconstruction bone patellar tendon bone autograft ACL
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 At the start of the surgery,just after the administration of anesthesia, 10cc of blood will be withdrawn from the patients IV by the anesthesiologist.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.
anterior cruciate ligament reconstruction bone patellar tendon bone autograft ACL
platelet rich plasma PRP

Primary Outcomes

Anterior Knee Pain
time frame: 2 weeks, 1, 3, 6, 12, 18, 24 months

Secondary Outcomes

Radiographic assessment of tunnel positioning
time frame: 3 months
Quantification of healing at the bony and tendinous harvest sites
time frame: 6 months
Post Operative Strength
time frame: 3,6,12,18,24months
Post Operative Range of Motion
time frame: 2 weeks, 1,3,6,12,18,24months

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Primary ACL Reconstruction - Outerbridge

Additional Information

Official title "Effect of Intraoperative Application of Autologous PRP on Post Operative Morbidity in ACL Reconstruction Using Autologous Bone Patellar Tendon Bone Graft Harvest"
Principal investigator Stephen Nicholas, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Northwell Health.