Platelet Rich Plasma (PRP) Treatment of the Anterior Cruciate Ligament Injured Knee to Decrease the Risk of Post-traumatic Osteoarthritis (PTOA): a Randomized Double-blind Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of our study is to examine the effect of platelet-rich-plasma (PRP) injection on the short-term resolution of post-injury inflammation (biomarkers) and improvement in joint function in patients with acute ACL injury. This RCT has been powered based on the questionnaire KOOS Jr. but it is considered a 'pilot study' in terms of the lab analysis proposed.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 50
Healthy Volunteers: f
View:
• Acute ACL injury within 6 weeks of presentation
• Age 14-50
• Male or female
• Meniscus injury that can be treated with meniscectomy or repair (the lack of meniscus injury will not exclude patients)
Locations
United States
New York
Hospital for Special Surgery
RECRUITING
New York
Contact Information
Primary
Jessica Andres-Bergos, PhD
andresbergosj@hss.edu
(917) 260-4694
Time Frame
Start Date: 2022-06-27
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 56
Treatments
Placebo_comparator: Control Arm
The control arm will receive a pre-op placebo injection of saline, and ACLR surgery with intra-op placebo injection
Experimental: Investigational Arm
The investigational arm will receive a pre-op PRP injection, and ACLR surgery with PRP injection
Related Therapeutic Areas
Sponsors
Leads: Hospital for Special Surgery, New York
Collaborators: Orthopedic Research and Education Foundation